20Mar
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Additional Indication for Keytruda

The U.S. Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab – Merck) for use in certain patients with classical Hodgkin lymphoma (cHL). On March 14, 2017, Keytruda gained an indication for use in patients whose cHL either has not responded to other therapies or has recurred despite at least three previous treatments. For cHL, the recommended adult dose is 200mg. For children, the dose is 2mg/kg up to a maximum of 200mg. Keytruda is given as an intravenous (IV) infusion once every three weeks until cHL gets worse or the drug’s side effects become unbearable. If cHL does not progress, treatment can continue for as long as two years. Originally approved in 2014 to treat advanced melanoma, Keytruda also has indications for non-small cell lung cancer and head and neck cancers. It is a human programmed death receptor-1 (PD-1)-blocking antibody that boosts the immune system’s ability to attack cancer cells. Complete prescribing information is available here.

Generics to Minastrin 24 FE Chewable Tablets Now Available

On March 16, 2017, Lupin announced the launch of its A-rated generics to Minastrin® 24 Fe chewable tablets. The oral contraceptive 28-day pack contains 24 norethindrone acetate and ethinyl estradiol (1mg / 0.02mg) chewable tablets and four non-hormonal ferrous fumarate tablets (75mg). While approved by FDA in May 2016, Lupin has now launched its generic with the trade name of Mibelas 24 Fe. Teva also launched an authorized generic to this product, which is essentially the brand drug repackaged into generic-looking packaging. According to IMS Health, Minastrin 24 Fe chewable tablets had U.S. sales of approximately $360 million for the 12 months ending December 2016.

Repatha Cardiovascular Outcomes Issues Document Available

Repatha® (evolocumab – Amgen) is a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor antibody that is highly effective at lowering low-density lipoprotein cholesterol (LDL-C) levels. On March 17, 2017, Amgen’s FOURIER study (n = 27,564) was published in the New England Journal of Medicine. The study shows that when Repatha was added to statin therapy (± Zetia,) the risk of the composite endpoint of cardiovascular (CV) death, myocardial infarction (MI), stroke, hospitalization for unstable angina, or coronary revascularization was reduced by 15% among patients who had clinically evident atherosclerotic cardiovascular disease (ASCVD) compared with patients who received only background statin therapy (± Zetia). This Issues Document summarizes Repatha’s clinical outcomes trial, provides a patent litigation update concerning Repatha and Praluent® (alirocumab – Sanofi/Regeneron) and highlights how Express Scripts’ Pharmacy and Therapeutics (P&T) committee will review the FOURIER data, make appropriate alterations in utilization management (UM) programs and continue to assess the formulary status within this class of medications.  The Issues Document is available here

MedWatch
Viberzi

On March 15, 2017, FDA issued a MedWatch alert for Allergan’s Viberzi® (eluxadoline) tablets. Since Viberzi’s U.S. approval in May 2015 to treat irritable bowel syndrome with diarrhea (IBS-D), FDA has investigated 120 reports of pancreatitis among patients using it. At least 76 patients had to be hospitalized and two patients died. Specifically, patients who have had their gallbladders removed are at increased risk. FDA is recommending that physicians prescribe medications other than Viberzi for patients without gallbladders. Additionally, it suggests that patients discuss alternative treatment choices with their doctors. Patients who take Viberzi are cautioned to watch for signs of pancreatitis, such as nausea and vomiting or severe abdominal/stomach pain that may also affect the back or right shoulder, whether or not their gallbladders have been removed. FDA’s full Safety Communication is available here.    

 
14Mar

The Governors of Maryland, New Jersey, New York, Connecticut, and Virginia have declared States of Emergency

The Governors of Maryland, New Jersey, New York, Connecticut, and Virginia have declared States of Emergency due to Winter Storm Stella impacting all counties in each state. Express Scripts (FSBP's Pharmacy Benefit Manager) has activated the Emergency Access to Benefits/Refill Too Soon override process for the impacted areas with an effective date of March 14, 2017 and expiration date of April 13, 2017 that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide temporary alternate addresses (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed.

 
14Mar
Express Scripts News Flash

Express Scripts News Flash

Kisqali Approved to Treat Breast Cancer

The U.S. Food and Drug Administration (FDA) approved Kisqali® (ribociclib -- Novartis) on March 13, 2017. Kisqali is indicated as first-line treatment for postmenopausal women who have metastatic or advanced hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) breast cancer. It selectively inhibits cyclin-dependent kinase (CDK) 4 and 6 (CDK4/6), enzymes that promote the growth and spread of cancer cells. It will be used in combination with an aromatase inhibitor, such as anastrozole, exemestane or letrozole. Recommended dosing is on four-week cycles, with 600mg (three tablets) of Kisqali taken once daily every day for 21 days, then stopped for the next seven days. The aromatase inhibitor is taken continually without a break. Kisqali will be distributed through an open network. Its complete prescribing information is available here

  • Brand (Generic) Name: Kisqali® (ribociclib)
  • Manufacturer: Novartis
  • Date Approved: March 13, 2017
  • Indication: Treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.
  • Dosage Forms Available: 200mg tablets
  • Launch Date: Novartis plans to launch within a few days of approval.
  • Estimated Annual Cost: The wholesale acquisition cost of a 28-day supply of the 600mg dose is $10,950 or approximately $142,700 per year.
  • Specialty Status:  Kisqali will be added to the Express Scripts specialty drug list
  • According to the American Cancer Society, approximately 250,000 cases of invasive breast cancer are diagnosed, annually.  More than 70 percent of those cases are HR+/HER2-.
  • In the main clinical study, average progression-free survival was about nine months longer for participants taking Kisqali plus letrozole compared with patients taking letrozole by itself (25.3 months vs. 16.0 months).
  • Kisqali may cause QT prolongation, which is an abnormal heartbeat that may lead to death.  A baseline electrocardiogram (ECG) should be taken before treatment begins, about halfway through the first line treatment cycle, at the start of the second cycle and then periodically during treatment.  Additionally, electrolyte levels should be tested at the beginning of the first six cycles and then at regular intervals. 
  • Liver function also should be checked before starting therapy, every two weeks during the first two cycles, at the start of the next four cycles and then as considered appropriate.
  • The only other CDK4/6 inhibitor currently FDA approved for treating breast cancer is Pfizer's lbrance (palbociclib).  It is indicated for use only with letrozole, not with other aromatase inhibitors.  It does not, however, require heart or liver monitoring.
  • FDA designated Kisqali as a breakthrough therapy and approved it ahead of schedule under priority review.
 
14Mar

AFSPA opens at 10:30AM - 3/14/17

AFSPA is opening at 10:30am (EDT), today, Tuesday, March 14, 2017.

Thank you.

 
14Mar

AFSPA is opening late today

Due to inclement weather and following the decision by the Office of Personnel Management, AFSPA will open on a delayed schedule today, Tuesday, March 14, 2017. We will assess staff levels on an ongoing basis with the goal of commencing regular business operations as soon as possible.

Thank you.

 

 

 
13Mar
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Noctiva Approved to Treat Nighttime Urination

The U.S. Food and Drug Administration (FDA) approved Serenity Pharmaceutical’s Noctiva™ (desmopressin) nasal spray on March 3, 2017. It is indicated to treat adults who have nocturnal polyuria. Also called nocturia, the condition wakes patients with the need to urinate twice or more during the night. An analog of the hormone vasopressin, Noctiva temporarily increases the amounts of water the kidneys reabsorb to decrease urine output during the night. Recommended dosing is one spray per day around one-half hour before bedtime. It will be dispensed in containers holding a 30-day supply of either 0.83mcg or 1.66mcg strength. A boxed warning on its labeling and a Medication Guide for patients caution that it may cause hyponatremia (abnormally low levels of blood sodium). Before it is prescribed, the patient should have a 24-hour urine collection test to measure nighttime urine production. Patients using it will need to have sodium levels checked before starting Noctiva, within one week, after one month and then at regular intervals. Several other brand and generic desmopressin products, including oral, injectable and nasal forms, are available in the United States. However, only Noctiva currently is approved for treating patients with nocturia. Launch and pricing plans have not yet been announced. Complete prescribing information is available here.  

New Indication and Boxed Warning for Technivie

Based on results from the phase III AGATE-1 clinical trial, the US Food and Drug Administration (FDA) has approved a new indication for AbbVie’s Technivie® (ombitasvir/paritaprevir/ritonavir). It now can be used, along with ribavirin, to treat patients who have both type 4 chronic hepatitis C and compensated cirrhosis. After 12 weeks, nearly all study participants (all were taking the Technivie/ribavirin regimen) achieved a sustained virologic response (SVR). Extending treatment for an additional four weeks did not improve SVR rates. Recommended dosing is two Technivie tablets taken once each morning. Ribavirin is divided into two daily doses and taken with food. Dosing for ribavirin is determined by the patient’s weight --1,000mg per day for patients who weigh less than 75 Kg (165 pounds) or 1,200mg per day for those who weigh more. The FDA also added a boxed warning that using Technivie could activate hepatitis B virus (HBV) for patients who have or who have had HBV. Patients should be tested for HBV before, during and for several months after treatment. Revised prescribing information is available here

 
13Mar
AFSPA Closing Early at 4:30pm EST (3/13/17)

AFSPA Closing Early at 4:30pm EST (3/13/17)

Due to an expected winter storm, AFSPA will be closing its offices at 4:30pm EST today, Monday, March 13, 2017. The goal is to allow AFSPA staff to get home safely in advance of any bad weather. As a reminder, AFSPA follows the Federal government schedule for openings and closures. AFSPA will update its phone system, website, and Facebook regarding any weather-related closings resulting from inclement weather.

 
6Mar
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Combination Diabetes Drug Approved

Qtern® (dapagliflozin/saxagliptin) tablets were approved by the U.S. Food and Drug Administration (FDA) on Feb. 27, 2017. Qtern is indicated, together with diet modifications and exercise, to treat adults who have type 2 diabetes that is not controlled by dapagliflozin (Farxiga®) alone. Patients already taking dapagliflozin and saxagliptin (Onglyza®) separately also are candidates for the combination product. Dapagliflozin is a sodium-glucose co-transporter 2 (SGLT-2) inhibitor that helps the body to eliminate more blood sugar in urine. Saxagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, promotes release of natural insulin and blocks release of glucose when blood sugar levels are high. A Medication Guide that accompanies Qtern warns patients that dapagliflozin potentially can increase the risk of dehydration, genital yeast infections, heart failure and/or bladder cancer. Additionally, the guide cautions that patients taking saxagliptin may be slightly more likely to have inflammation of the pancreas. Kidney function should be tested before beginning therapy and occasionally throughout treatment. AstraZeneca plans to launch Qtern later in 2017, but no cost information is available, yet. Recommended dosing is one tablet, containing 10mg of dapagliflozin and 5mg of saxagliptin, taken once each morning. Complete prescribing information is available here.  

Dust Mite Allergy Drug, Odactra, Approved

On March 1, 2017, FDA approved Odactra for adults between 18 years and 65 years of age who have nasal inflammation (allergic rhinitis) that may be accompanied by eye inflammation (conjunctivitis) from an allergy to dust mites. It is oral immunotherapy which contains small amounts of dust mite allergens. In clinical studies, symptoms for patients using it decreased about 16% to 18%. Full results may take up to 14 weeks to be achieved, however. Taken as sublingual tablets, Odactra dissolves under the tongue. Recommended dosing is once a day continually, with the first dose in a physician’s office or clinic to be sure the allergens in Odactra do not result in serious side effects. A boxed warning on the labeling cautions patients that severe allergic reactions, such as potentially life-threatening drops in blood pressure and breathing difficulties, are possible with its use. ALK-Abello will be distributing Odactra. Launch and pricing plans as well as the prescribing information have not yet been released.

 
6Mar
From the CEO

From the CEO

Welcome to March 2017! Spring means new beginnings. AFSPA is working on our annual Spring newsletter. We believe it is important to stay connected with our members and provide the latest health information. Please expect to see the Spring newsletter in your mailbox in the upcoming months.

The year 2017 is very important for us as it marks 75 years since the Foreign Service Benefit Plan (FSBP) was established. In 1942, the American Foreign Service Protective Association (AFSPA) began offering health insurance to those in the Foreign Service. Now we have evolved to serve many agencies with a Foreign Affairs involvement, such as DOD, DHS, CIA, etc. We are very proud of offering worldwide coverage for over seven decades. We designed a special logo to commemorate this milestone occasion. You can view it on the FSBP web page throughout the entire year. Click here to view the 75th Anniversary logo now. Caring for your Health Worldwide for 75 years has been an honor and a privilege. Thank you for your loyalty to the Plan.

Springtime also is a time we finalize our taxes. Filing taxes is often stressful and even more so while living abroad. AFSPA partners with Beers, Hamerman, Cohen & Burger, P.C. to offer our members special discounts and top-notch tax services. You may remember reading their articles regarding the Affordable Care Act’s impact for members living abroad in past newsletters.  AFSPA members are able to work with one of five CPA tax accountants, each with at least ten years’ accounting experience. You receive a complimentary 20-minute consultation and a 10% discount off standard hourly rates. Email [email protected] or call 203-787-6527 to utilize these services today. Simply identify yourself as an AFSPA member – retired or active – when you contact the firm. Take advantage of this worthwhile tax services today.

Lastly, March is National Nutrition Month. It focuses attention on the importance of making informed food choices and developing sound eating and physical activity habits. This would be a great time to explore the Mediterranean Wellness Program offered to all FSBP members. The eight week interactive online program gives you access to a registered dietician. It also offers a support manual with information to help manage your weight. If you didn’t know, the Mediterranean Wellness Program counts as a Healthy Action for those completing the Simple Steps to Living Well Together Program. So start your path to better eating and earn a $50 incentive credit today. Please refer to the 2017 FSBP Brochure, Section 5(h) to explore the many other programs that can help members with nutrition goals, including our Weight Management Program, Health Coaching Program, and  TherapEase Cuisine, just to name a few. And, don’t forget the Plan’s Nutritional Counseling benefit.  See your Brochure in Section 5(a) for more information on this benefit.

A reminder, we mailed the IRS Form 1095-B to FSBP members last week. Please note, the 1095-B form is not needed to file your tax return but it should be kept in your 2016 tax file.

We hope your family has a happy and healthy Spring. As always, thank you for your trust and for giving AFSPA the opportunity to serve you.

 

To Your Health,

Paula S. Jakub, RHU
CEO, AFSPA
Executive Director, Senior Living Foundation  

 
2Mar
Express Scripts News Flash

Express Scripts News Flash

Xermelo Approved to Treat Diarrhea of Carcinoid Syndrome and Generics to Pristiq Launched

Xermelo Approved

On Feb. 28, 2017, the U.S. Food and Drug Administration (FDA) approved Lexicon Pharmaceuticals’ Xermelo™ (telotristat ethyl) tablets. It will be used along with a somatostatin analog, such as octreotide, to manage diarrhea associated with carcinoid syndrome for adults whose diarrhea is not controlled adequately by a somatostatin analog, alone. The first drug to be FDA approved in the new class of tryptophan hydroxylase inhibitors, Xermelo reduces the excess secretion of serotonin caused by the tumors. Recommended dosing is one tablet three times a day with food. Generally, long-acting forms of somatostatin analogs are injected intramuscularly (IM) once monthly; short-acting forms are given subcutaneously (SC) two times to four times a day. If a short-acting somatostatin analog is used, it should be injected at least one-half hour after Xermelo is taken. Beginning March 6, 2017, Xermelo will be available through a select group of specialty pharmacies that does not include Accredo. Complete prescribing information is available here

  • Brand (Generic) Name: Xermelo™ (telotristat ethyl)
  • Manufacturer: Lexicon Pharmaceuticals
  • Date Approved: Feb. 28, 2017
  • Indication: To treat adults who have carcinoid syndrome diarrhea that somatostatin therapy alone has inadequately controlled
  • Dosage Forms Available: 250mg tablets
  • Launch Date: March 6, 2017
  • Estimated Annual Cost: The wholesale acquisition cost (WAC) of Xermelo will be approximately $67,300 per year.
  • Specialty Status:  Xermelo will be added to Express Scripts’ specialty drug list.
  • Neuroendocrine tumors contain both nerve cells and cells that produce hormones
  • A rare type of neuroendocrine cancer, carcinoid tumors usually begin in the digestive tract or lungs. They develop slowly and their early symptoms are similar to those of many other conditions. Most cases are not diagnosed until the tumors have spread – often to the liver. According to the American Society of Clinical Oncology, about 12,000 American adults are diagnosed with carcinoid tumors each year.
  • Many patients with carcinoid tumors develop carcinoid syndrome, which partly results from excessive production of the neurotransmitter, serotonin. Symptoms include abdominal pain, breathing difficulty, severe diarrhea, facial flushing and heart problems
  • By blocking the activity of the enzyme tryptophan hydroxylase, Xermelo decreases the production of serotonin and lessens diarrhea
  • Xermelo will be used along with a somatostatin analog, such as octreotide.

Generics to Pristiq Launched

Desvenlafaxine extended-release tablets, generic for Pfizer’s Pristiq®, were launched in the United States on March 1, 2017. A once-daily selective serotonin and norepinephrine reuptake inhibitor (SNRI), it is indicated to treat adults who have depression. A boxed warning advises that it should not be used for children or teens, because they might think about or attempt suicide while taking it. Several companies, including Breckenridge Pharmaceutical, Inc. and Teva Pharmaceutical Industries, will share 180-day exclusivity. In 2016, U.S. sales of Pristiq amounted to about $883 million, according to IMS Health.

  • Brand Drug:Pristiq® (desvenlafaxine, extended-release – Pfizer)
  • Indication: Treatment of adults with major depressive disorder
  • Generic Manufacturers: Breckenridge, Teva and several others expected
  • Dosage Forms Available: 25mg, 50mg and 100mg extended-release tablets. Teva is expected to have 180 days of marketing exclusivity for the 25mg strength
  • Launch Date: March 1, 2017
  • Annual US Sales: $883 million
 
27Feb
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Revlimid Receives New Indication

Revlimid® (lenalidomide), an oral immunomodulatory drug from Celgene, received a new U.S. Food and Drug Administration (FDA) indication on Feb. 22, 2017. In addition to its previous approvals for treating mantle cell lymphoma (MCL), multiple myeloma (MM) and anemia related to transfusions for myelodysplastic syndromes (MDS); Revlimid now is approved for maintenance treatment of patients who have had autologous hematopoietic stem cell transplants (auto-HSCT) for MM. Recommended initial dosing is 10mg daily for 84 days. The dose then is raised to 15mg daily, if the patient can tolerate the higher dose. In clinical studies, progression-free survival ranged from about 1.5 years to about 3.8 years longer for auto-HSCT patients treated with Revlimid than for untreated patients. A Medication Guide and boxed warnings on Revlimid’s labeling caution that using it during pregnancy can cause birth defects or death for the fetus, and that it increases the risks of blood clots, heart attacks, strokes and/or blood abnormalities. Its use is limited through the Revlimid Risk Evaluation and Mitigation Strategy (REMS) Program, which requires patients, pharmacies and prescribers to be authorized before using, dispensing or prescribing it. Revlimid’s revised prescribing information is available here.  

 
21Feb
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

New Indication for Spiriva Respimat

The U.S. Food and Drug Administration (FDA) approved a pediatric indication for Spiriva® Respimat® (tiotropium – Boehringer Ingelheim) on February 15, 2017. Spiriva Respimat is a long-acting muscarinic antagonist (LAMA) that uses a propellant-free device to deliver the drug as a fine, slow mist, which helps patients inhale the medication. Originally approved in September 2014 for treating chronic obstructive pulmonary disease (COPD), it was granted an additional FDA approval a year later for long-term maintenance treatment of asthma patients at least 12 years old. The new indication now allows its use as a controller (maintenance) treatment for asthma patients as young as six years old. Recommended dosing is two inhalations once a day. The best level of improvement may take four weeks to eight weeks of therapy to achieve. Updated prescribing information is available here. 

 
16Feb
Express Scripts News Flash

Express Scripts News Flash

Siliq Approved for Psoriasis

Siliq™ (brodalumab — Valeant) was approved by the U.S. Food and Drug Administration (FDA) on February 15, 2017. It is a monoclonal antibody that selectively binds to the interleukin (IL)-17 receptor. It is indicated to treat adults who have moderate-to-severe plaque psoriasis. Siliq should be used in patients who are eligible for systemic (oral or injected) treatment or phototherapy, but already have tried systemic treatments that either stopped working or did not work at all. Recommended dosing is one subcutaneous (SC) injection (210mg) once a week for three doses, and then once every two weeks. Siliq has a boxed warning that it may cause patients to consider or try suicide. Its use will be regulated under a Risk Evaluation and Mitigation Strategy – Siliq REMS. Patients, physicians and pharmacists all must be authorized before using, prescribing or dispensing Siliq. Valeant plans on launching Siliq in the second half of 2017. It will be available through open distribution; Accredo Specialty Pharmacy will be dispensing Siliq. Complete prescribing information is available here

  • Brand (Generic) Name: Siliq™ (brodalumab)
  • Manufacturer: Valeant Pharmaceuticals
  • Date Approved: Feb. 15, 2017
  • Indication: Treatment of moderate to severe plaque psoriasis for adult patients who are candidates for systemic therapy or phototherapy and who have failed to respond or have lost response to other systemic therapies.
  • Dosage Forms Available: 5mL single-use pre-filled syringes each containing 210mg of Siliq
  • Launch Date: Second half of 2017
  • Estimated Annual Cost: Pricing information is not yet available.
  • Specialty Status:  Siliq will be added to Express Scripts' specialty drug list
  • Plaque psoriasis is an autoimmune inflammatory condition that causes itchy, white patches on the skin. It affects approximately 3% of adults – over 7 million people – in the U.S.
  • By blocking the IL-17 receptor, Siliq interrupts the process of inflammation to reduce psoriasis activity.
  • In clinical trials, psoriasis was completely cleared for over 60% of the patients treated with Siliq for 12 weeks. More than eight of 10 actively treated patients showed 75% or more improvement.
  • Labeling for Siliq has a boxed warning that it may cause patients using it to think about or attempt suicide.
  • Siliq will compete with Cosentyx® (secukinumab – Novartis) and Taltz® (ixekizumab – Lilly), which bind to the IL-17A cytokine, as opposed to Siliq, which binds to IL-17 receptors.
 
15Feb

Member Portal Services Restored

Dear Members,

Our Member Portal services have been restored. Thank you for your patience.
 

Yancy Meiller
IT Manager
 

 
15Feb

MEMBER PORTAL CURRENTLY DOWN

Dear Members,

Please be advised we are currently experiencing technical difficulties with our Member Portal. We are working to restore services as soon as possible. This has not affected the security of the data. We appreciate your patience and we apologize for the inconvenience this has caused.

If you would like to receive notification once this issue is resolved, please use the secure form here:
https://www.afspa.org/secureform.cfm?formname=Contact%20AFSPAconnect

Thank you,


Yancy Meiller
IT Manager

 
14Feb
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Gammaplex 10% Approved for Immune Deficiencies

On February 6, 2017, the U.S. Food and Drug Administration (FDA) approved Gammaplex® 10% (immune globulin intravenous [human], 10% liquid). It is indicated to treat adults who have primary immunodeficiency (PI) or chronic immune thrombocytopenic purpura (ITP). The manufacturer, Bio Products Laboratory, also markets Gammaplex® 5% (immune globulin intravenous [human], 5% liquid in the United States. Intravenous immunoglobulins (IVIGs), are used as replacement for patients who have immunoglobulin deficiencies. They are dosed by weight. For treating PI, one Gammaplex 10% infusion is recommended every three to four weeks. Recommended dosing for the treatment of ITP is one infusion on each of two successive days when needed to increase platelet count. In clinical studies, the average infusion time for the 10% strength was about one hour – approximately one-half the average time for an infusion of Gammaplex 5%. Labeling for all IVIG products includes warnings that they may cause blood clots, kidney damage or kidney failure. Complete prescribing information for Gammaplex 10% is available here.

 
13Feb

THE GOVERNOR OF CALIFORNIA HAS DECLARED A STATE OF EMERGENCY

The Governor of California has declared a State of Emergency for the following counties due to flooding: Butte, Sutter and Yuba.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an emergency benefit override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide temporary alternate addresses (either online at www.express-scripts.com  or by calling 1-800-818-6717) or request a local fill as needed.

 
12Feb
Express Scripts News Flash

Express Scripts News Flash

Emflaza Approved for Duchenne Muscular Dystrophy

On February 9, 2017, the U.S. Food and Drug Administration (FDA) approved Marathon Pharmaceuticals’ Emflaza™ (deflazacort). It is indicated to treat patients with Duchenne muscular dystrophy (DMD) who are five years of age and older. Emflaza is an oral corticosteroid that decreases both immune and inflammatory activity to relieve symptoms of DMD and also to delay progression of the disease. The recommended dose is 0.9mg/kg once daily. Emflaza is expected to be launched in four to six weeks. It will be available through a limited network of specialty pharmacies that does not include Accredo. Full prescribing information is available here.  

  • Brand (Generic) Name: Emflaza™ (deflazacort)
  • Manufacturer: Marathon Pharmaceuticals
  • Date Approved: Feb. 9, 2017
  • Indication: To treat patients who have Duchenne muscular dystrophy (DMD) and who are at least five years old
  • Dosage Forms Available:  6mg, 18mg and 36mg oral tablets and 22.75mg/mL oral suspension
  • Launch Date: Emflaza is expected to be available within four to six weeks.
  • Estimated Annual Cost: Pricing information is not available at this time.
  • Specialty Status:  Emflaza will be added to Express Scripts' specialty drug list
  • Although rare, DMD is the most common form of muscular dystrophy — with about 400 to 600 new cases diagnosed in the United States each year. A condition almost exclusively affecting boys and young men, it causes progressive muscle weakening that usually leads to paralysis during the teen years and death in early adulthood.
  • Several corticosteroids are used to treat DMD, but Emflaza is the first to be specifically approved to treat the condition.
  • In clinical studies that lasted as long as two years, patients taking Emflaza lost less muscle strength than those taking a placebo.
 
9Feb
Clinical Matters News Flash

Clinical Matters News Flash

Parsabiv Approved to Treat Secondary Hyperparathyroidism

Amgen announced on February 7, 2017, that the U.S. Food and Drug Administration (FDA) had approved Parsabiv™ (etelcalcetide). It is indicated to treat hyperparathyroidism (HPT) caused by hemodialysis for adults with chronic kidney disease (CKD). Secondary HPT is a condition that results from over production of parathyroid hormone (PTH) from the parathyroid glands, which are stimulated by low kidney function. In response, additional calcium and other minerals are lost from bones into the blood. Parsabiv acts like calcium at receptors on the parathyroid glands to decrease PTH release. Given as an intravenous (IV) infusion, it can be injected into the tubing used for dialysis after each dialysis treatment ends. Recommended initial dose is 5mg three times a week. Maintenance doses range from 2.5mg to 15mg three times a week as long as calcium blood levels are too high. Prescribing information is available here

  • Brand (Generic) Name: Parsabiv™ (etelcalcetide)
  • Manufacturer: Amgen
  • Date Approved: Feb. 7, 2017
  • Indication: Secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis
  • Dosage Forms Available:  Single-use vials containing 2.5mg, 5mg or 10mg of Parsabiv
  • Launch Date: Launch date isn’t known at this time.
  • Estimated Annual Cost: Pricing information is not available at this time
  • According to the National Kidney Foundation, the majority of more than 460,000 U.S. adults using dialysis will develop HPT.
  • In clinical studies, targeted reductions in PTH were met by at least 52% of patients being treated with Parsabiv as compared with only 5% to 11% of those receiving a placebo.
  • Both calcium and PTH levels should be tested after beginning Parsabiv, with dosing changes about once a month during therapy
  • Parsabiv works similar to Amgen's oral product, Sensipar® (cinacalcet), which is expected to face generic competition in September 2018.
 
8Feb

THE GOVERNOR OF LOUISIANA HAS DECLARED A STATE OF EMERGENCY

The Governor of Louisiana has declared a State of Emergency for the entire state of Louisiana due to severe storms.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an emergency benefit override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide temporary alternate addresses (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed

 
6Feb
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

ArmonAir RespiClick and AirDuo RespiClick  Asthma Inhalers Approved

The U.S. Food and Drug Administration (FDA) has awarded Teva Pharmaceutical Industries Ltd. approvals for two new dry-powder inhalers. ArmonAirTM RespiClick® (fluticasone propionate) and AirDuoTM RespiClick® (fluticasone propionate/salmeterol) were approved on Jan. 27, 2017. Indicated for maintenance treatment of asthma for patients who are at least 12 years old, they will be released later in 2017. Both contain the corticosteroid, fluticasone propionate. Since using corticosteroids orally can lead to oropharyngeal candidiasis (fungal infections of the mouth and throat), patients using either ArmonAir RespiClick or AirDuo RespiClick are advised to rinse out their mouths with plain water after each inhalation. Recommended dosing for each is one inhalation two times a day. Neither is intended for relief of acute asthma attacks. Patients with serious reactions to milk should not use them. ArmonAir RespiClick’s prescribing information is available here.   

Because it also contains the long-acting beta2 agonist (LABA), salmeterol, AirDuo RespiClick’s labeling has boxed warnings that it increases the risk of death due to asthma and that using it may also raise the chance of hospitalization for children and teens. It should be reserved for patients whose asthma is not well managed by another maintenance medication for asthma. Full prescribing information for AirDuo RespiClick is available here.  

Expanded Indication for Latuda

In a press release dated Jan. 28, 2017, Sunovion Pharmaceuticals disclosed that it had received FDA approval for Latuda® (lurasidone) to treat schizophrenia for patients between 13 years and 18 years old. Recommended dosing is one tablet daily taken with food. Latuda can be used alone or in combination with other drugs, such as lithium. Clinical studies of its effectiveness for teens lasted six weeks. Therefore, prescribers are advised to evaluate the need for treatment if therapy lasts longer. Latuda, an atypical antipsychotic, also is approved to treats adults who have schizophrenia or major depression related to bipolar disorder. Updated prescribing information is available here. 

Opdivo Gains New Indication

On Feb. 2, 2017, Bristol-Myers Squibb’s Opdivo® (nivolumab) was FDA approved for treating locally advanced or metastatic urothelial carcinoma (mUC) that has progressed either during or after platinum-containing chemotherapy. It also may be used within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. A form of bladder cancer, mUC affects about 70,000 Americans a year. Over one-half of patients experience a relapse after treatment. To treat mUC recurrence, the recommended dose of Opdivo is 240mg infused intravenously (IV) once every two weeks until the patient no longer responds or no longer tolerates side effects. Opdivo is a programmed death receptor-1 (PD-1) inhibitor. As an immuno-oncology agent, it helps the body’s immune system attack cancer cells. Since its initial U.S. approval to treat metastatic melanoma in December 2014, Opdivo has been approved, either alone or in combination with other oncology drugs, to treat several other cancer types, including metastatic non-small cell lung cancer (NSCLC) and renal cell carcinoma (RCC). Updated prescribing information is available here.  

Over-the-Counter Status for Xyzal

Xyzal® (levocetirizine - Sanofi) was FDA approved for over-the-counter (OTC) status on Jan. 31, 2017. Expected to be available before the spring allergy season, the OTC product will be marketed as Xyzal® Allergy 24HR. Used to treat both seasonal and chronic allergies, it will be available as 5mg tablets that are indicated for adults, teens and children as young as six years old. A liquid form containing 0.5mg/mL may be used for children as young as two. One dose per day is taken in the evening.  

 
1Feb
From the CEO

From the CEO

Greetings and Welcome to February 2017! As you know, Open Season ended several months ago but the Foreign Service Benefit Plan (FSBP) continues to receive new enrollees and gain new members. Over 1500 new people chose to enroll in FSBP this year and we appreciate you trusting us with your health. These new members are seeking what our existing membership has enjoyed for many years – personalized service. The result is more phone calls to us, longer wait times and, in some unfortunate cases, the perception of diminished service. We apologize for any long wait times on the telephone. Your calls are important to us. We are adding more staff to continue offering the unparalleled service that our worldwide membership requires.

On another note, FSBP members will receive the IRS Form 1095-B by March 2, 2017, due to an extension from the original January 31st date granted by the IRS. This form confirms that you had minimal essential coverage while you were enrolled in FSBP in 2016. If you have questions about the IRS Form 1095-B, or about lost or incorrect forms, please contact us at 202-833-4910 or at [email protected]. Please do not contact OPM, your employing agency, or your retirement office, about IRS Form 1095-B. It is FSBP’s responsibility to make corrections to and answer questions about IRS Form 1095-B. Please note, the 1095-B form is not needed to file your tax return but it should be kept in your tax file for the year 2016.

In addition, Federal employees will receive the IRS Form 1095-C from your employing agency. It documents your agency offered you health coverage in 2016. If you have questions about the IRS Form 1095-C, or about lost or incorrect forms, you should call your agency using the phone number on Line 10 of the IRS form. Annuitants who were employed any portion of the year will receive an IRS Form 1095-C from their former employer. Otherwise, annuitants should not expect to receive this form. Click here for more information on IRS Form 1095-B and IRS Form 1095-C. Click here to visit the IRS website.

Lastly, February is American Heart Month. According to the American Heart Association, cardiovascular disease — including heart disease, stroke, and high blood pressure — is responsible for one out of every three deaths. It is the No. 1 killer of American women and men, and it is a leading cause of serious illness and disability. If you have high blood pressure, I encourage you to take steps to control it. Make sure to complete your routine physical examination, which FSBP covers at 100% when you visit an in-network provider or a provider outside the 50 United States. Monitoring your blood pressure is the best form of prevention.

We hope your family stays safe, warm, and healthy this winter. As always, thank you for your trust and for giving AFSPA the opportunity to serve you.

To Your Health,
Paula S. Jakub, RHU
CEO, AFSPA
Executive Director, Senior Living Foundation  

 
31Jan

Deadline to Claim 2016 Wellness Incentive(s)

To those members who participated in the Foreign Service Benefit Plan’s (FSBP) Simple Steps Living Well Together Program and Wellness Incentive in 2016, congratulations!  You took steps in making your wellness a priority.  However, some of you still have not claimed your $100 Wellness Incentive Reward(s) for completing one or more of the steps (Health Risk Assessment and Biometric Screening) outlined in the Living Well Together Program

You have only until March 6, 2017 to select and redeem your incentive(s).  After this date, you will not be able to redeem your incentive(s) for 2016.

To redeem your Wellness Incentive(s), please visit:

  • www.AFSPA.org/FSBP and select “My Online Services” (MOS) to log on to MOS
  • Select “Wellness Tools”
  • Select “WellBeing Solutions”
  • Click on the trophy in the upper right hand corner and select ‘My Rewards’

The $100 e-certificate incentive rewards you select when redeeming your incentives(s) will be emailed to you at the email address you provided during registration.

Please note the following change for the Simple Steps Living Well Together Program and Wellness Incentive for 2017:

Based on guidance from the Office of Personnel Management (OPM), we can no longer incent members with e-certificates that are not restricted to medical purchases.  As a result, when you complete one of the steps in our Living Well Together Program as outlined in the 2017 Plan Brochure, the FSBP will deposit money into a Wellness Incentive Fund Account.

The money deposited into your Wellness Incentive Fund Account is to help reimburse you for some medical costs, called “Eligible Medical Expenses”.  These include things like your deductible, coinsurance, and copayments that are your out-of-pocket expenses as outlined under Internal Revenue Service (IRS) Code Section 213(d).

 
31Jan
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

New Strength Approved for Narcan Nasal Spray

Narcan® (naloxone) Nasal Spray was approved by the U.S. Food and Drug Administration (FDA) in a 2mg dose on Jan. 25, 2017. Made by Adapt Pharma, it joins a 4mg strength that was launched in February 2016, for emergency treatment of known or suspected opioid overdose. The first dose should be given as soon as breathing difficulty or unconsciousness suggests that an overdose has been taken. Emergency help then should be contacted immediately. One spray (2mg) should be administered, in opposite nostrils, every two to three minutes until the patient recovers or emergency medical help arrives. To be packaged as two single-dose inhalers per box, Narcan Nasal Spray can be used for both adults and children. Complete prescribing information is available here.


Lower Strength Linzess Approved

On Jan. 26, 2017, Allergan and Ironwood Pharmaceuticals announced that their jointly marketed product, Linzess® (linaclotide) had been FDA approved as a new lower-strength. Like the 145mcg capsules, which were approved in 2012, the new 72mcg capsules are indicated to treat adults who have chronic idiopathic constipation (CIC). Over 30 million Americans are believed to have CIC, which has no apparent cause. Recommended dosing for CIC is one 72mcg or 145mcg capsule at least one-half hour before breakfast each day. A 290mg strength is approved for treating adults who have irritable bowel syndrome with constipation (IBS-C). A guanylate cyclase-C (GC-C) agonist, Linzess increases the amount of fluids in the intestines, speeds up movement of bowel contents and lessens abdominal pain. Due to the possibility that it may cause dehydration, Linzess should not be used for patients under the age of 18. The 72mcg strength is projected to be released in first quarter 2017. Updated prescribing information is available here.

 
27Jan

IRS Forms 1095-B and 1095-C

At the beginning of last year, Foreign Service Benefit Plan (FSBP) enrollees received the IRS Form 1095-B from the American Foreign Service Protective Association, underwriter for the FSBP, showing that you were covered under the FSBP.

You will receive the form again beginning in 2017 indicating that you had minimal essential coverage for the months in 2016 that you were enrolled in the FSBP.

If you have questions about the information on IRS Form 1095-B, or about lost or incorrect forms, you should contact us at (202) 833-4910 or at: [email protected]. Please do not contact OPM, your employing agency, or your retirement office about IRS Form 1095-B. OPM and the agencies will not be able to answer questions about the information on IRS Form 1095-B. It is our responsibility to make corrections to and answer questions about IRS Form 1095-B.

Federal employees also will receive the IRS Form 1095-C regarding their offer of health coverage from their employing agency. If you have questions about the information on IRS Form 1095-C, or about lost or incorrect forms, you should call your agency using the phone number provided on Line 10 of the IRS form. Annuitants who were employed a portion of the year will receive an IRS Form 1095-C also from your former employer. Otherwise, annuitants will not receive this form.

Click here for “Health Care Coverage Forms for Federal Employees Health Benefits – Fast Facts”.

Click here for “Health Care Coverage Forms for Annuitants – Fast Facts”.

 
27Jan

The governor of Georgia has declared a State of Emergency

The governor of Georgia has declared a State of Emergency impacting the following counties due to tornadoes:  Atkinson, Baker, Berrien, Brooks, Calhoun, Clay, Colquitt, Cook, Crisp, Dougherty, Lowndes, Mitchell, Thomas, Turner, Wilcox and Worth.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an emergency benefit override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide temporary alternate addresses (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed.

 
26Jan

Important Changes to Direct Billing Arrangements in China, Germany and Panama

AFSPA, underwriter for the Foreign Service Benefit Plan (FSBP), is reviewing and updating Agreements of Affiliation (AOA) with all of the international health care facilities in our Direct Billing Arrangements (DBA) to:

1) Confirm compliance with privacy regulations and
2) Confirm correct administrative and billing contacts.

Some China, Germany, and Panama agreements needed to be updated and will no longer be valid after February 28, 2017. Once a facility signs our updated AOA, we will add them back to our Direct Billing Arrangement.

Effective March 1, 2017, FSBP members will be required to pay out-of-pocket for services received from these facilities and submit a claim to the Plan. However, as an alternative, if a facility allows it, members can request a direct payment of benefits to the facility.  Members should submit a direct payment of benefits authorization for each claim filed by completing the bottom portion of our claim form, which can be downloaded at:

https://afspa.org/fsbp_home.cfm .

We will mail notifications to members when and if facilities sign updated AOA’s, reinstating the Direct Billing Arrangement.  In addition, we will post notices on our website and Facebook.

The facilities are listed below. 

 

Country

Cities

Facility Name

China

Beijing,Guangzhou, Shanghai

United Family Clinics (multiple locations)

  • Beijing United Family Hospital
  • Beijing United Family Rehabilitation Hospital
  • United Family CBD Clinic
  • United Family Financial Street Clinic
  • United Family Guancqumen Clinic
  • United Family Jianguomen Clinic
  • United Family Liangma Clinic
  • New Hope Clinic Center
  • United Family Shunyi Clinic and
  • United Family Wadaokou Clinic          
  • Guangzhou United Family Yue Xiu Clinic
  • Shanghai United Family Hospital           
  • Shanghai United Family Clinic                
  • Shanghai He Man Jia Clinic Co

Germany

Mainz

Universitätsklinik Mainz

Germany

Erlangen

Universitätsklinikum Erlangen

Germany

Frankfurt

Universitäts Klinikum Frankfurt Goethe-Universität

Germany

Darmstadt

Klinikum Darmstadt

Germany

Heidelberg

Universitätsklinikum Heidelberg

  • Frauenklinik Heidelberg                                 
  • Kinderklinik Heidelberg                      
  • Kopfklinik Heidelberg                          
  • Ludolf Krehlklinik

Germany

Mannheim

Theresienkrankenhaus und St. Hedwig-Klinik

Germany

Hanau

Klinikum Hanau

Germany

Berlin

Krankenhaus Waldfriede

Panama

Panama City

Hospital Punta Pacifica

Panama

Panama City

Hospital Nacional

Panama

Panama City

Hospital Santa Fe

 

 

 

 
23Jan
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

FDA Approval for Vantrela ER

Teva Pharmaceuticals Inc. announced on January 18, 2017, that it has received approval from the U.S. Food and Drug Administration (FDA) for Vantrela™ ER (hydrocodone) extended-release tablets. Vantrela ER, a CII scheduled opioid, is formulated to reduce the risk of abuse by ingestion, inhalation, and injection. It is indicated to treat intense pain that needs constant long-term drug treatment and that has not been controlled with other therapies. The tablets, which will be available in 15mg, 30mg, 45mg, 60mg and 90mg strengths, should not be chewed, crushed or dissolved. Recommended dosing is once every 12 hours with upper limits of 90mg per dose and 180mg per day. All opioids, including Vantrela ER, have several boxed warnings, including risks for abuse, addiction, overdose and respiratory depression. They caution about neonatal withdrawal syndrome for babies born to women who used opioids while pregnant, as well. Vantrela ER will be dispensed with a Medication Guide, under a Risk Evaluation and Mitigation Strategy (REMS). Teva has not yet announced its launch or pricing plans. Complete prescribing information is available here.  

Express Scripts is currently investigating the data around Vantrela ER for possible inclusion in the long-acting opioid step therapy rule.

Rhofade Approved to Treat Rosacea

Rhofade™ (oxymetazoline) cream 1% was FDA approved on January 18, 2017, for treating adults who have rosacea. Specifically, it is to be applied once a day to alleviate the facial erythema (redness) often caused by rosacea, a common chronic skin condition that causes acne, dryness and redness. Allergan plans to launch Rhofade in May 2017. Full prescribing information is available here

Express Scripts is currently investigating the data around Rhofade for a possible utilization management strategy.

FDA Approves Trulance for Chronic Constipation

On January 19, 2017, FDA approved Synergy Pharmaceutical’s Trulance™ (plecanatide) to treat adults who have chronic constipation without an apparent cause. Known as chronic idiopathic constipation (CIC), the condition is believed to affect as many as 33 million individuals in the United States. It is characterized by infrequent (three or less per week), incomplete and/or difficult bowel movements. Trulance stimulates an enzyme, guanylate cyclase-C (GC-C) that activates secretion of fluids in the gastrointestinal (GI) tract. One result is softer GI contents, which move through the intestines easier and faster. Taken once a day, Trulance will be available as 3mg tablets that can be crushed to mix with soft foods for those who cannot swallow whole tablets. Its labeling includes a boxed warning that children who take it may become seriously dehydrated. Thus, it is not indicated for patients under the age of 18 years. Launch is planned for later in the first quarter of 2017.


Fifth Indication for Imbruvica

AbbVie announced on Jan. 19, 2017, that FDA had granted accelerated approval, based on results from phase 2 studies, for Imbruvica® (ibrutinib) to treat relapsed or recurring marginal zone lymphoma (MZL). A form of non-Hodgkin’s lymphoma, MZL is estimated to affect fewer than 1,000 Americans, mostly older adults. Eligible patients will need to have systemic treatment and they previously have been treated with an anti-CD20 drug, such as Rituxan® (rituximab – Biogen / Genentech). An oral Bruton’s tyrosine kinase inhibitor, Imbruvica also is approved for treating certain patients with chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), small lymphocytic lymphoma (SLL) and Waldenström’s macroglobulinemia (WM). It is supplied as 140mg oral capsules. Depending on the condition being treated either three capsules (420mg) or four capsules (560mg) are taken once a day. Full prescribing information for Imbruvica is available here

Atopic Dermatitis Issues Document Available

Atopic dermatitis (AD), a form of eczema, is an inflammatory skin disease that affects approximately 10% to 20% of children and 1% to 3% of adults. AD presents as itchy and dry skin which can lead to lichenification (leathery skin) and lesions. Incidence of AD is highest in infancy with 60% of cases occurring within the first year of life, and 90% within the first five years of life. The strongest risk factor for AD is a family history for atopic (allergic)diseases such as AD, asthma and allergic rhinitis. Currently, moisturizers are an important part of treatment. Established medications for AD include topical corticosteroids, followed by topical calcineurin inhibitors (i.e., Elidel® [pimecrolimus 1% cream], Protopic® [tacrolimus 0.03% and 0.1% ointment, generic]). Short-term phototherapy and systemic immunosuppressive therapy (e.g., cyclosporine, azathioprine, methotrexate) is recommended if flares cannot be adequately controlled. The approval of topical Eucrisa™ (crisaborole ointment, 2% – Pfizer) in December 2016 and the anticipated approval of Dupixent (dupilumab subcutaneous injection – Regeneron / Sanofi) in March of 2017 provide newer therapy options. The intent of this Issues Document is to describe medicines in the atopic dermatitis market and to recognize that Express Scripts is evaluating potential utilization management programs for newer AD therapies. The Issues document is available here

 
19Jan
Message from the COO

Message from the COO

To Our Valued Members,

We have been experiencing a high call volume in recent days, particularly for the Foreign Service Benefit Plan. Many of our new members are reaching out with questions regarding their benefits and the programs we offer. I apologize for the long wait times and delays in service.

To be transparent, AFSPA is going through growing pains. We added nearly 2000 members in a two month period. This has created additional challenges in managing the increased amount of calls. The phone system provides you with an estimated wait time, and I understand many have experienced longer waits that estimated. In response to these challenges, we have increased the number of staff answering member calls. Our goal has been to offer “unparalleled service” to all members. But with the recent growth, we have fallen short of this in some instances, and for that, I am personally and truly sorry.

Many of our newly enrolled members are still waiting for their ID cards to arrive. Our ability to send the cards depends on when we receive enrollment paperwork from the Federal payroll offices, and more than a month after the end of Open Season we continue to receive paperwork. We make every effort to process enrollments and changes as quickly as possible, and Aetna mails cards to members within two weeks after receiving the enrollment information.   

For current members seeking information on the status of claims, I encourage you to visit My Online Services at https://member.cvty.com. If you have other questions or are a new member, you can call us at 202-833-4910 or use the links to secure forms on our website at www.afspa.org/secureforms.cfm. Answer two or three questions and you will be at the right form. These forms are tracked through a ticket system in our office, and multiple people have access to the forms. This ensures that your message will not get lost or delayed because someone is out of the office. The increased membership has affected our response time to written correspondence as well, but we strive to provide timely responses to all inquiries.

Please note that our office will be closed on Friday, January 20, 2017, due to activities related to the Presidential Inauguration. We will resume normal business hours on Monday, January 23, 2017, at 8:30 am.

I encourage you to let us know how we can serve you better. Assisting our members and improving the member experience is our first priority. Thank you for trusting us with your care.

 

Sincerely,

Kyle Longton

Chief Operating Officer

 
17Jan
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Arymo ER Abuse-Deterrent Morphine Approved

On January 9, 2017, the U.S. Food and Drug Administration (FDA) approved Arymo™ ER (morphine sulfate) extended release. A C-II scheduled drug, it is indicated for managing severe pain that needs constant treatment and that is not controlled by other treatments. The manufacturer, Egalet Corp., plans to launch Arymo ER during the first quarter of 2017. It will be available as 15mg, 30mg and 60mg extended-release tablets that are designed to resist abuse. The polymer-matrix tablets are difficult to break or crush, and they congeal when exposed to liquids. Even so, Arymo ER has the same boxed warning that is on all opioids -- that taking it may be associated with abuse, addiction, misuse, overdose and death. Babies born to women who use it during pregnancy may suffer neonatal withdrawal syndrome and older children may overdose from accidentally taking it. Recommended dosing for patients new to opioid therapy is one 15mg tablet every 8 hours to 12 hours. Full prescribing information for Arymo ER is available here.

 
13Jan

The governor of Oklahoma has declared a State of Emergency

The governor of Oklahoma has declared a State of Emergency impacting all counties in Oklahoma due to Winter Storm Jupiter.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an emergency benefit override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide temporary alternate addresses (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed.

 

 
10Jan

The governor of Nevada has declared a state of Emergency

The governor of Nevada has declared a State of Emergency for the following counties due to severe flooding: Douglas, Lyon, Storey, Washoe and the City of Carson City with an effective date of January 9, 2017 and expiration date of February 8, 2017.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an emergency benefit override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide temporary alternate addresses (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed.

 
10Jan
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Generic to Emend Capsules Launched

On January 4, 2017, Sandoz announced the launch of its AB-rated generic to Merck’s Emend® (aprepitant capsules), a product indicated for use in combination with other antiemetic agents, in patients 12 years of age and older, for the prevention of acute and delayed nausea and vomiting associated with chemotherapy. It is also approved for the prevention of postoperative nausea and vomiting in adults. Sandoz’ generic is available as 40mg, 80mg, and 125mg capsules. U.S. sales of Emend capsules were approximately $62 million for the twelve months ending October 2016. Shipments of the generics have already begun.

Generic to Kaletra Oral Solution Approved

On January 3, 2017, Lannett Company announced that it received U.S. Food and Drug Administration (FDA) approval for its AB-rated generic to AbbVie’s Kaletra® (lopinavir/ritonavir oral solution), 80mg/20mg per mL. Kaletra is an HIV-1 protease inhibitor indicated for use in combination with other antiretrovirals for the treatment of HIV-1 infection in adults and children (14 days and older). The oral solution must be taken with food. Generics to AbbVie’s Kaletra capsules and tablets have not yet been approved. Lannett plans on launching its generic lopinavir/ritonavir oral solution in the near future.

Lucentis Approved for Myopic Choroidal Neovascularization

Genentech announced the FDA approval of Lucentis® (ranibizumab injection) 0.5mg for the treatment of patients with myopic choroidal neovascularization (mCNV) on January 5, 2017. This condition is a complication of severe near-sightedness that can lead to blindness. Recommended dosing for mCNV is 0.5mg (0.05mL) by intravitreal (eye) injection once monthly for up to three months. Lucentis is a vascular endothelial growth factor (VEGF) inhibitor that was first approved in 2006 for treating diabetic macular edema (DME). It is also approved to treat wet age-related macular degeneration, macular degeneration due to obstructed retinal veins and DME in patients who have diabetic retinopathy. Full prescribing information is available here

FDA Approvals for 2016 Issues Document Available

In 2016, the Food and Drug Administration (FDA) approved 24 new medications, known as new molecular entities (NMEs) and therapeutic Biologic License Applications (BLAs), which is significantly lower that the all-time high of 56 new medications approved in 2015. This document is intended to provide a brief overview of FDA’s approval activity for 2016. The “FDA Approvals for 2016” Issues Document is available here

 
9Jan

State of Emergency in Georgia, North Carolina, South Carolina and Virginia

The Governor of Georgia has declared a State of Emergency for the following counties due to Winter Storm Helena: Baldwin, Banks, Barrow, Bartow, Bibb, Butts, Carroll, Catoosa, Chattooga, Cherokee, Clarke, Clayton, Cobb, Columbia, Coweta, Crawford, Dade, Dawson, DeKalb, Douglas, Elbert, Fannin, Fayette, Floyd, Forsyth, Franklin, Fulton, Gilmer, Gordon, Greene, Gwinnett, Habersham, Hall, Hancock, Haralson, Harris, Hart, Heard, Henry, Jackson, Jasper, Jones, Lamar, Lincoln, Lumpkin, Madison, McDuffie, Meriwether, Monroe, Morgan, Murray, Muscogee, Newton, Oconee, Oglethorpe, Paulding, Pickens, Pike, Polk, Putnam, Rabun, Richmond, Rockdale, Spalding, Stephens, Talbot, Taliaferro, Taylor, Towns, Treutlen, Troup, Union, Upson, Walker, Walton, Warren, White, Whitfield and Wilkes.

The Governors of North Carolina, South Carolina and Virginia have declared States of Emergency due to Winter Storm Helena impacting all counties in each state.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an emergency benefit override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide temporary alternate addresses (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed.

 
4Jan
From the CEO

From the CEO

Happy New Year and Welcome to 2017! We want to welcome all our newly enrolled Foreign Service Benefit Plan (FSBP) members. It is an honor to be your chosen health plan. We are offering many new services to start your new year off in the right direction. Please take the time to review your full Plan brochure. However, I wanted to tell you about a few featured benefits in this first monthly message of the year.

Telehealth is an important new 2017 benefit for our members. It provides 24/7, on demand access to medical professionals via phone, mobile, and video. Unlike the Nurseline, which remains an important benefit, our Telehealth benefit provides for a virtual visit with a provider. Doctors can treat and prescribe medications for common health issues such as: colds, flu, fever, rash, ear infections, and migraines. You even can “see” a therapist for ongoing counseling. We provide this progressive delivery system with no cost to you - yes, you have a $0.00 copay for using the Telehealth program.  I recommend you register now, before you get sick, so that your medical information and history is available already to the Telehealth providers. Then, the service will be there for you when you need it. Click here to sign up today, or call 844-733-3627 (844-SEE-DOCS). To learn more about our telehealth vendor, American Well (Amwell), click here. Please note: Until programming of Amwell’s site is completed, you will have to use a code when you use Amwell, so you will not be charged for the service. We are mailing the code to all Foreign Service Benefit Plan (FSBP) Benefit Plan members in a letter shortly. If you have signed up to receive e-mail communications from us, the code is in the e-mail we are sending you in a few days. If you have not signed up to receive e-mail communications, you may do so for future emails through our Member Portal at https://secure.myafspa.org/. We encourage you to do this so that we can keep in touch.

Many people make resolutions to improve their health at the start of a new year. This may include quitting smoking, losing weight, or developing a regular exercise routine. In 2017, let FSBP assist you with your goals. We have many programs that fit your individual needs. Utilize the Mediterranean Wellness Program, an eight-week interactive online program, to reach your fitness and nutrition goals. Health Coaching sets you up with a one-on-one health coach to help you make and reach your health goals regarding stress management, tobacco cessation, nutrition, exercise plans, and more. Click here to see a full list of Healthy Actions that are available to you. Don’t forget the discounts you receive on Weight Watchers and Jawbone Fitness Trackers just for being an FSBP member. Click here and go to the Non-FEHB Programs tab for more information on all our discount programs.

Now that the holiday season has ended, please use your massage therapy benefits to relieve any additional stress. No medical referral is required. FSBP covers 40 visits per year, up to $60 per visit. That is over three massages a month. January is a great time to get started.

I wish you a prosperous and healthy New Year. As always, thank you for your trust and for giving us the opportunity to serve you.

To Your Health,

Paula S. Jakub, RHU
CEO, AFSPA
Executive Director, Senior Living Foundation

 
4Jan
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

New Indications for Adynovate

Shire’s Adynovate® (antihemophilic factor [recombinant], PEGylated), a long-acting factor VIII product originally  approved by the U.S. Food and Drug Administration (FDA) in November 2015, gained  two additional indications on Dec. 27, 2016. Initially indicated to treat bleeding episodes and to reduce the frequency of bleeds for patients with hemophilia A who are 12 years of age and older, Adynovate is now also approved for use by patients younger than 12 years. Additionally, it received FDA approval for use to control bleeding for patients with hemophilia A of any age during surgery. Adynovate can be injected as needed to manage bleeding episodes. To prevent bleeds, it is given intravenously (IV) on a twice-weekly schedule with dosing based on the patient’s weight. Full prescribing information is available here.

 
28Dec
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Pediatric Indication for Tresiba

On December 16, 2016, Novo Nordisk’s Tresiba® (insulin degludec) received approval from the U.S. Food and Drug Administration (FDA) for an expanded indication. Tresiba now can be used to improve glycemic (blood sugar) control for teens and children as young as one year old. It is approved for patients with either type 1 or type 2 diabetes. A basal (long-acting) insulin that is injected once daily, it is available in both 100 units/mL (U-100) and 200 units/mL (U-200) FlexTouch® insulin pen delivery devices. Each disposable pen is prefilled with 3mL of Tresiba. Doses up to 80 units (of U-100) or 160 units (U-200) may be given in one injection. However, it should not be used for patients whose doses are 5 units or less. A new pen needle should be used for each injection and each insulin pen should be used by only one person, even after the needles are changed. Click here for Tresiba’s full prescribing information.

Spinraza Approved to Treat Spinal Muscular Atrophy

Spinraza™ (nusinersen) was approved by the U.S. Food and Drug Administration (FDA) on December 23, 2016. It is the first drug indicated to treat spinal muscular atrophy (SMA), a rare genetic condition that causes increasing weakness in muscles. Spinraza will be given intrathecally (directly into the fluid around the spinal cord) by a healthcare provider who is trained to perform spinal procedures. Recommended dosing is three 12mg doses administered at two-week intervals, followed by a fourth dose one month after the third; and then by one dose every four months. Ionis Pharmaceuticals developed Spinraza, which will be marketed by Biogen, Inc. Launch is expected this week. It will be available exclusively through Accredo Specialty Pharmacy and CuraScript Specialty Distribution. For complete prescribing information click here

 
28Dec
Express Scripts News Flash

Express Scripts News Flash

Rubraca Approved for Ovarian Cancer

The U.S. Food and Drug Administration (FDA) granted accelerated approval for Rubraca™ (rucaparib – Clovis Oncology, Inc.) on Dec. 19, 2016. It is indicated for ovarian cancer that has progressed despite at least two chemotherapy treatments and that has a deleterious BRAC genetic mutation as confirmed by an FDA-approved diagnostic test. Accelerated approval is given for drugs with clinical study information showing promise for treating serious or life-threatening diseases, even though studies are not completed. Rubraca is an oral drug with recommended dosing of 600mg twice a day until the cancer worsens or the patient cannot take the drug any longer. Clovis Oncology plans on launching Rubraca as soon as possible. It will be available through a limited network of specialty pharmacies that doesn’t include Accredo. Prescribing information is available here

  • Brand (Generic) Name: Rubraca™ (rucaparib)
  • Manufacturer: Clovis Oncology, Inc.
  • Date Approved: December 19, 2016
  • Indication: Monotherapy for advanced ovarian cancer that has been treated two or more times with chemotherapy and that has BRAC deletions as verified by FDA-approved companion diagnostic testing
  • Dosage Forms Available:  200mg and 300mg tablets
  • Launch Date: Launch date for Rubraca is not known at this time; however, Clovis plans on bringing it to market “as quickly as possible”.
  • Estimated Annual Cost: Pricing information is not yet available
  • Specialty Status:  Rubraca will be added to Express Scripts’ specialty drug list.
  • According to the National Cancer Institute, approximately 22,000 cases of ovarian cancer are diagnosed each year in the U.S. Between 15% and 29% of ovarian cancers have BRAC mutations.
  • Rubraca is a poly ADP-ribose polymerase (PARP) inhibitor that destroys cancer cells or limits their growth by interfering with DNA repair.
  • In clinical trials, tumors shrank at least partially for over one-half of patients receiving Rubraca. Response lasted a little over nine months, on average.

FDA also approved the FoundationFocus™ CDxBRCA™ companion diagnostic made by Foundation Medicine, Inc. for use with Rubraca.

 
20Dec
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Synjardy XR Approved

Eli Lilly and Boehringer Ingelheim announced on December 12, 2016, that the U.S. Food and Drug Administration (FDA) had approved their jointly-marketed, long-acting combination, Synjardy® XR (empagliflozin/metformin extended-release) tablets. It is taken once daily to improve glycemic (blood sugar) control for adults with type 2 diabetes mellitus when treatment with both empagliflozin and metformin is appropriate. Empagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor, a drug class that blocks reabsorption of glucose in the kidneys. Metformin lowers glucose production and raises insulin utilization. As with all drug products that include metformin, Synjardy XR carries a boxed warning and has a medication guide about the possibility that it may cause lactic acidosis -- a rare, but potentially dangerous, accumulation of acids in the body. Launch date and pricing have not been announced. Complete prescribing information is available here.

Restylane Refyne and Restylane Defyne Dermal Fillers Approved

On December 12, 2016, Galderma announced the FDA approval of Restylane® (Refyne) and Restylane® (Defyne) for the treatment of nasolabial folds or “laugh lines” in patients over 21 years of age. Restylane Refyne is approved to treat moderate to severe facial wrinkles and folds while Restylane Defyne is approved to treat moderate to severe, deep facial wrinkles and folds. These Restylane products are next-generation hyaluronic acid dermal fillers. Several other Restylane products are currently available on the market. Additional information is available here.

Mylan Launches an EpiPen Authorized Generic

Mylan announced the launch of an authorized generic (AG) to EpiPen® (epinephrine injection) auto-injector, a product indicated for the emergency treatment of severe allergic reactions, including anaphylaxis. An AG is the brand product in generic-looking packaging. According to Mylan, the wholesale acquisition cost (WAC) for the AG is $300 for a two-pack of epinephrine auto-injectors. It is available in 0.15 mg and 0.3 mg strengths and should be in retail pharmacies beginning next week. In 2015, U.S. annual sales for EpiPen were approximately $1.7 billion.

Basaglar Now Available

Lilly and Boehringer Ingelheim’s Basaglar® (insulin glargine), the first follow-on to Sanofi’s Lantus® (insulin glargine) was launched in the U.S. on December 15, 2016. It is a long-acting insulin indicated to improve glycemic control for adult and pediatric patients with type 1 diabetes, and for adults with type 2 diabetes. It is supplied in cartons of five KwikPen® devices that each contain 3mL of U-100 (100 units per mL) of Basaglar. Recommended dosing is individualized according to the patient’s blood glucose levels. Basaglar is given as one subcutaneous injection daily at about the same time of day.  Basaglar Wholesale Acquisition Cost (WAC) is $316.85 for a pack of five pens. Additional competition within the long-acting insulin market should help alleviate some of the price increases common to this category.  Full prescribing information is available here.

MedWatch Update

Pioglitazone

After analyzing additional information from post-marketing studies, FDA has reaffirmed a previous warning for the oral diabetes drug, pioglitazone. In 2010 and 2011, interim study data suggested that taking pioglitazone could be associated with an increased incidence of bladder cancer. Although more recent results are mixed, further study shows that a relationship between pioglitazone use and a slightly higher risk of bladder cancer is more likely; especially for patients on long-term therapy. Pioglitazone is a thiazolidinedione that works by helping body tissues use insulin more efficiently. In the U.S., it is sold as generics, as the brand name, Actos® (Takeda), and in four combination drugs, which also are made by Takeda: Actoplus Met® (pioglitazone/metformin), Actoplus Met® XR (pioglitazone/metformin extended-release), Duetact® (pioglitazone/glimepiride) and Oseni (pioglitazone/alogliptin). More information on the warning is available here.  

 
15Dec
Clinical Matters News Flash

Clinical Matters News Flash

Eucrisa Approved for Atopic Dermatitis

On December 14, 2016, the U.S. Food and Drug Administration (FDA) approved Pfizer’s Eucrisa™ (crisaborole) ointment, 2%. It is the first topical phosphodiesterase 4 (PDE-4) inhibitor indicated to treat eczema (chronic inflammatory skin conditions) in patients two years of age and older. Atopic dermatitis is a common form of eczema. Eucrisa is applied as a thin coating on the affected skin twice a day. Full prescribing information is available here.

  • Brand (Generic) Name: Eucrisa™ (crisaborole)
  • Manufacturer: Pfizer
  • Date Approved: Dec. 14, 2016
  • Indication: Topical treatment of mild-to-moderate eczema for patients at least two years of age
  • Dosage Forms Available: 2% ointment in 60Gm and 100Gm tubes
  • Launch Date: Early 2017
  • Estimated Cost: A 60Gm tube will retail for $580.
  • Eczema is a group of chronic skin diseases that involve inflammation and cause itchy, irritated bumps, crusts and scales on the skin. It usually begins in childhood, with most patients having a first episode before the age of five. Symptoms may improve and worsen unpredictably. Inflammation and scratching eventually can thicken and toughen the skin.
  • According to the National Eczema Association, about 11% of American children have eczema and most will continue to have symptoms into adulthood.
  • Eucrisa reduces the activity of phosphodiesterase 4 (PDE-4) to decrease inflammation.
  • In clinical studies, eczema cleared or almost cleared for about one-third of patients using Eucrisa. Only between one-fifth and one-fourth of patients using the identical ointment base with no active ingredients in it had significant symptom improvement. Study participants used the products for 28 days.
  • Side effects from Eucrisa include pain and stinging at the site of application.
  • Eucrisa will compete with current topical drug treatments for eczema; including topical steroids, such as betamethasone and fluocinolone, and calcineurin inhibitors, such as Elidel® (pimecrolimus).
 
13Dec
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Jardiance Receives Cardiovascular Indication

Eli Lilly and Boehringer Ingelheim announced on December 2, 2016, that their jointly-marketed diabetes drug, Jardiance® (empagliflozin) has a new indication from the U.S. Food and Drug Administration (FDA). It is the first diabetes drug indicated to decrease the risk of cardiovascular (CV)-related deaths for adults who have both type 2 diabetes and CV disease. Diabetes patients are more likely to have CV disease than individuals without diabetes. In the EMPA-REG OUTCOME® study, fewer patients who took Jardiance along with their usual diabetes and CV drugs died from heart attacks or strokes than patients who took standard drugs with a placebo. Jardiance is a sodium-glucose co-transporter 2 (SGLT2) inhibitor, a class of drugs that lowers blood sugar by blocking its absorption in the kidneys and forcing more to be eliminated in the urine. It was first FDA approved in August 2014 as combination therapy with lifestyle changes to improve glycemic control for adults who have type 2 diabetes. Recommended dosing for Jardiance is one tablet (either 10mg or 25mg) every morning. Its complete prescribing information is available here.

Generic Available for Latisse

Sandoz launched a generic for Latisse® (bimatoprost ophthalmic solution, 0.03% -- Allergan) on December 7, 2016. Bimatoprost is a prostaglandin that is indicated to treat hypotrichosis (thinning) of the upper eyelashes. When applied regularly to the base of the eyelashes on each upper eyelid, it darkens, lengthens and thickens lashes. Dosing is one drop to each upper eyelash every evening applied with disposable, single-use applicators that are dispensed with the solution. Available sizes are 3mL in a 4mL bottle (with 70 applicators) and 5mL in an 8mL bottle (with 140 applicators). Treated eyelids may darken, itch or swell and the colored parts of the eyes may darken, often irreversibly, as well. As estimated by IMS Health, sales for Latisse amounted to $75 million in the U.S. during the 12-month period that ended on October 31, 2016.

New Indication for Avastin

On December 6, 2016, FDA approved Genentech’s Avastin® (bevacizumab) as treatment for patients with epithelial ovarian, fallopian tube or primary peritoneal cancers that return six months or longer after being treated with a platinum-based therapy. For such platinum-sensitive cancers, Avastin will be used in addition to chemotherapy with carboplatin and either gemcitabine or paclitaxel. In clinical trials, progression-free survival (PFS) was about four months longer for participants who used Avastin along with chemotherapy as compared to those using only chemotherapy. Avastin is a monoclonal antibody that blocks vascular endothelial growth factor (VEGF), a protein that helps tumors grow and spread. It has been granted several additional indications, including one for treating platinum-sensitive cancers that recur within six months after platinum chemotherapy ends, since its original FDA approval in 2004. To treat platinum-sensitive cancers, Avastin is given in combination with the other drugs as an intravenous (IV) infusion once every three weeks for at least six cycles. If used with carboplatin and paclitaxel, up to two additional combination cycles may be given; if used with carboplatin and gemcitabine, up to four more combination cycles may be used. After the last combination-therapy cycle, Avastin is then given alone once every three weeks. Dosing is 15mg per Kg of body weight. A boxed warning cautions that Avastin may cause hemorrhaging, punctures in the gastrointestinal (GI) tract or complications with wound healing. Because it may interfere with healing, using it should be stopped 28 days or longer before planned surgery and not resumed until after the surgical incision is totally healed (at least 28 days after the procedure). Full prescribing information may be found here.  

Generic to Zetia Launched

On December 12, 2016 Par Pharmaceuticals announced the launch of its AB-rated generic to Merck’s Zetia® (ezetimibe), a drug approved to reduce elevated LDL cholesterol (LDL-C) in patients with hyperlipidemia. Available dosing is 10 mg tablets. As estimated by IMS Health, sales for Merck’s Zetia® (ezetimibe) amounted to $2.6 billion in the U.S. for the most recent twelve months ending in Sept. 2016.  The company was also granted 180 days of generic exclusivity, preventing FDA from approving additional generics until June 2017. Vytorin® (ezetimibe/simvastatin – Merck) will lose patent protection on Apr. 25, 2017. Several manufacturers are expected to launch once this patent expires. According to IMS Health, this product had approximately $714 million in U.S. sales in 2015.     

Generic Approved for Tamiflu

On December 12, 2016 Alvogen, the U.S. partner of Natco Pharma, announced that it has introduced the first generic for Tamiflu® (oseltamivir - Genentech) to the American market. Oseltamivir is a neuraminidase inhibitor approved by the U.S. Food and Drug Administration (FDA) to treat and prevent influenza A and influenza B under specific circumstances. Available dosage forms are 30mg, 45mg and 75mg capsules. Recommended dosing is one capsule twice a day for five days or 10 days, but some patients take it for up to 12 weeks, depending on the indication and the patient.  Oseltamivir does not replace the need for an annual influenza vaccination.  For adults, starting oseltamivir within 48 hours from the onset of flu symptoms reduced the duration of symptoms by about one-third (from an average of approximately 103 hours to around 72 hours).  According to IMS Health, 2015 U.S. sales for Tamiflu were about $403 million.  FiercePharma reports that Alvogen will have 180 days of exclusivity before other companies can launch additional generics.

 
13Dec

FEDVIP Open Season Extension

OPM has announced that it has extended the opportunity to make FEDVIP dental and vision enrollments/change/cancellations until midnight on Wednesday, December 14, 2016.

The dental and vision enrollment website, BENEFEDS.com, is currently undergoing repairs due to technical issues, however, the call center (1-877-888-3337) is open until midnight on Wednesday, December 14, 2016, Eastern Time to process FEDVIP changes.  Those wishing to enroll or make changes can do so by calling the call center. 

 

 
5Dec
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Veltassa Labeling Change

Veltassa® (patiromer) is a potassium-trapping drug used to reduce hyperkalemia (high blood levels of potassium) -- primarily for patients with chronic kidney disease or heart failure. It was approved by the U.S. Food and Drug Administration (FDA) in October 2015. Its labeling included a boxed warning about its possible interactions with other oral drugs and directions to separate taking it by at least six hours from other drugs. After further testing, FDA is allowing Veltassa’s manufacturer, Relypsa, to delete the boxed warning, to move interactions information to other parts of the label and to change the interval between taking Veltassa and other drugs to three hours. Recommended dosing is one packet (containing 8.4 Gm, 16.8 Gm or 25.2 Gm of Veltassa) dissolved in at least one-third cup of water. Patients drink the Veltassa mixture along with food, but it should not be heated or mixed into hot liquids. Prescribing information is available here.

Full FDA Approval for Iclusig

FDA accelerates approval for some drugs that appear promising in mid-stage clinical trial data to treat patients who have serious conditions that are not controlled by existing therapies. The tyrosine kinase inhibitor (TKI), Iclusig® (ponatinib – Ariad Pharmaceuticals, Inc.), was granted an accelerated approval on December 14, 2012, after it showed effectiveness in phase II trials of patients with two rare types of leukemia. Based on the results of continuing studies, FDA gave it full approval for treating both conditions on November 28, 2016. Iclusig treats adults who have no other TKI therapy options for either chronic phase, blast phase or accelerated phase chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). It also is indicated for CML or Ph+ ALL that is T315I-positive -- a specific kind of mutation that resists treatment with some other TKIs. Approximately one-third of clinical trial participants using Iclusig experienced some degree, including some fatal events, of artery blockages while taking the drug. Smaller numbers of participants developed venous thromboembolisms (blood clots in the veins), heart failure or liver damage. Iclusig’s label has a boxed warning about all of these potentially severe side effects. It is an oral drug with recommended initial dosing of 45mg once a day. However, doses frequently are lessened to 30mg or 15mg per day depending on the patient’s condition, response and side effects. Complete Iclusig prescribing information is available here.

 

 
1Dec
From the CEO

From the CEO

To our Valued Members,

As 2016 comes to a close, I find myself thinking about the past year, and looking forward to the new year. I am grateful to our American Foreign Service Protective Association (AFSPA) members. I also am grateful to the AFSPA employees who provide you with the level of service you expect. We hope to continue our strong relationship with you in 2017.

I want to remind you that Open Season ends on December 12. You have a few days left to review your options carefully and make changes to your Federal Employee Health Benefit (FEHB) Program enrollment, your Federal Employees Dental and Vision Insurance Program (FEDVIP) enrollment, and your FSAFEDS enrollment. Please consider AFSPA’s many services when making these important decisions.

On another note, we encourage you to wear a red ribbon this month to show support to the millions of people living with HIV. December 1 marks World AIDS Day. This annual day of reflection is an opportunity for people worldwide to unite in the fight against HIV. There still is a vital need to increase awareness, fight prejudice, and improve education. The Foreign Service Benefit Plan (FSBP) covers HIV screening and counseling at 100% when you visit an in-network provider. It is important to get tested regularly and to know your status.

Finally, this time of year is a time to make positive lifestyle changes. Focus on a balance of food and activity this holiday season. Incorporate healthier recipes in your meals and don’t forget to exercise. You also can take advantage of FSBP’s “Simple Steps to Living Well Together” Program which can help you identify your health risks and assist in achieving your health goals.   

As always, our mission is to provide you with “unparalleled service.” It is our pleasure to serve you and we thank you for entrusting us with your healthcare needs. I wish you and your loved ones a wonderful and healthy holiday season.

 

To Your Health,

Paula S. Jakub, RHU

CEO, AFSPA

Executive Director, Senior Living Foundation

 
1Dec
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Expanded Indication for Darzalex

On November 21, 2016, The U.S. Food and Drug Administration approved two drug regimens that include Janssen Biotech’s Darzalex® (daratumumab) injection for intravenous use. For treating patients who have multiple myeloma that has been treated once previously, Darzalex now is indicated along with dexamethasone and Revlimid® (lenalidomide – Celgene Corporation) or Velcade® (bortezomib – Millennium Pharmaceuticals). Darzalex is a monoclonal antibody with specific activity against CD38, a protein on the surface of multiple myeloma cells. Originally, Darzalex was FDA approved in November 2015 to be used by itself after multiple-myeloma patients had tried at least three other treatments, including an immunomodulator, such as Revlimid, and a proteasome inhibitor, such as Velcade. For use with Revlimid, the recommended dosing schedule for Darzalex is once a week for eight weeks, then once every two weeks until week 24 and then once every four weeks. With Velcade, the schedule is Darzalex once every week for nine weeks, once every three weeks between weeks 10 and 24 and then once every four weeks. Darzalex continues to be administered by a healthcare provider until it stops working. Although infusion rates may vary, the recommended dose for all Darzalex indications is 16mg/Kg of the patient’s body weight. Complete prescribing information is available here.  
Quadrivalent FluLaval Approved for Young Children

FluLaval® Quadrivalent, an inactivated influenza (flu) vaccine made by GlaxoSmithKline, has been FDA approved for vaccinating children between the ages of six months and three years. The vaccine, which contains two strains of influenza A virus and two strains of influenza B, received its first U.S. approval in 2013 for adults and children three years of age and older. The recommended dose, 0.5mL injected intramuscularly (IM), is the same for all age groups. For infants, toddlers and children through age eight years, who have never had a flu vaccine; the most common dose schedule is two injections given at least one month apart. Children who have been previously vaccinated, and all individuals who are nine years and older, only require one shot per year. Updated prescribing information is available here.  

 
30Nov
Clinical Matters News Flash

Clinical Matters News Flash

Soliqua and Xultophy Approved for Type 2 Diabetes

The U.S. Food and Drug Administration (FDA) simultaneously approved Sanofi’s and Novo Nordisk’s fixed-dose long-acting insulin and glucagon-like peptide 1 (GLP-1) agonist combination products for treating type 2 diabetes. Soliqua™, from Sanofi, is a fixed dose combination product of Lantus® (insulin glargine) and Adlyxin® (lixisenatide). Novo Nordisk’s Xultophy® combines the company’s Tresiba® (insulin degludec) and Victoza® (liraglutide). Both products are dosed once-daily by subcutaneous injection. Soliqua will be available in U.S. retail pharmacies in January 2017 while Xultophy’s launch will occur in the first half of 2017.

Soliqua prescribing information can be found here.

Xultophy prescribing information can be found here.

  • Brand (Generic) Name:
    • Soliqua™ (insulin glargine & lixisenatide injection - Sanofi)
    • Xultophy® (insulin degludec & liraglutide injection - Novo Nordisk)
  • Date Approved: November 21, 2016
  • Indication: Treatment of adults with type 2 diabetes inadequately controlled on basal insulin or GLP-1 agonists as monotherapy.
  • Dosage Forms Available:
    • Soliqua: 100 units of Lantus (insulin glargine) per mL and 33 mcg of Adlyxin (lixisenatide) per mL in a 3 mL single-patient-use pen.
    • Xultophy: 100 units of Tresiba (insulin degludec) per mL and 3.6 mg of Victoza (liraglutide) per mL in a 3 mL single-patient-use pen.
  • Launch Date: Soliqua will be available in U.S. retail pharmacies in January 2017. Xultophy will launch sometime in the first half of 2017.
  • Estimated Annual Cost: Pricing information is not available at this time.
  • Type 2 diabetes is the most common form of the disease affecting about 29 million people in the US; it accounts for more than 90% of diabetes cases.
  • Sanofi estimates that approximately half of patients, or 4 million Americans, treated with basal insulins are not at the American Diabetes Association's HbA1c goal of <7%. Many of these patients may be candidates for the long-acting insulin/GLP-1 agonist combination products.
  • Implications:  Express Scripts is currently investigating the data around Soliqua and Xultophy for a possible utilization management strategy.
 
30Nov
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Bonjesta Approved to Treat Nausea and Vomiting of Pregnancy

Duchesnay, Inc. received U.S. Food and Drug Administration (FDA) approval on November 7, 2016, for Bonjesta (doxylamine/pyridoxine) extended-release tablets. Bonjesta combines 20mg each of an antihistamine (doxylamine) and a form of vitamin B6 (pyridoxine). It is indicated to treat nausea and vomiting associated with pregnancy when conservative treatment, such as dietary modification, is not effective. If the recommended dose of one tablet at bedtime does not control symptoms, an additional tablet may be added in the morning. No more than two tablets should be taken per day and they should be swallowed whole with a full glass of water but no food. Bonjesta may cause sleepiness. It has not been tested among patients who are under the age of 18 years or who have hyperemesis gravidarum, a serious condition that may need hospitalization. Duchesnay also manufactures Diclegis® (doxylamine/pyridoxine) delayed-release tablets, which was FDA approved in April 2013. Also indicated for pregnancy-related nausea and vomiting, Diclegis contains 10mg of each ingredient in Bonjesta. Although Bonjesta’s launch and pricing plans are not yet public, its prescribing information is available here.   

 

 

Express Scripts is currently investigating the data around Bonjesta for a possible utilization management strategy.

 

 

First Prescription Prasterone Approved

On November 17, 2016, FDA announced that it approved EndoCeutics’ Intrarosa™ (prasterone) vaginal inserts to treat vulvovaginal atrophy (VVA). This is a condition that makes having sex painful and difficult for many women after menopause due to alkalinity, dryness, irritation and thinning of the female lower reproductive tract. Also widely known as DHEA (dehydroepiandrosterone), prasterone is a natural steroid hormone produced mainly by the adrenal glands and then converted into estrogens and androgens. Biological prasterone production gradually decreases, beginning at about 30 years of age, resulting in declining levels of the sex hormones. At menopause, estrogen levels drop further. Usually marketed as DHEA, oral forms of prasterone are sold over the counter as nutritional supplements, but no evidence supports their effectiveness for any medical condition. Intrarose is the first prescription prasterone to be FDA approved. It will be available as 6.5mg vaginal inserts that are used once a day. Price, launch details and prescribing information are currently not available.

 
23Nov

Happy Thanksgiving!

In observance of the Thanksgiving holiday, AFSPA will close at 12 noon ET on Wednesday, November 23. We will remain closed on Thursday and Friday, November 24 and 25, and we will resume normal business hours at 8:30 am ET on Monday, November 28.

Throughout the year, the Board of Directors and Staff of AFSPA are grateful for the loyalty and membership of all our members around the world. Thank you for trusting us to serve you and your family. We wish each of you a very Happy Thanksgiving!

 
11Nov

The governor of North Carolina has declared a State of Emergency

The governor of North Carolina has declared a State of Emergency in the following counties due to wildfires: Alexander, Avery, Buncombe, Burke, Caldwell, Catawba, Cherokee, Clay, Cleveland, Gaston, Graham, Haywood, Henderson, Jackson, Lincoln, Macon, Madison, McDowell, Mitchell, Polk, Rutherford, Swain, Transylvania, Watauga and Yancey.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an emergency benefit override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide temporary alternate addresses (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed.

 
9Nov

Deadline for Taking Your HRA and Biometric Screening

Deadline for Taking Your Health Risk Assessment and Biometric Screening

We want you to be healthy.  We also want you to be able to earn our Wellness Incentives as part of our Simple Steps to Living Well Together Program. 

You still can sign into My Online Services and take your Health Risk Assessment (HRA). An HRA is like an interview you take online. You share information about your health habits and history.  Then, you get a personalized health summary that can help you understand your health needs.  Taking an HRA will earn you a $100 incentive reward.  Do it today, if you haven’t already done so.  You have until 12/31/16 to take this year’s HRA.

If you haven’t already obtained your Biometric Screening, you should do so now.  The deadline for the screening is 12/9/16 (Note:  You must take the HRA before the biometric screening to qualify for the separate $100 biometric screening incentive reward, so time is running very short for the screening.).  Your screening serves as a benchmark and can help evaluate changes in health status over time. 

And, don’t forget the Healthy Actions we offer.  There’s still time to complete some of them before the end of the year.  Doing so will earn you yet another separate $50 incentive reward.

See your 2016 FSBP Brochure for complete details

 
7Nov
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Generics to Azor Launched

On November 2, 2016, Ajanta Pharma announced the launch of its AB-rated generic to Daiichi Sankyo's Azor® (amlodipine / olmesartan medoxomil) tablets. Azor contains amlodipine, a dihydropyridine calcium channel blocker, and olmesartan medoxomil, an angiotension II receptor blocker. Azor is approved for the treatment of hypertension (high blood pressure). Additional generic manufacturers have received approval from the U.S. Food and Drug Administration (FDA) for their AB-rated generics to Azor; however, they have not announced the launch of these products. Sun Pharma has also launched an authorized generic to Azor. According to IMS Health, 2015 annual sales for Azor were $340 million.

 
2Nov
Express Scripts News Flash

Express Scripts News Flash

Generics to Seroquel XR Launched

Par Pharmaceutical, an operating company of Endo Pharmaceuticals, began shipping four strengths of quetiapine extended-release tablets to U.S. wholesalers on November 1, 2016. Par’s generics are AB-rated to AstraZeneca’s Seroquel XR®, a once-daily atypical antipsychotic. It is indicated for bipolar disorders, depression, mania and schizophrenia. As the result of a settlement agreement, Par is launching one year before the Seroquel XR patent expires. It has 180-days of exclusivity for the 50mg, 150mg, 200mg and 300mg tablet strengths. A separate agreement allows Accord Healthcare, Inc. to launch the 400mg strength, effective November 1, as well.

  • Brand Drug: Seroquel XR® (quetiapine extended release - AstraZeneca)
  • Indications: add-on treatment for patients with major depressive disorder that does not respond to antidepressants, alone; acute depressive, manic or mixed episodes in bipolar disorder; maintenance of bipolar disorder and schizophrenia
  • Generic Manufacturer: Par Pharmaceutical; Accord Healthcare, Inc.
  • Launch Date: November 1, 2016
  • Dosage Forms Available: 50mg, 150mg, 200mg and 300mg extended-release tablets from Par: 400mg extended-release tablets from Accord
  • Annual U.S. Sales: For the four strengths that Par has launched, IMS Health estimates U.S. sales at $911 million for the 12-month period that ended on September 30, 2016. For calendar year 2015, U.S. sales of Seroquel XR 400mg amounted to approximately $470,000.
  • Seroquel XR is the first extended-release atypical antipsychotic to face generic competition in the U.S.
  • Other extended-release atypical antipsychotics are all brand-name and all injectable: Abilify Maintena® (aripiprazole extended-release powder for suspension for injection - Otsuka), Invega Sustenna® and Invega Trinza® (paliperidone extended-release suspension for injection - Janssen), Risperdal® Consta® (risperidone powder for solution for injection – Janssen) and Zyprexa® Relprevv™ (olanzapine powder for suspension for injection – Lilly).
  • The market for immediate release atypical antipsychotic medications includes Abilify (aripiprazole - Bristol-Myers Squibb/Otsuka, generics) Clozaril® (clozapine - Novartis, generics), Fanapt™ (iloperidone – Vanda), Geodon® (ziprasidone – Pfizer, generics), Invega™ (paliperidone – Janssen), Latuda® (lurasidone– Sunovion), Rexulti® (brexpiprazole – Otsuka/Lundbeck), Risperdal® (risperidone - Janssen, generics), Saphris® (asenapine – Merck / Actavis), Seroquel® (quetiapine – AstraZeneca, generics) Vraylar® (cariprazine - Allergan) and Zyprexa® (olanzapine – Lilly, generics).
 
1Nov
From the CEO

From the CEO

Welcome to November 2016!

As the year comes to an end, this season calls for planning and preparation for the upcoming year. Open Season starts this month, which is a great time to take a look at all your benefits. Consider adding dental coverage, life insurance, or a disability plan from AFSPA. Many of you trust us with your medical health, why not trust with your other needs too?   

To start, the Self Plus One rate for the Foreign Service Benefit Plan (FSBP) actually is lower than the Self and Family rate this year. For two person families, this Open Season may be the time to switch to Self Plus One. The Self Plus One enrollment type covers the enrollee and one other eligible family member you designate to be covered. In 2017, those on a Self and Family plan may want to explore Self Plus One to see if it works for you.

Many of our members have chosen to join us on Facebook. With nearly 300 fans, AFSPA is able to hear from you in a whole new way. We share healthy living ideas, fitness tips, and member benefits. This Open Season, AFSPA will use social media to connect with you even more. We will post useful information every day during Open Season. Please check our Facebook page every day between mid-November and mid-December. You will learn something new to use all year long.

Open Season officially begins Monday, November14, 2016. As you know, AFSPA staff travel to various regions of the globe in preparation for Open Season. Any direct hire Federal employee who is enrolled or is eligible to enroll in any plan under the FEHB Program may want to  attend these briefings. This year’s topics include OPM Initiatives, Prescription Drugs, Access to Care, Wellness Programs, FSAFEDS, and FEDVIP. Please plan to attend and bring your questions. See the November schedule below (subject to change – check with local HR offices):

November 1- Wiesbaden, Open Season Briefing (Teachers), Wiesbaden Middle School, Media Center, 3:30pm

November 2- Stuttgart, Open Season Briefing (Teachers), Patch Elementary School, Library, 3:15pm

November 3 – Yokosuka, Open Season Briefing (Civilians), Building A-20, Classroom, 10:30am

November 3 – Yokosuka, Open Season Briefing (Teachers), Sullivan School Complex, Multi-Purpose room, 3:00pm

November 3- Kaiserslautern, Open Season Briefing (Civilians & Teachers), Kaiserslautern Middle/High School, Pulaski Barracks Info Center, 3:30pm

November 4 – Embassy Tokyo, Open Season Briefing, Foley Room (2nd Floor), 9:00am

November 7- Kadena, Medicare & FEHB, Building 721, 2nd Floor, 9:30amNovember 7-Kadena, Open Season Briefing (Teachers), Kadena High School, Library, 4:00pm

November 7 – Yokota Air Force Base, Open Season Briefing (Teachers), Mendel Elementary School, Training Room, 3:00 pm

November 8- Kadena, Open Season Briefing (Civilians), Building 721, 2nd Floor, 11:00am

November 8- Kadena, Open Season Briefing (Teachers), Lester Middle School, Library, 4:00pm

November 8- Atsugi, Open Season Briefing (Teachers), Shirley Lanham Elementary School, Library, 3:00pm

November 8- Frankfurt, Combined Open Season and Medicare & FEHB Briefing U.S. Consulate Auditorium, 10:00am

November 8- Frankfurt, Combined Open Season and Medicare & FEHB Briefing, U.S. Consulate Auditorium, 2:00pm

November 10 – Embassy Seoul, Open Season Briefing, 1st Floor Conference Room, 11:30 am

November 14 – Yongsan, Medicare & FEHB, South Post Chapel, Room 208 and 209, 9:30am

November 14 – Yongsan, Open Season Briefing, South Post Chapel, Room 208 and 209, 1:00pm

We hope to see you at one of our Open Season Briefings.

In addition, we will be attending several domestic Agency / Department Open Season Health Fairs.

By the way, Happy Thanksgiving! This year, thank your body by maintaining a healthy diet during the traditional gatherings. Reduce your salt intake, control your portions, and load your plate with vegetables. This might be a good time to take advantage of the Live “Not One Ounce” Program offered by the Mediterranean Wellness Program.  See page 83 of the 2016 FSBP Brochure for details.

As always, thank you for your trust and for giving us the opportunity to serve you.

To Your Health,

Paula S. Jakub, RHU
CEO, AFSPA
Executive Director, Senior Living Foundation

 
31Oct
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Zinplava Approved

A monoclonal antibody, Zinplava™ (bezlotoxumab – Merck), was approved on October 21, 2016, as ancillary treatment to decrease the likelihood of a relapse with a specific bacterial infection. It is approved by the U.S. Food and Drug Administration (FDA) for use in combination with an antibacterial drug, for preventing recurrence of Clostridium difficile (C. diff) infection for patients who are at least 18 years old, who are undergoing antibacterial treatment for C. diff and who are at high risk of acquiring the infection again. The chance of an initial C. diff infection is greater for patients who recently have taken antibiotics, especially individuals with immunocompromising conditions, those who are hospitalized and those living in a nursing facility. About 25% of patients once infected with C. diff will become reinfected, and around 10% will have more than one additional C. diff infection. Toxic substances produced by C. diff attack the linings of the stomach and intestines to cause abdominal pain, diarrhea and fever. Although it is not an antibacterial drug, Zinplava sticks to toxin B, reducing its ability to damage gastrointestinal (GI) cells. Recommended dosing is 10mg/Kg given as a single intravenous (IV) infusion over a one-hour period. It must be used in conjunction with an antibacterial agent. Zinplava, which will be packaged in single-use, 40mL vials containing 25mg/mL (1,000mg total), will be launched early in 2017. Click here for Prescribing information.

New Indication for Keytruda

On October 24, 2016, Merck’s Keytruda® (pembrolizumab) received FDA approval as initial therapy for metastatic non-small cell lung cancer (NSCLC) without epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations, but expressing 50% or more of programmed death ligand 1 (PD-L1). The presence of PD-L1 must be verified by an FDA-approved diagnostic test. In a labeling change announced at the same time, additional information was added from studies of patients who have metastatic NSCLC that produces at least 1% of PD-L1 and that advances despite treatment with chemotherapy regimens containing platinum. For NSCLC, 200mg of Keytruda is given once every three weeks as a 30-minute IV infusion. Previous approvals for Keytruda include melanoma and head and neck cancers. Click here for Keytruda’s full prescribing information.

New Generic for Concerta

Last week, FDA announced that it was initiating actions to revoke approval for two extended-release methylphenidate products that are rated BX (presumed therapeutically inequivalent) to Concerta® (methylphenidate – Janssen). Only a few days later, on October 21, 2016, an AB-rated (therapeutically equivalent) generic for Concerta gained FDA approval. Its AB rating means that the new generic is interchangeable with Concerta. Its manufacturer, Mylan, has not yet released any launch or pricing details. Actavis distributes an authorized generic, which will remain on the market.

MedWatch Update

Testosterone

FDA is requiring new warnings for prescription products that contain testosterone as well as other anabolic androgenic steroids. In the U.S., all anabolic androgenic steroids are Schedule 3 (C-III) controlled substances. In a safety alert dated Oct. 25, 2016, FDA now requires that labeling for testosterone and other anabolic steroids include more information about their side effects as well as about the risks of abuse and dependence that may be associated with using them. The additions highlight that anabolic androgenic steroids can cause severe side effects that include heart attacks, liver damage and strokes. Among other serious adverse effects that may be associated with using drugs in the class are depression, hostility, infertility and insomnia. Even though it is approved for treating low testosterone levels caused by certain disorders, testosterone is not indicated to counteract the normal effects of aging. It also is misused in other unapproved ways, such as by bodybuilders attempting to increase their muscle mass. Additionally, individuals who use anabolic androgenic steroids may become dependent. For more information, the FDA advisory is available here.

 
27Oct
Express Scripts News Flash

Express Scripts News Flash

Generic Benicar Launched

Mylan announced the launch of its AB-rated generic to Daiichi Sankyo's Benicar® (olmesartan) and Benicar HCT® (olmesartan/ hydrochlorothiazide). Benicar and Benicar HCT are indicated for the treatment of hypertension (high blood pressure). Mylan currently is the only manufacturer that has final FDA approval for these generics. However, the company’s eligibility for 180 days of generic exclusivity is not known. As a result, additional manufacturers may be able to introduce generics earlier than April 2017, depending on court orders and final FDA approvals. Mylan has already begun shipping its generics.

  • Brand (Generic) Name: Benicar® (olmesartan - Daiichi Sankyo) and Benicar HCT® (olmesartan/ hydrochlorothiazide – Daiichi Sankyo)
  • Manufacturer: Mylan
  • Indication: Treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure.
  • Dosage Forms Available: Generics to Benicar are available as 5mg, 10mg and 20mg tablets. Generics to Benicar HCT, expressed as olmesartan/hydrochlorothiazide, are available as 20mg/12.5mg, 40mg/12.5mg and 40mg/25mg tablets.
  • Launch Date: October 26, 2016
  • Annual U.S. Sales: According to IMS, U.S. annual sales for Benicar and Benicar HCT are approximately $1 billion and $805 million, respectively.
  • Benicar belongs to a class of drug for treating high blood pressure known as angiotensin II receptor blockers, or ARBs.
  • Other competing ARBs include: Atacand® (candesartan -- AstraZeneca, generics), Avapro® (irbesartan -- Sanofi, generics), Cozaar® (losartan -- Merck, generics), Diovan (valsartan -- Novartis, generics), Edarbi® (azilsartan -- Arbor/Takeda), Micardis® (telmisartan -- Boehringer Ingelheim, generics) and Teveten® (eprosartan -- AbbVie, generics).
  • Sun Pharma launched authorized generics (AGs) to Benicar and Benicar HCT. The company also launched AGs to Daiichi Sankyo’s Azor® (amlodipine/olmesartan) and Tribenzor® (amlodipine/olmesartan/hydrochlorothiazide), two additional combination products for treating high blood pressure.
  • True AB-rated generics to Azor and Tribenzor have also been approved. However, we have yet to see a press release announcing a product launch. These products had U.S. annual sales of $340 million and $208 million, respectively.
 
25Oct
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Tecentriq Approved for Lung Cancer

On October 18, 2016, Genentech’s Tecentriq™ (atezolizumab) was approved by the U.S. Food and Drug Administration (FDA) to treat patients with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK gene abnormalities. Tecentriq is a programmed death receptor-ligand 1 (PD-L1)-blocking antibody. It is an immunotherapy that helps the body’s immune system attack cancer cells. Tecentriq was originally approved on May 18, 2016, for the second-line treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC). The recommended dose of Tecentriq for NSCLC and mUC is 1200mg as an intravenous infusion over 60 minutes once every three weeks. Click here for full prescribing information.

First Vagifem Generic Launched

Yuvafem® (estradiol vaginal inserts), the first generic for Novo Nordisk’s Vagifem® was released in the U.S. by Amneal Pharmaceuticals on October 17, 2016. Each intravaginal insert contains a low dose of estradiol intended to treat atrophic vaginitis (dryness, irritation, itching and pain) after menopause. Dosing is one insert per day for the first two weeks, then two inserts per week spaced about three days apart. Yuvafem will be dispensed in packages of eight and 18 inserts -- each in a disposable applicator. Its labeling carries boxed warnings common to all estrogens. Used alone, it may raise the risk of breast or endometrial cancers, blood clots or strokes. When used along with a progestin, estrogens may contribute to cardiovascular conditions and possibly to dementia. No cost information is available for Yuvafem. IMS Health estimates that sales of Vagifem totaled $423 million for the 12-month period ending July 31, 2016.

Inflectra to Launch in Late November

On October 17, 2016, Pfizer announced that it will launch Inflectra™ (infliximab-dyyb), a biosimilar to Janssen’s Remicade®, in late November. Inflectra was approved on April 5, 2016, for all Remicade-approved indications, except pediatric ulcerative colitis. It will be used for treating patients with rheumatoid arthritis, adult ulcerative colitis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and adult and pediatric Crohn’s disease. Inflectra, a tumor-necrosis factor (TNF) blocker, was the first biosimilar monoclonal antibody to gain FDA approval. Based on the wholesale acquisition cost (WAC), Inflectra will be priced at a 15% discount to Remicade. Sandoz’s Erelzi™ (etanercept – szzs), a biosimilar to Amgen’s Enbrel®, and Amgen’s Amjevita™ (adalimumab – atto), a biosimilar to AbbVie’s Humira® are additional TNF blocker biosimilars that have been FDA approved. The launch of Erelzi and Humira could be delayed for two or more years due to patent litigation.

New Dose Form for Lucentis

Genentech announced on October 14, 2016, that it has received FDA approval for pre-filled syringes each containing 0.5mg of Lucentis® (ranibizumab injection). Lucentis is a monoclonal antibody that is injected into the vitreous humor (jellylike filling of the eyeballs) once a month by ophthalmologists who are specifically trained in its use. It is indicated to treat wet age-related macular degeneration (AMD), diabetic macular edema (DME) and macular edema caused by retinal vein occlusion (RVO). By blocking receptors for vascular endothelial growth factor (VEGF), it lessens new blood vessel formation and helps to keep blood from seeping out of leaky vessels. Pre-filled syringes simplify the injection procedure by eliminating the need to draw the medication from a vial. They are expected to be marketed early in 2017. Click here for prescribing information.

MedWatch Update

Generics for Concerta

Following up on previous actions, FDA has begun proceedings to rescind its approvals for two generics of Janssen’s Concerta® (methylphenidate) extended-release tablets. In November 2014, FDA amended its Draft Guidance on Methylphenidate Hydrochloride to revise the methods for determining bioequivalence (interchangeability) of methylphenidate products. At that time, FDA notified the manufacturers of the two generics available in the U.S. that the bioequivalence ratings of their products changed from AB-rated (therapeutically equivalent) to BX (presumed therapeutically inequivalent) under the new guidance. No safety issues were found with either generic, so they still can be prescribed and dispensed. However, they cannot be interchanged automatically with Concerta. Both companies, Mallinckrodt and Kudco, had the options of removing their generic product from the U.S. market or carrying out biequivalency studies to show therapeutic effects comparable to Concerta’s. Kudco subsequently was sold to UCB/Kremers Urban, which then was bought by Lannett in 2015. Neither Lannett nor Mallinckrodt has complied with the FDA directive, so both have been given 30 days to request a hearing. If a hearing is granted, an additional 30 days is allowed for all information needed to prove the generic is bioequivalent. If they do not respond or fail to support bioequivalence, FDA will withdraw approval and the products will no longer be available in the U.S. An authorized generic made by Janssen will continue to be distributed under the Actavis label. For more information, please see the FDA Drug Safety Communication by clicking here

Updated Hepatitis C Issues Document Available

The standard of care for treating chronic hepatitis C (CHC) has been evolving. This Issues Document is intended to describe current and pipeline medications for treating hepatitis C and how Express Scripts and Accredo can effectively manage the evolving market. This latest update includes the recent approval of Viekira XR. The pipeline table has also been updated. Click here for the Hepatitis C Issues Document.

 
21Oct
Clinical Matters News Flash

Clinical Matters News Flash

Lilly Receives Approval for Lartruvo

Lartruvo™ (olaratumab injection, 10mg/mL – Eli Lilly and Company) received U.S. Food and Drug Administration (FDA) approval on October 19, 2016. It is the first monoclonal antibody to be indicated for treating adults with soft tissue sarcomas (STS) that have histologic subtypes appropriate for an anthracycline-containing regimen, but that are not amenable to curative treatment with radiation or surgery. Recommended dosing for Lartruvo is on 21-day cycles with 15mg/Kg given as a 60-minute intravenous (IV) infusion on the first and eighth days. Doxorubicin is given along with Lartruvo for the first eight cycles. Treatment continues until the patient can no longer tolerate side effects or until the cancer ceases to respond. In the open-label, phase II JGDG clinical trial, median overall survival was nearly one year longer among patients using Lartruvo and doxorubicin than among patients on doxorubicin alone. Accredo will be the exclusive provider for Lartruvo. Click here for full prescribing information.

  • Brand (Generic) Name: Lartruvo™ (olaratumab injection, 10mg/mL)
  • Manufacturer: Eli Lilly and Company
  • Date Approved: October 19, 2016
  • Indication: Along with doxorubicin for initial treatment of adults with soft tissue sarcoma (STS) with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery
  • Dosage Forms Available: single-use, 50mL vials each containing 500mg of Lartruvo
  • Launch Date: Lilly expects Lartruvo to be available within the next few weeks.
  • Estimated Annual Cost: Not yet available
  • Specialty Status: Lartruvo will be added to Express Scripts’ specialty drug list.
  • Sarcomas (cancers in connective tissues) can occur in various types of soft tissues, such as cartilage, fat, muscles and nerves.
  • According to the National Cancer Institute (NCI), approximately 12,000 Americans per year are diagnosed with an STS.
  • Lartruvo is the first monoclonal antibody to be FDA approved for treating STS.
  • It will be infused along with doxorubicin on days one and eight for eight 21-day cycles. If further treatment is needed, Lartruvo is used alone.
  • Under FDA’s Accelerated Approval, Breakthrough and Fast-Track procedures, approval for Lartruvo was granted from phase II clinical data. It also has been designated as an orphan drug. Positive results from the ongoing phase III ANNOUNCE trial will be needed for full approval.
 
18Oct
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Intravenous Carbamazepine Approved

On October 7, 2016, the U.S. Food and Drug Administration (FDA) approved the first intravenous (IV) form of carbamazepine, a medication that treats epilepsy. Lundbeck’s Carnexiv™ (carbamazepine) is indicated for adults who need temporary (seven days or less) replacement for oral epilepsy therapy. It is approved for patients who have generalized tonic-clonic seizures, partial seizures with complex symptomology, certain kinds of mixed seizure patterns and other generalized or partial seizures. All carbamazepine products, including Carnexiv, have a boxed warning about potentially life-threatening skin reactions, such as Stevens-Johnson syndrome, that they may cause, especially for patients of Asian backgrounds. With launch expected early in 2017, Carnexiv will be dispensed as 200mg/20mL single-use vials. Recommended dosing is 70% of the daily oral dose that the patient had been taking divided into four infusions each given over 30-minutes at six-hour intervals. Click here for prescribing information.

FDA Approves Flublok Quadrivalent

Protein Sciences Corporation announced on October 11, 2016, that FDA has approved a quadrivalent (effective against four different influenza strains) formulation of its Flublok® (influenza vaccine). It is indicated for adults 18 and older. Because it contains more active antigens than other flu vaccines available in the U.S., Flublok Quadrivalent may provide better protection than vaccines with fewer antigens, particularly for individuals who are 50 and older and patients with immunocompromising conditions. Additionally, all Flublok vaccines are recombinant -- they are made in cultured cells without antibiotics, animal cells, eggs, live influenza virus or preservatives. Flublok Quadrivalent will be launched next year in pre-filled, single-dose syringes for intramuscular (IM) injection.

Generic to Beyaz Available

Teva Pharmaceuticals announced the launch of its A-rated generic to Bayer’s Beyaz® (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.02 mg/0.451 mg and levomefolate calcium tablets, 0.451 mg), an oral contraceptive primarily used by women to prevent pregnancy. It can also be used to treat premenstrual dysphoric disorder (PMDD) and moderate acne for women at least 14 years of age. Teva’s generic, made available under the trade name of Rajani™, is available in 28-day blister packs.  According to IMS Health data, Beyaz had annual sales of approximately $133 million in the U.S. for the 12 months ending July 2016.

Infant-Specific Dose of Pertzye Approved

On October 11, 2016, Digestive Care, Inc. and Chiesi USA announced that FDA approved Pertzye® (pancrelipase) in a 4,000 USP lipase units delayed-release capsule strength. Pertzye is a combination of porcine-derived lipases, proteases, and amylases indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions. The recommended dose for infants up to 12 months of age is 4,000 lipase units (one capsule) per 120mL of formula or per breast-feeding. Pertzye has been on the market since 2012 and is currently supplied as delayed-release capsules containing 8,000 USP lipase units and 16,000 USP lipase units. It is approved for use in patients of all ages; dosing varies depending on a patient’s weight and age. Click here for updated prescribing information.

2016-2017 Influenza Season Issues Document Available

The best way to keep from getting influenza (flu) is to get an influenza vaccination before the start of the flu season each year. This document provides a general update for the 2016?2017 flu season and highlights Express Scripts program offerings. Click here for the Issues Document.

Generics to Benicar Issues Document Available

U.S. Patents on Daiichi-Sankyo’s Benicar® (olmesartan) expire on October 25, 2016. The first generics for it and for its combination product – Benicar HCT® (olmesartan/hydrochlorothiazide) are expected to be launched soon thereafter. Generics for other olmesartan combinations, Azor® (olmesartan/amlodipine) and Tribenzor® (olmesartan/amlodipine /hydrochlorothiazide), also could reach the U.S. market. This document provides information regarding the high blood pressure market, focuses on the impact of olmesartan generics, and highlights how Express Scripts’ utilization management programs help to assure affordable, clinically appropriate care. Click here for the Generics to Benicar Line Issues Document.

Updated Biosimilars Issues Document Available

The Emerging Therapeutics department has updated the Biosimilars Issues Document to note the approvals of Sandoz’s Erelzi™ (etanercept–szzs) and Amgen’s Amjevita™  (adalimumab–atto). Click here for the Biosimilars Issues Document.

 
12Oct
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

New Strength for Zubsolv

A new, low strength of Zubsolv® (buprenorphine 0.7mg/naloxone 0.18mg) sublingual tablets was approved by the U.S. Food and Drug Administration (FDA) on October 4, 2016. Zubsolv is a CIII controlled substance that -- along with counseling and psychosocial support -- treats adults with opioid dependence disorder. It already had been FDA approved in five higher strengths for both of its components. Its manufacturer, Orexo US, believes that the range of available strengths will better allow prescribers to tailor each patient’s therapy to individual needs. After patients show signs of opioid withdrawal, Zubsolv is given as several doses on the first day, and then decreased to once a day. A Medication Guide and product labeling warn that it contains buprenorphine, an opioid that can be abused. As with all opioids, it also can cause potentially severe breathing problems and it can be life-threatening if swallowed by children. The naloxone component has very little activity when taken sublingually, but it blocks the euphoric effects of buprenorphine if the tablets are crushed, dissolved and injected. Zubsolv patients should be supervised by a healthcare professional and refills for prescriptions should be limited to a few days at a time, at least until an effective dose is determined. Orexo plans on launching the new strength early next year. Click here for complete prescribing information for current strengths of Zubsolv. 

MedWatch Update

Direct-Acting Antivirals

FDA is requiring a boxed warning to be added to the labeling and Medication Guides of direct-acting antiviral (DAA) drugs, which are used to treat chronic hepatitis C. On October 4, 2016, FDA released a Safety Communication warning that hepatitis B may return or be worsened for patients who take a DAA and who have or who have had hepatitis B. Between late November 2013 and mid-July 2016, FDA documented over 20 cases of hepatitis B that was reactivated by a DAA. Three of the cases were severe – resulting in a liver transplant or death. Before starting treatment for hepatitis C, patients should let their doctors know if they also have or had hepatitis B. Additionally, patients taking a DAA should immediately report symptoms, such as extreme fatigue, light-colored stools, loss of appetite, nausea, vomiting and yellowed eyes or skin, that could indicate liver damage from reactivated hepatitis B. Healthcare providers are advised to test hepatitis C patients for hepatitis B, as well. All DAAs will carry the new warning. Those currently approved in the United States, are Daklinza™ (daclatasvir), Epclusa® (sofosbuvir/velpatasvir), Harvoni® (sofosbuvir/ledipasvir), Olysio® (simeprevir), Technivie® (ombitasvir/paritaprevir/ritonavir), Viekira® Pak and Viekira XR™ (dasabuvir/ombitasvir/paritaprevir/ ritonavir) and Zepatier™ (elbasvir/grazoprevir). Click here for more information about the new warning.

Updated DrugWatch Document Available

The Emerging Therapeutics department has updated DrugWatch, a document that highlights near-term pipeline drugs as well as potential new generic opportunities. Click here for the updated DrugWatch document.

 
5Oct

The governors of Florida, Georgia, North Carolina and South Carolina have declared a state of emergency

The governors of Florida, Georgia, North Carolina and South Carolina have declared a state of emergency as a result of Hurricane Matthew for the following counties:

Florida:  All counties are affected

Georgia: Brantley, Bryan, Bulloch, Camden, Charlton, Chatham, Effingham, Evans, Glynn, Liberty, Long, McIntosh and Wayne

North Carolina: Alamance, Anson, Beaufort, Bertie, Bladen, Brunswick, Camden, Carteret, Caswell, Chatham, Chowan, Columbus, Craven, Cumberland, Currituck, Dare, Davidson, Davie, Duplin, Durham, Edgecombe, Forsyth, Franklin, Gates, Granville, Greene, Guilford, Halifax, Harnett, Hertford, Hoke, Hyde, Johnston, Jones, Lee, Lenoir, Martin, Montgomery, Moore, Nash, New Hanover, Northampton, Onslow, Orange, Pamlico, Pasquotank, Pender, Perquimans, Person, Pitt, Randolph, Richmond, Robeson, Rockingham, Sampson, Scotland, Stokes, Surry, Tyrrell, Vance, Wake, Warren, Washington, Wayne, Wilson, and Yadkin.

South Carolina: All counties are affected.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an emergency benefit override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide temporary alternate addresses (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed.

 
3Oct
Express Scripts News Flash

Express Scripts News Flash

Generic Launched for Epzicom

On September 28, 2016, Teva Pharmaceutical Industries introduced to the U.S. market a generic for the combination drug, Epzicom® (abacavir/lamivudine). Taken once daily, it is indicated for use along with other antiretroviral drugs for treating HIV-1 infection in adults and children who weigh at least 25Kg (55 pounds). Each tablet contains 600mg of abacavir and 300mg of lamivudine. Both are nucleoside reverse transcriptase inhibitors (NRTIs). Labeling carries a boxed warning about the drug’s potential to cause hypersensitivity reactions, lactic acidosis and hepatomegaly. It also may worsen hepatitis B for co-infected patients who take it. The status of additional generics is not yet known.

  • Brand (Generic) Name: Epzicom® (abacavir/lamivudine)
  • Brand Manufacturer: ViiV Healthcare
  • Generic Manufacturer: Teva Pharmaceutical Industries
  • Indication: In combination with other antiretroviral agents for treating HIV-1 infection
  • Dosage Forms Available: tablets containing 600mg of abacavir and 300mg of lamivudine
 
3Oct
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Stelara Approved for Crohn’s Disease

The U.S. Food and Drug Administration (FDA) authorized an additional indication for Janssen Biotech’s Stelara® (ustekinumab) on September 23, 2016. Stelara, a monoclonal antibody that targets interleukins 12 and 23 (IL-12 and IL-23), is already FDA approved for treating psoriasis and psoriatic arthritis. Its new indication is to treat adults who have moderate to severe active Crohn’s disease that has not responded to corticosteroids, immunomodulators or tumor necrosis factor (TNFα) inhibitors. A first dose of up to 520mg is determined by the weight of the patient and infused intravenously (IV) by a healthcare provider. Then, beginning eight weeks after the initial dose, recommended dosing is 90mg of Stelara subcutaneously once every eight weeks. A Medication Guide dispensed with each prescription informs patients and caregivers how to use pre-filled syringes for giving the injections. Click here for updated prescribing information.
Orkambi Receives New Indication

A combination cystic fibrosis drug made by Vertex pharmaceuticals received an additional FDA indication on September 28, 2016. Orkambi® (lumacaftor/ivacaftor) now is approved to treat cystic fibrosis patients who have two mutated copies of F508del on the cystic fibrosis transmembrane conductance regulator (CFTR) gene and who are between six and 12 years of age (approximately 2,400 American patients). Orkambi initially was approved by FDA in July 2015 for treating patients age 12 years and older who have the same genetic mutation (about 8,500 U.S. patients). It is the only drug that specifically affects F508del mutations, which are the most common ones in cystic fibrosis. Lumacaftor corrects CFTR and ivacaftor enhances it. For children between six and 12 years of age, the recommended dose is two tablets containing 100mg of lumacaftor and 125mg of ivacaftor once every 12 hours. To maximize its absorption, Orkambi should be taken along with foods, such as cheese, eggs and peanut butter, which contain fat. Vertex is conducting further clinical studies on Orkambi’s use for children as young as two years of age. Click here for prescribing information.

Labeling Update for Rexulti 

Rexulti® (brexpiprazole) was granted FDA approval on September 23, 2016, to include the results from a clinical trial in its prescribing information. In July 2015, it was FDA approved as a single therapy to treat schizophrenia and as add-on treatment for major depression. The continuation of a previous trial found that patients with schizophrenia who were stabilized on Rexulti and kept taking it had longer times to relapse than study patients who were switched to an inactive placebo. Labeling now can include information about its use as schizophrenia maintenance therapy. Rexulti is an atypical antipsychotic that is believed to work by partially activating both dopamine and serotonin receptors to help regulate neurotransmitter levels. A boxed warning cautions that Rexulti should not be used by elderly patients with psychoses due to dementia and that patients younger than 24 years of age should be watched for behavioral changes while they take it. Rexulti was developed jointly by H. Lundbeck A/S and Otsuka Pharmaceutical Company. Click here for complete prescribing information.

 
1Oct
From the CEO

From the CEO

Welcome to Fall 2016!

I am so pleased to announce the Foreign Service Benefit Plan’s 2017 Premiums:

Foreign Service Benefit Plan 2017 Premiums

Bi-Weekly Premium

 

Monthly Premium

Self Only            Code 401

Self Plus One Code 403

Self & Family Code 402

 

Self Only Code 401

Self Plus One Code 403

Self & Family     Code 402

$  64.44

$157.84

$159.41

 

 $139.62

  $341.99

   $345.40

 

 

 

 

 

 

 

At a time when the average increase in premiums for the Federal Employees Health Benefits Program is 6.2%, we are most gratified to have kept our premiums stable.  Our Self Only and Self and Family premiums are increasing only 2%, while our Self Plus One premium has gone down 12¢.

See our Open Season announcement on our home page for complete information about benefit enhancements.

In many parts of the world, Fall means transitioning from warm weather to cold weather. You may want to consider getting a flu shot. For the best protection, every family member over the age of six months should get vaccinated annually. The Foreign Service Benefit Plan (FSBP) covers flu vaccinations at 100% when obtained at an in-network provider or provider outside the U.S.

So, have you moved? If so, please let us know. As you leave one post for another, please send us your updated mailing address, telephone number(s), and e-mail address. You can update your contact information via the Member Portal. We want you to receive your reimbursement checks and member communications in a timely manner. Please tell us if you change locations so we can stay in touch.

Open Season is fast approaching. This year, the enrollment period is from November 14 to December 12, 2016. AFSPA staff always travel to various regions of the globe in preparation for Open Season. Any Direct Hire Federal employee who is enrolled or is eligible to enroll in any plan under the Federal Employees Health Benefits (FEHB) Program is invited to attend.  This year’s topics include:

  • Benefits and OPM Initiatives
  • Prescription Drugs
  • Access to Care
  • Wellness Programs
  • Overseas Considerations
  • FSAFEDS
  • FEDVIP

See a few October dates below:

October 24 – Alconbury Middle School, Library – 3:15pm

October 25 – Lakenheath High School, Library – 4pm

October 26 – US Embassy, London, Cafeteria Lobby – 9:00am

For a complete list of our Open Season visits this year, please email [email protected].

If you are in the area, please plan to attend one of our Open Season briefings. And look out for our new Fall Newsletter in your mailbox. It is full of new information about our new 2017 benefits.

As always, thank you for your trust and for giving us the opportunity to serve you.

To Your Health,

Paula S. Jakub, RHU
CEO, AFSPA
Executive Director, Senior Living Foundation

 
26Sep
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Amjevita, a Biosimilar to Humira, Approved

On September 23, 2016, the U.S. Food and Drug Administration (FDA) approved Amgen’s Amjevita™ (adalimumab – atto), a biosimilar to AbbVie’s Humira®. Amjevita is approved for treating adults with rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease and ulcerative colitis. It is also approved for treating children four years of age and older with polyarticular juvenile idiopathic arthritis. The dose of Amjevita varies depending on the indication. While Amgen’s launch plans for Amjevita are unknown, it is possible that launch could be delayed for several years due to patent litigation. Amjevita will be added to Express Scripts’ specialty drug list. Express Scripts is reviewing the data around Amjevita for a possible utilization management strategy. Click here for full prescribing information.

Kyleena Long-Acting Contraceptive Approved

On September 16, 2016, the U.S. Food and Drug Administration (FDA) approved Bayer Pharmaceuticals’ Kyleena™ (levonorgestrel-releasing intrauterine system). It is a long-acting reversible contraceptive (LARC). As an intrauterine device, (IUD), Kyleena must be inserted and removed by a healthcare provider. It prevents pregnancy for up to five years by slowly releasing a low dose of progestin. It may be removed earlier, if needed; and it does not affect fertility after removal. Hormonal IUDs, such as Kyleena, are more effective at preventing pregnancy than other reversible forms of contraception. Bayer plans to launch it in October 2016. It will be available through a limited network of specialty pharmacies that does not include Accredo. Kyleena will be added to Express Scripts’ specialty drug list. Click here for complete prescribing information.

Lomaira Approved for Weight Loss

KVK-Tech, Inc. received FDA approval on September 12, 2016, for Lomaira™ (phentermine) tablets, 8mg. Lomaira is indicated to be used no longer than a few weeks for patients 18 years of age and older who need to lose weight. Behavior modification, calorie restriction and exercise are recommended along with its use. It is intended for patients who have a body mass index (BMI) in the obese range (30kg/m2 or above) and for overweight patients (BMI between 27kg/m2 and 30kg/m2) who have additional risk factors, such as diabetes and high cholesterol. The recommended dose is one tablet three times a day, one-half hour before each meal. Although Lomaira is scheduled for launch on September 26, 2016, its pricing is not yet available. Click here for full prescribing information.

FDA Approves Invokamet XR

Invokamet® XR, (canagliflozin/metformin extended-release) tablets, a once-daily form of Janssen’s Invokamet® (canagliflozin/metformin), was approved by FDA on September 20, 2016. A fixed-dose combination sodium-glucose co-transporter 2 (SGLT2) inhibitor and extended-release metformin, Invokamet XR is indicated for the first-line treatment of adults with type 2 diabetes. Tablets will be available in four strengths -- either 50mg or 150mg of canagliflozin, and either 500mg or 1000mg of extended-release metformin. Recommended dosing is two tablets every morning along with breakfast. Because metformin may be associated with lactic acidosis, an uncommon, but serious condition, labeling for Invokamet XR includes a boxed warning. A Medication Guide will be dispensed with each prescription. No launch plans have been announced. Click here for prescribing information.

New Indications for Ilaris

FDA has granted three new indications for Ilaris® (canakinumab – Novartis). It is the first biological treatment to be FDA approved for treating familial Mediterranean fever (FMF), mevalonate kinase deficiency (MKD) and tumor necrosis factor-receptor associated periodic syndrome (TRAPS). MKD also may be called hyperimmunoglobulin D syndrome (HIDS). All three newly approved indications are for forms of the rare autoimmune disorder, periodic fever syndromes. They cause episodes of fever along with inflammation, joint and muscle pain, rashes and swelling. Ilaris originally was FDA approved in 2009 to treat patients four years of age and older who have another periodic fever syndrome, cryporin-associated periodic syndromes (CAPS). A second U.S. indication, to treat systemic juvenile idiopathic arthritis patients at least two years old, was approved in 2013. A monoclonal antibody that inhibits interleukin-1 beta (IL-1β), Ilaris is injected subcutaneously to decrease inflammation. Dosing depends on the patient’s body weight and dosing intervals depend on the condition being treated. It is dispensed in single-use vials containing 180mg of active drug after being mixed with 1mL of sterile preservative-free water. A Medication Guide supplied with Ilaris warns that patients using it have a higher than normal risk of developing serious infections. Click here for updated prescribing information. 

 
26Sep
From the CEO

From the CEO

I am excited and pleased to announce that the Foreign Service Benefit Plan (FSBP) was awarded a three-year term of accreditation by the Accreditation Association for Ambulatory Health Care (AAAHC).  Accreditation demonstrates that we have standards of quality in place and assures the public that we have made a commitment to continually enhance the quality of services and programs offered to our members and we continue to focus on the satisfaction of the members served.

Read more about our three-year accreditation, how we prepared for it, and what accreditation means to you – our members –  in our Fall newsletter that you will receive just before Open Season.

As always, thank you for your trust and for giving AFSPA the opportunity to serve you.

To Your Health,

Paula S. Jakub, RHU
CEO, AFSPA
Executive Director, Senior Living Foundation

 
23Sep

Scheduled Maintenance Notice

Please be advised that on Sunday, September 25, 2016  both www.afspa.org and www.slfoundation.org websites may be unavailable from 11:00pm - 1:00 am EDT as they will be undergoing maintenance.

Our secure Member Portal (https://secure.myafspa.org/) will not be affected by this scheduled maintenance.

We apologize for the inconvenience

 
21Sep
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Exondys 51 Approved

The U.S. Food and Drug Administration (FDA) approved Exondys 51™ (eteplirsen) injection on September 19, 2016. Exondys 51 is the first FDA-approved drug indicated to treat patients who have Duchenne muscular dystrophy (DMD). It specifically is for patients that have been confirmed to have mutations of dystrophin genes amenable to exon 51 skipping. It is given once every week as an intravenous (IV) infusion at 30mg/kg of body weight. Single-use vials contain 50mg/mL in either 2mL or 10mL sizes. Sarepta plans on launching Exondys 51 immediately. It will be available through a limited distribution network that does not include Accredo. Click here for complete prescribing information.

Exondys 51 will be added to Express Scripts’ specialty drug list. Express Scripts currently is investigating the data around Exondys 51 for a possible utilization management strategy.

Cuvitru Immune Globulin Approved

The U.S. Food and Drug Administration (FDA) approved a new immune globulin formulation on September 13, 2016. Shire’s Cuvitru [Immune Globulin Subcutaneous (Human)] 20% Solution treats primary immunodeficiency disorders including congenital agammaglobulinemia, Wiskott-Aldrich syndrome,  severe combined immunodeficiencies, common variable immunodeficiency and several others. Indicated for patients who are at least two years old, it is given subcutaneously through a portable infusion pump. Depending on the patient’s response, dosing can be as often as once a day; but some patients need only a few doses a week and others can be treated as infrequently as once every other week. When a dosing pattern is established, it should continue on a regular schedule, but adjustments in the amount of drug for each infusion are common. Cuvitru will be dispensed as 200mg/mL in single-use 5mL, 10mL, 20mL and 40mL vials. All immune globulins have a boxed warning that cautions they have the potential to cause blood clots and that advises patients to drink adequate fluids before each dose. It further recommends that the lowest effective amount be given over the minimum practical infusion time. Shire plans to release Cuvitru on the U.S. market within the next few weeks. It will be distributed by a limited network of specialty pharmacies that includes Accredo. Click here for complete prescribing information. 

Cuvitru will be added to Express Scripts’ specialty drug list. Express Scripts is reviewing the data around Cuvitru for inclusion in our Adjunctive Specialty Prior Authorization Program.

Yosprala Approved

Yosprala™ (aspirin/omeprazole) delayed-release was FDA approved on September 14, 2016. It is indicated for preventing cardiovascular events, such as heart attacks, and cerebrovascular events, such as strokes, for adults who already have had an event and who are likely to get stomach ulcers if they take aspirin. Each tablet contains 40mg of immediate-release omeprazole, a proton pump inhibitor (PPI) that protects the stomach. Either 81mg or 325mg of slow-release aspirin is included, too. The aspirin is enteric coated, so it does not dissolve in the stomach until after the omeprazole changes the levels of stomach acid. As a result, the chances of ulcer-causing damage in the stomach are reduced. Yosprala should be swallowed whole once a day an hour or more before a meal. It does not substitute for immediate-release aspirin in emergency situations and it cannot be interchanged with separate omeprazole and aspirin tablets. A medication guide for patients will be dispensed with each prescription filled. The manufacturer, Aralaz Pharmaceuticals, Inc. announced that Yosprala will be launched during the week of October 2, 2016. Click here for full prescribing information.  

Express Scripts is currently investigating the data around Yosprala for a possible utilization management strategy. 

Authorized Generic of Cubicin Launched

On September 15, 2016, Teva announced the launch of an authorized generic of Merck’s Cubicin® (daptomycin for injection), 500mg vials. Cubicin is indicated to treat adults with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of certain Gram-positive bacteria. In addition, it is indicated to treat adults with Staphylococcus aureus bloodstream infections. Annual sales of Cubicin are approximately $1.6 billion. True, A-rated generics to Cubicin are expected to launch in the near future.

 
12Sep
Clinical Matters News and Notes

Clinical Matters News and Notes

Blincyto Approved for Children

On August 30, 2016, the U.S. Food and Drug Administration (FDA) approved Amgen’s supplemental biologics license application (sBLA) for Blincyto® (blinatumomab). A bispecific CD19-directed CD3 T-cell engager, Blincyto was first FDA approved in 2014 for treating adults who have Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) that has recurred or that is no longer responding to previous treatment. FDA now has approved it for children and teens with the same type of relapsed or refractory ALL. It is dosed by weight for patients who weigh at least 45kg (99 pounds), and by body surface area (BSA) for patients who weigh less. Blincyto is given on 42-day cycles. It is infused through a continuous intravenous (IV) pump for 28 days, which is followed by 14 days with no drug. Patients should be treated in a healthcare facility for the first nine days of their first treatment cycles, and for the first two days of cycle two. Up to five cycles may be needed for a course of treatment. Labeling for Blincyto carries boxed warnings about potentially fatal neurological toxicity and cytokine release syndrome that it could cause. Additionally, its use may be associated with a number of other possibly severe side effects including infections, neutropenia, pancreatitis and tumor lysis syndrome. For complete updated prescribing information click here.

 
7Sep
Express Scripts Clinical Matters News and Notes

Express Scripts Clinical Matters News and Notes

Afluria Quadrivalent Flu Vaccine Approved

On August 29, 2016, Seqirus announced that the U.S. Food and Drug Administration (FDA) approved Afluria® Quadrivalent (influenza virus vaccine) for adults as active immunization against the two strains of influenza B as well as the two strains of influenza A that are included in the vaccine. It will be supplied in single-dose, preservative-free pre-filled syringes. Seqirus plans to launch Afluria Quadrivalent in time for the 2016-2017 flu season. Click here for full prescribing information for Afluria Quadrivalent. 
 

Expanded Arzerra CLL Indication Approved

On August 31, 2016, FDA approved Novartis’ monoclonal antibody Arzerra® (ofatumumab) for intravenous (IV) infusion in combination with fludarabine and cyclophosphamide to treat patients with relapsed chronic lymphocytic leukemia (CLL). This is the fourth CLL indication approved for Arzerra. CLL is the most common form of adult leukemia; it affects approximately 105,000 Americans – mostly over 55 years of age. Click here for updated prescribing information.
 

Generic Nitrostat Launched

On August 29, 2016, Dr. Reddy’s announced the launch of A-rated generics to Pfizer’s Nitrostat® (Nitroglycerin) sublingual tablets, a product approved for the treatment and prevention of chest pain (angina pectoris) due to coronary artery disease. Dr. Reddy’s nitroglycerin sublingual tablets are available in 0.3mg, 0.4mg and 0.6mg strengths. According to IMS Health, Nitrostat had U.S. sales of approximately $108 million for twelve months ending in March 2016.

 
2Sep

States of Emergency due to Tropical Storm Hermine – Florida, Georgia and North Carolina

The Governors of Florida, Georgia and North Carolina have declared States of Emergency due to Tropical Storm Hermine.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an emergency benefit override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide temporary alternate addresses (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed.

 
2Sep

States of Emergency due to Tropical Storm Hermine

The Governors of Florida and Georgia have declared States of Emergency due to Tropical Storm Hermine.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an emergency benefit override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide temporary alternate addresses (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed.

 
1Sep
Express Scripts Clinical Matters News Flash

Express Scripts Clinical Matters News Flash

FDA Approves Erelzi, a Biosimilar to Enbrel

On August 30, 2016, the U.S. Food and Drug Administration (FDA) approved Sandoz’s Erelzi™ (etanercept – szzs), a biosimilar to Amgen’s Enbrel®. Erelzi was approved for all Enbrel-approved indications. It can be used for treating patients with rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and polyarticular juvenile idiopathic arthritis. The dose of Erelzi varies depending on the indication. While Sandoz’s launch plans for Erelzi are unknown, it is possible that launch could be delayed two years or more due to patent litigation. Click here for full prescribing information.

  • Brand (Generic) Name: Erelzi™ (etanercept – szzs)
  • Manufacturer: Sandoz
  • Date Approved: August 30, 2016
  • Indication: Erelzi was approved for all Enbrel-approved indications. It can be used for treating patients with rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and polyarticular juvenile idiopathic arthritis.
  • Dosage Forms Available: 25mg/0.5mL and 50mg/mL solution in single-dose prefilled syringes and 50 mg/mL solution in single-dose prefilled Sensoready® Pens for subcutaneous injection
  • Launch Date: Launch plans for Erelzi are not known at this time.
  • Estimated Annual Cost: Pricing information is not available at this time.
  • Specialty Status: Erelzi will be added to Express Scripts’ specialty drug list.
  • Erelzi represents the third FDA approval for a biosimilar. Sandoz’s Zarxio® (filgrastim – sndz) was approved in March 2015, and launched in September of the same year. Pfizer and Celltrion’s Inflectra™ (infliximab – dyyb) was approved in April 2016, and launch is still pending.
  • Erelzi is not considered a generic medication nor is it considered automatically interchangeable with its innovator brand, Enbrel.
  • Erelzi is the second biosimilar tumor-necrosis factor (TNF) blocker to gain FDA approval, following Inflectra.

 

 
1Sep
From the CEO

From the CEO

Greetings and Welcome to September 2016! That means summer is almost gone and a new school year is in full swing.

We continue to update and improve our website, based in good part from member input. This time around, we have restructured the navigation flow of our website! What is new? We have grouped information, in order to improve navigation experience.

You will now be able to find information under “ALL ABOUT FSBP” related to:

• Enrollment

• Claims

• Members overseas

• Providers

• Convenience, such as Electronic Funds Transfer

• My right to know

• FSAFEDS Transition

Our new “Wellness Incentives” section covers:

• Healthy Actions

• Discount Programs

• More Wellness Programs

• myStrengthTM

There are many more changes to explore at www.afspa.org.  

Another very important and timely topic is the Federal Long Term Care Program’s (FLTCIP) increase in premiums. Many of you who have the federal plan have a major decision to make this month.  Despite the bad press, long term care insurance, in general, while admittedly very pricey, is an excellent choice to add to your financial portfolio. While the premiums seem exorbitant, they are a far cry from the $82,000 average cost of a nursing home. Members have come to us for advice and here is what we tell them:

  • If you can afford the premium increase, by all means keep the policy at the benefit level you have.
  • If you can’t afford the premium increase, then try to work with one of the Federal LTC counselors to determine what benefit level you would receive at your current premium.
  • But do try to keep the policy.  Even at the increased premium, it is far less expensive then starting over with a new policy at your current age.

Over the years AFSPA has sponsored LTC plans through three different companies – Mutual of Omaha, John Hancock, and Prudential Insurance Company of America. We contacted all three and the representatives of each company reassured us that they monitor the stability of the plans on a regular basis (not only every 7 years as is the case with the FLTCIP).  None of the companies anticipate a premium adjustment in the immediate or even near future. This is good news for our members who put their trust in AFSPA.

Read more about this topic as well as good news about the 2017 Foreign Service Benefit Plan in our Fall newsletter that you will receive just before Open Season.

As always, thank you for your trust and for giving AFSPA the opportunity to serve you.

To Your Health,

Paula S. Jakub, RHU
CEO, AFSPA
Executive Director, Senior Living Foundation

 

 
29Aug
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Abuse-Deterrent Troxyca ER Approved

Troxyca® ER, an extended-release, abuse-deterrent formulation of oxycodone and naltrexone, was approved by the U.S. Food and Drug Administration (FDA) on Aug. 19, 2016. It is a CII opioid agonist/opioid antagonist combination that is indicated for continual maintenance treatment of severe pain that has not responded to other treatment options. In Troxyca ER, naltrexone is encased in oxycodone. When swallowed, the oxycodone releases slowly over several hours. If the capsules are crushed, however, the naltrexone and oxycodone mix together, essentially cancelling any euphoric effects from the oxycodone. Although Troxyca ER is formulated specifically to limit abuse, it still carries the boxed warning on all opioids -- that taking it may be associated with abuse, addiction, misuse, overdose and death. Babies born to women who use it during pregnancy may suffer neonatal withdrawal syndrome and older children may overdose from accidentally taking it. Troxyca ER will be marketed in six strengths and it is taken at 12-hour intervals. The manufacturer, Pfizer, recommends that a healthcare provider experienced in prescribing opioids to control chronic pain should prescribe the lowest effective dose of Troxyca ER. Doses above 80mg/9.6mg should be reserved for patients who have developed tolerance to high doses of other opioids. No release date or pricing information has been announced. Click here for complete prescribing information.

 

 
26Aug

OPM Selects New FSAFEDS Contractor

As previously noted, the Office of Personnel Management (OPM) selected WageWorks, Inc. as the new Federal Flexible Spending Account Program (FSAFEDS) contractor.    

The effective day of the contract was March 1, 2016.  Transition activities are well underway and will continue until WageWorks, Inc. assumes full administration of FSAFEDS in September. This change will have no impact on enrollee balances, contributions or eligible expenses.  To find out the latest information, please go to the FSAFEDS home page.

Please send any questions and/or comments to [email protected].

 
25Aug

AFSPA Website Redesign

Greetings!

As you may have noticed, we have redesigned our website. The information has been grouped together to improve the navigation as well as to make information easier to locate.

Looking for information related to Enrollment, Claims, Providers, EFT, FSAFEDS Transition? Please check out our new "ALL ABOUT FSBP" section.

Visit our new "Wellness Incentives" to find information related to Health Risk Assessment, Healthy Actions, Discount Programs, More Wellness Programs and myStrengthmyStrengthTM

Information related to prescription costs, safety alerts, RX information and specialty medications can be located in our new "Prescription" section.

Our new "Overseas Partners" section includes information related to overseas facilities with whom we have direct billing relationships. 

Questions or Comments? Please send your feedback via our Survey:
https://www.afspa.org/secureform.cfm?formname=Feedback Survey (web)

Thank you,

Yancy Meiller

 

 
22Aug
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

MedWatch Update

Ambien

Warnings on the labels of Ambien® (zolpidem) and Ambien CR® (zolpidem extended-release) tablets have been revised to highlight their potential association with psychomotor (conscious input into movement) problems. The U.S. Food and Drug Administration (FDA) is requiring the manufacturer, Sanofi, to explain more clearly the possibility that residual effects, such as dizziness, drowsiness, slowed response time and vision changes, may interfere with driving and other tasks on the day following Ambien use. Patients taking either product to treat insomnia are cautioned that they should allow at least seven hours for sleep after taking Ambien or Ambien CR. Additionally, doses should not be repeated during the night and patients should not take doses that are higher than recommended amounts. Patients also should avoid taking certain other drugs (including some antidepressants and antifungal agents) and drinking alcohol while they are using Ambien or Ambien CR. Click here for revised prescribing information

 
18Aug

The Governor of California has declared a State of Emergency

The Governor of California has declared a State of Emergency in the following counties due to fires: Lake, San Luis Obispo and San Bernardino. 

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an emergency benefit override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide temporary alternate addresses (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed.

 
17Aug

State of Emergency due to Flooding in Louisiana

The Governor of Louisiana has declared a State of Emergency due to flooding. All counties in Louisiana are affected.  Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an emergency benefit override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide temporary alternate addresses (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed.

 
15Aug

Claim submission system temporarily down

Please be advised our claim submission system was down starting Sunday, August 14, at 12:00PM (EST) through Monday, August 15, around 11:50am (EST). If you submitted FSBP claims during these hours and are unsure if we received them or not, please feel free to contact our Member Portal (AFSPAConnect) team via the following secure form:
https://www.afspa.org/secureform.cfm?formname=Contact%20AFSPAconnect

We will confirm receipt of your claims.

Thank you,

AFSPA

 

 
15Aug
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Sustol Approved

Heron Therapeutics announced on August 10, 2016, that the U.S. Food and Drug Administration (FDA) had approved Sustol® (granisetron) extended-release injection. Sustol is indicated for preventing chemotherapy-induced nausea and vomiting (CINV) that occurs both immediately after chemo and for several days after the chemo session ends. Its patented extended-release formulation maintains therapeutic blood levels for five days or longer. A member of the serotonin-3 (5-HT3) receptor inhibitor class, it will be used in combination with other drugs, such as dexamethasone, that also help to prevent CINV. Recommended dosing for adults is 10mg given subcutaneously on the first day of chemotherapy; one-half hour or more before chemotherapy begins. It is packaged in pre-filled, single-dose syringes that should be administered by a healthcare professional. Because Sustol is thicker than most injectables, it can take up to 30 seconds to inject. Additionally, it may be more likely to cause injection site reactions such as bruises, pain and swelling – which may not appear until several days after the injection. No more than one dose should be given per week and Sustol should be used for no longer than six consecutive months. Launch is expected in the fourth quarter of 2016. Click here for prescribing information.

Keytruda Labeling Extended

Under its accelerated approval process, FDA approved a new indication for Merck’s Keytruda (pembrolizumab). On August 5, 2016, Keytruda received approval for patients who have recurring or metastatic head or neck squamous cell carcinoma (HNSCC). It is an intravenous (IV) drug that will be used during or following platinum-based therapy that is not controlling the cancer. A humanized monoclonal antibody, it blocks a protein (PD-L1), to enhance immune response. It previously was indicated for treating unresectable or metastatic melanoma and metastatic non-small cell lung cancer (NSCLC) that expresses PD-L1 and that has progressed during or after platinum-containing chemotherapy. NSCLC patients must be tested for PD-L1 before beginning Keytruda. To treat HNSCC, 200mg of Keytruda is infused over a 30-minute period once every three weeks. HNSCC patients will not need PD-L1 testing. To gain full FDA approval for HNSCC, Merck will need to conduct further studies. Click here for complete prescribing information.

MedWatch Update

PharmaTech Recall Expanded

PharmaTech is a company that manufactures multiple oral liquid medications for distribution by other companies. Many of them are over-the-counter products, such as vitamin drops and laxative syrups. In mid-July, Burkholderia cepacia (B. cepacia) bacteria were found in samples of Diocto Liquid (docusate sodium) oral solution that were made by PharmaTech and distributed by Rugby® Laboratories. PharmaTech recalled all lots of Rugby-labeled Diocto at that time. On August 8, 2016, PharmaTech extended the recall to include numerous other products distributed not only by Rugby, but also by Bayshore Pharmaceuticals, Centurion Labs, Major® Pharmaceuticals, Metron and Virtus Pharmaceuticals. B. cepacia infections usually are not serious, but they can be life-threatening for patients with lung conditions or immune system disorders. Only oral liquid dosage forms of the recalled drugs and supplements are affected by the recall. Click here for more information, including a complete list of affected products.

 

 
11Aug

Consumer Assessment of Healthcare Providers and Systems (CAHPS)

Consumer Assessment of Healthcare Providers and Systems (CAHPS) surveys ask consumers and patients to report on and evaluate their experiences with health care. These surveys cover topics that are important to consumers and focus on aspects of quality that consumers are best qualified to assess. Click here to find out what you said about FSBP.

 
8Aug

OPM Selects New FSAFEDS Contractor

The Office of Personnel Management (OPM) has selected WageWorks, Inc. as the new Federal Flexible Spending Account Program (FSAFEDS) contractor.   

 The effective day of the contract was March 1, 2016.  Transition activities are underway and will continue until WageWorks, Inc. assumes full administration of FSAFEDS in the Fall. This change will have no impact on enrollee balances, contributions or eligible expenses.  To find out the latest information, please go to the FSAFEDS home page.

 Please send any questions and/or comments to [email protected]

 
8Aug
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Dysport Approved for Children

Ipsen Biopharmaceuticals received U.S. Food and Drug Administration (FDA) approval on August 1, 2016, for a new Dysport® (abobotulinumtoxinA) indication. It already was approved for several adult conditions, including cervical dystonia and upper limb spasticity. Dysport now also can be used to treat lower limb spasticity (inflexibility, spasms or stiffness in the leg muscles) for children as young as two years old. Lower limb spasticity is fairly common for children who have cerebral palsy, head injuries, multiple sclerosis (MS), spinal cord injuries or stroke. Recommended pediatric dosing, which depends on the weight of the patient, the number of affected muscles and the severity of spasticity, is 10 units to 15 units per Kg of body weight. Dosing should not exceed 15 units/Kg per leg or 1000 units total per treatment. Injections should be given at intervals of at least 12 weeks. All botulinum toxin products, including Dysport, carry a boxed warning that they may migrate away from the areas where they are injected and possibly cause widespread side effects, such as serious breathing or swallowing problems. Migration and side effects can happen even several months after the product has been injected. Children may be especially prone to having adverse effects and Dysport should not be used for patients who are allergic to cow’s milk. Click here for complete prescribing information.

First Generic Approved for Tamiflu

The first generic for Roche’s Tamiflu® (oseltamivir) capsules was FDA approved on August 3, 2016. Oseltamivir is an oral neuraminidase inhibitor that is indicated to treat influenza (flu) for patients who are at least two weeks old and who have had flu symptoms for no longer than two days. Patients take it twice a day for five days. For periods of up to 12 weeks, it also can be used to reduce the chance of getting flu for individuals who are at high risk and who are one year old or older. According to a lawsuit settlement, the generic manufacturer, Natco Pharma, and its U.S. distribution partner, Alvogen, can launch the generic capsules prior to the expiration of Tamiflu’s last exclusivity on February 23, 2017. An exact release date has not been set, but Natco/Alvogen will have 180 days of exclusivity before other generics can enter the U.S. market. Generics for Tamiflu Oral Suspension are not yet FDA approved. IMS Health estimates that 2015 sales of Tamiflu accounted for $403 million in the United States.

Over-the-Counter Flonase Sensimist

On August 2, 2016, FDA approved GlaxoSmithKline’s request to change the marketing status of Veramyst® (fluticasone furoate, 27.5mcg) from prescription-only to over-the-counter (OTC). With the new brand name, Flonase® Sensimist™ Allergy Relief, it is labeled to treat nasal congestion, sneezing and runny nose from both seasonal and perennial allergies for patients age two and older. Patients who are at least 12 years old also can use it to manage itching, watering eyes caused by allergies. Plans are to introduce Flonase Sensimist well before the 2017 spring allergy season. Flonase® Allergy Relief Spray (fluticasone propionate, 50mcg) has been an OTC product since early 2015.

Orphan Drugs Issues Document Available

Interest in developing drug treatments for small populations of patients with rare (orphan) conditions is gaining momentum. Advancing technology, changing pharmaceutical markets, emerging advocacy groups, targeting therapies and better understanding of disease processes all have increased awareness of conditions with relatively few patients. Click here for the Orphan Drugs Issues document that discusses orphan drugs and their growing impact on pharmacy spending.

Repurposing Pharmaceuticals Issues Document Available

More drugs than ever before are being re-investigated for usefulness in treating conditions other than the ones they originally were developed to manage. By one estimate, 30% of the drugs and vaccines approved by the U.S. Food and Drug Administration (FDA) in the last few years have been repurposed in some way. Click here for the Repurposing Pharmaceuticals Issues document. 

Updated DrugWatch Document Available

The Emerging Therapeutics department has updated DrugWatch, a document that highlights near-term pipeline drugs as well as potential new generic opportunities. Click here for the DrugWatch document.

 
1Aug
From the CEO

From the CEO

Greetings and Welcome to August 2016! That means summer is winding down and a new school year is coming quickly. This is a good time to visit the pediatrician and the dentist to ensure a successful and healthy school year.

Along the same lines, please make sure your children are up-to-date on vaccines before sending them back to school. According to the Centers for Disease Control and Prevention, all school-age children need vaccines. The Foreign Service Benefit Plan (FSBP) covers immunizations recommended by the American Academy of Pediatrics at 100% when obtained at an in-network provider or providers outside the 50 Untied States. Having your child vaccinated can be important as it can affect their long-term health.

FSBP is seeking accreditation through the Accreditation Association for Ambulatory Health Care, Inc. (AAAHC). The surveyors will be onsite August 17 -19, 2016. We voluntarily requested this survey as a means of assisting our own efforts to improve the quality of health care and member services. FSBP has been preparing for the accreditation process for over a year. We are confident that our health plan will be evaluated favorably. Seeking this accreditation status is part of our ongoing “Commitment to Service” to you.

Lastly, have you moved? If so, please let us know. As you prepare to leave one post for another, please send us your new address. Your employing agency does not notify FSBP when you change your contact information. Please send a note with your updated mailing address, telephone number(s), and email address. You also can change your contact information via the Member Portal.

Look for your Summer Newsletter in the mail. It highlights AFSPA’s activities, services, and new programs, provides information on prescription drugs and offers suggestions on avoiding “ransomware” attacks. We also share some tips on how to manage stress effectively.

As always, thank you for your trust and for giving AFSPA the opportunity to serve you.

To Your Health,

Paula S. Jakub, RHU
CEO, AFSPA
Executive Director, Senior Living Foundation

 
31Jul

OPM Selects New FSAFEDS Contractor

The Office of Personnel Management (OPM) has selected WageWorks, Inc. as the new Federal Flexible Spending Account Program (FSAFEDS) contractor.    

The effective day of the contract was March 1, 2016.  Transition activities are underway and will continue until WageWorks, Inc. assumes full administration of FSAFEDS in the Fall. This change will have no impact on enrollee balances, contributions or eligible expenses.  To find out the latest information, please go to the FSAFEDS home page.

Please send any questions and/or comments to [email protected]

 
2Aug

AFSPA Open Again

AFSPA will resume normal operations at 8:30 am today. We resolved the network connectivity issues we experienced yesterday and look forward to serving you soon.

Thank you for your patience and understanding while we addressed our connectivity issues on Monday.

 
1Aug

AFSPA NETWORK DOWN

AFSPA is experiencing a network connectivity issues at our office. The issue does not affect the security of any member data only our ability to access it at this time. We are working diligently to resolve the issue. However, we have suspended phone operations for the rest of the day and are not able to respond to emails. I anticipate that network access will be restored in time for AFSPA to open our phones at 8:30 on Tuesday morning.

I sincerely apologize for this inconvenience. Thank you for your understanding and patience while resolve the issue.  

- Kyle Longton, COO

 
1Aug
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Qbrelis Approved for High Blood Pressure
On July 29, 2016, the U.S. Food and Drug Administration (FDA) approved Silvergate Pharmaceuticals’ Qbrelis™ (lisinopril oral solution) to treat high blood pressure in adults and children at least 6 years of age. It is also approved for use as an adjunct (add-on) therapy for heart failure and treatment of acute myocardial infarctions (heart attacks). Qbrelis is the first oral liquid formulation of the angiotensin-converting enzyme (ACE) inhibitor, lisinopril. It will be available in a 150 mL bottle containing 1 mg/mL of lisinopril solution. Silvergate Pharmaceuticals has not released pricing information or an expected launch date. Full prescribing information can be found here.

MedWatch Update
Fluoroquinolone Antibiotics
The FDA is strengthening its previous safety warnings for systemic (oral and injected) fluoroquinolone (quinolone) antibiotics. Some patients taking or injecting a quinolone have experienced anaphylaxis (a severe allergic reaction), intestinal infections, nerve damage, ruptured tendons, seizures, vision loss and other rare, but serious, adverse effects. Because they can cause such often irreversible problems, oral and injected quinolones generally should be reserved only for severe infections, such as anthrax and plague. The risks of using quinolones are too great for them to be used routinely for patients with uncomplicated acute bronchial, sinus and urinary tract infections. An oral or injected quinolone should only be used for uncomplicated infections when all other treatment options have failed. The FDA is requiring revisions to boxed warnings, other label sections and patient Medication Guides for ciprofloxacin (Cipro®, generics) extended-release oral tablets, oral suspension, oral tablets and solution for injection; gemifloxacin (Factive®, generics) oral tablets; levofloxacin (Levaquin®, generics) oral solution, oral tablets and solution for injection; moxifloxacin (Avelox®, generics) oral tablets and solution for injection; and ofloxacin oral tablets. Patients, caregivers and healthcare providers should be alert for symptoms, such as arrhythmias, light sensitivity, numbness, rashes and weakness in the arms or legs, among patients using a systemic quinolone. The latest FDA Safety Communication along with information from prior warnings is available here.

 
29Jul
Express Scripts News Flash

Express Scripts News Flash

Adlyxin Approved for Diabetes

Sanofi has received approval from the U.S. Food and Drug Administration (FDA) for Adlyxin™ (lixisenatide). The drug is a glucagon-like peptide-1 (GLP-1) agonist for treating adults with type 2 diabetes; it is self-administered as a once-daily subcutaneous injection. The initial dose of Adlyxin is 10mcg once daily for 14 days and then increased to 20mcg daily. Prescribing information for Adlyxin is available on the company’s website here:

  • Brand (Generic) Name: Adlyxin™ (lixisenatide)
  • Manufacturer: Sanofi
  • Date Approved: July 28, 2016
  • Indication: To improve glycemic control, along with diet and exercise, for adults who have type 2 diabetes.
  • Dosage Forms Available: 50mcg/mL (green) and 100mcg/mL (burgundy) prefilled pens. The pens are designed to deliver fourteen doses of 10mcg and 20mcg per dose, respectively.
  • Launch Date: A launch date has not been established at this time.
  • Estimated Annual Cost: Pricing information is not yet available. However, Adlyxin is expected to be priced comparable to other available GLP-1 agonists at about $5,400 per year of therapy.
  • Type 2 diabetes is the most common form of the disease affecting about 29 million people in the US; it accounts for more than 90% of diabetes cases.
  • Adlyxin is a GLP-1 agonist that moderates blood glucose levels through several pathways, including slowing glucose absorption from the gut after meals, decreasing glucagon production and promoting insulin secretion from the pancreas.
  • Once available, Adlyxin will compete with other GLP-1 agonists, including once-weekly Bydureon® (exenatide e.r. – AstraZeneca), Tanzeum™ (albiglutide – GlaxoSmithKline) and Trulicity® (dulaglutide – Eli Lilly), once-daily Victoza® (liraglutide – Novo Nordisk) and twice-daily Byetta® (exenatide – AstraZeneca). All are administered via subcutaneous injection.
  • Sanofi’s fixed-dose combination of Adlyxin and Lantus® (insulin glargine - Sanofi) is also under FDA review. The FDA is expected to rule on the approval of this product in Aug. 2016.
 
27Jul
Express Scripts Clinical Matters News Flash

Express Scripts Clinical Matters News Flash

Viekira XR Approved for Genotype 1 Hepatitis C

 

 

On July 25, 2016, the U.S. Food and Drug Administration (FDA) approved Viekira XR™, an extended-release formulation of dasabuvir/ombitasvir/paritaprevir/ritonavir tablets. It is indicated to treat adults who have chronic genotype 1 hepatitis C virus (HCV) infection. Dosing is three tablets taken once a day along with a meal. For patients who have genotype 1a HCV infection, Viekira XR will be used along with ribavirin. Recommended length of therapy for genotype 1a patients with compensated cirrhosis (Child-Pugh A) is 24 weeks; for genotype 1a patients without cirrhosis, treatment duration is 12 weeks. Patients with genotype 1b HCV infection without cirrhosis or compensated cirrhosis will take Viekira XR for 12 weeks and they will not need to use ribavirin. Patients with decompensated cirrhosis or severe liver conditions (Child-Pugh B or C) should not take it. AbbVie expects Viekira XR to be in pharmacies by the end of this week, but its cost has not yet been announced. Click here for complete prescribing information.

  • Brand (Generic) Name: Viekira XR™ (dasabuvir/ombitasvir/paritaprevir/ritonavir) extended-release tablets
  • Manufacturer: AbbVie
  • Date Approved: July 25, 2016
  • Indication: Treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1 infection (along with ribavirin for patients with genotype 1a infection without cirrhosis or with compensated cirrhosis; as monotherapy for patients with genotype 1b infection without cirrhosis or with compensated cirrhosis)
  • Dosage Forms Available: Extended-release tablets each containing 200mg of dasabuvir, 8.33mg of ombitasvir, 50mg of paritaprevir and 33.33mg of ritonavir
  • Launch Date: July 29, 2016
  • Estimated Annual Cost: Pricing information is not available at this time.
  • Specialty Status: Viekira XR will be added to Express Scripts’ specialty drug list.
  • Approximately 3.2 million Americans have HCV infection, with genotype 1 accounting for nearly 75% of cases in the U.S.
  • Genotype 1a, which is more common in the U.S., is more difficult to treat than genotype 1b.
  • Viekira XR contains dasabuvir, a non-nucleoside polymerase inhibitor; ombitasvir, an NS5A inhibitor; and paritaprevir, a protease inhibitor that is boosted with ritonavir.
  • It will be dispensed in 28-day cartons, which will include four boxes that contain a one-week supply of daily dose packs.
  • A Medication Guide that supplies patient information will accompany each prescription filled.

AbbVie’s Viekira Pak™ was approved Dec. 19, 2014. It contains ombitasvir/paritaprevir/ritonavir tablets co-packaged with dasabuvir tablets. Not including ribavirin, the dosing regimen for Viekira Pak is three tablets in the morning and one tablet in the evening compared to three tablets once daily with Viekira XR

 
25Jul
Express Scripts Clinical News And Notes

Express Scripts Clinical News And Notes

Belviq XR Approved

The U.S. Food and Drug Administration (FDA) approved Arena and Eisai’s Belviq XR® (lorcaserin), 20mg extended-release tablets, on July 15, 2016. Belviq XR is a Schedule IV controlled substance known as a serotonin 2C receptor agonist. It is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in obese adults with a body mass index (BMI) of 30 kg/m2 or greater, or overweight adults with a BMI of 27 kg/m2 or greater who have at least one weight-related comorbid condition such as high blood pressure, type 2 diabetes or high cholesterol. The recommended dose is 20mg once daily. Immediate-release Belviq®, which is taken twice daily, has been on the U.S. market since June 2013. Click here for full prescribing information.

Additional Generics to Crestor Approved

On July 19, 2016, a judge rejected AstraZeneca’s request for an order to block FDA from approving additional generics to the company’s Crestor® (rosuvastatin). Following this ruling, the agency approved generics from eight additional manufacturers. Shipments from some of the manufacturers have already begun. In 2015, U.S. annual sales of Crestor were approximately $6.4 billion.

Generic to Nilandron Launched

On July 18, 2016, ANI Pharmaceuticals announced the FDA approval of its A-rated generic to Concordia Pharms’ Nilandron® (nilutamide) 150mg tablets. Nilandron is an anti-androgen therapy indicated for use in combination with surgical castration for the treatment of patients with metastatic prostate cancer (Stage D2). The recommended dose is 300mg once daily for 30 days followed by 150mg once daily. According to IMS Health, annual U.S. sales of Nilandron are approximately $23 million. ANI launched its generic nilutamide tablets upon approval.

Generic to Zegerid and Zegerid OTC Launched

On July 18, Dr. Reddy’s announced the launch of A-rated generics to Zegerid® capsules. Zegerid contains omeprazole, a proton pump inhibitor (PPI), and sodium bicarbonate, an antacid. The medication is approved for the short-term treatment of stomach and duodenal ulcers, erosive esophagitis and heartburn associated with gastroesophageal reflux disease (GERD). Dr. Reddy’s omeprazole and sodium bicarbonate (20mg/1100mg and 40mg/1100mg) capsules are available in a 30 count bottle size. According to IMS Health, Zegerid had U.S. sales of approximately $306 million for the 12 months ending May 2016.

Perrigo also announced approval and launch of its store brand equivalent to Bayer’s Zegerid OTC® (omeprazole/sodium bicarbonate) 20mg/1100mg capsules. It will be packaged and marketed as a store brand or retailer owned brand label as a “value-priced” alternative to Zegerid OTC. Zegerid OTC is approved for the treatment of frequent heartburn. According to IMS Health, U.S. sales for Zegerid OTC were $27 million for the 12 months ending June 2016.

Berinert Approved for Use in Children

FDA approved an extension to the indications of CSL Behring’s Berinert® [C1 esterase inhibitor (human)] on July 18, 2016. Previously indicated to treat hereditary angioedema (HAE) attacks in patients 12 years of age and older, it now also is approved to treat children younger than 12. Berinert has been available in the United States since 2009. Click here for full prescribing information.

Prezista Label Expanded

Janssen announced on July 18, 2016, that the FDA has expanded the use of Prezista® (darunavir) to include pregnant women with human immunodeficiency virus (HIV). The updated label is based on an analysis of women treated with Prezista during pregnancy and postpartum, and on results from prospective reports from the Antiretroviral Pregnancy Registry. The label recommends that pregnant women receive 600mg of Prezista with ritonavir 100mg twice daily.  Prezista was originally approved in 2006 to be used in combination with other antiretroviral drugs to treat HIV. Click here for complete prescribing information.

Namzaric – Widened Indication and New Strengths Approved

The indication for Namzaric®, an extended-release capsule containing memantine and donepezil, was broadened by FDA on July 18, 2016. In addition, FDA approved two new strengths for the drug, which is taken once daily to treat dementia associated with Alzheimer’s disease. It originally received FDA approval in December 2014 for patients taking both donepezil and memantine separately for moderate-to-severe Alzheimer’s-type dementia. Namzaric now is approved for patients taking only 10mg of donepezil per day. Allergan, which markets Namzaric in the U.S., announced that the new strengths (7mg memantine/10mg donepezil and 21mg memantine/10mg donepezil) will be released in September. They join 14mg memantine/10mg donepezil and 28mg memantine/10mg donepezil capsules that already are available. The recommended initial dose for patients transitioning from donepezil monotherapy is the lowest strength capsule, increasing incrementally by 7mg memantine per week up to a maintenance dose of one highest strength capsule per day. Click here for complete prescribing information. 

Oral Form of Relistor Approved

On July 19, 2016, FDA approved Relistor® (methylnaltrexone) oral tablets. Previously available only as a subcutaneous injection, Relistor is indicated to treat opioid-induced constipation (OIC) for adult palliative-care patients who are in late stage illnesses. It has an additional approval to treat OIC for adults with chronic pain that is not caused by cancer. Valeant Pharmaceuticals International plans to launch once-a-day Relistor tablets in the third quarter of this year. Click here for prescribing information.

Expanded Indication Approved for Synjardy

On July 20, 2016, FDA approved an expanded indication for Boehringer Ingelheim and Eli Lilly’s combination product Synjardy® (empagliflozin/metformin) to include treatment-naïve adults with type 2 diabetes. The Synjardy label was updated based upon results from a phase III study comparing the combination product to the individual components. Empagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, was originally approved in 2014, while the combination product, Synjardy, was approved in 2015. Click here for full prescribing information.

MedWatch Update

Liquid Docusate

After Burkholderia cepacia (B. cepacia) bacteria were found in samples of Diocto Liquid (docusate sodium) oral solution that were tested by FDA and the Centers for Disease Control and Prevention (CDC), PharmaTech recalled all lots of Diocto on July 15, 2016. It was distributed under the Rugby® brand name. Although serious B. cepacia infections are fairly uncommon in the U.S., over 50 have been reported – mostly among patients in hospital intensive care units (ICUs) -- in the last several months. Oral docusate liquids, such as Diocto, are used widely in ICUs to help prevent constipation among patients who have limited mobility. Because other oral docusate solutions, suspensions and syrups may also contain B. cepacia, FDA and CDC are asking healthcare providers not to use any liquid docusate product until the source of the bacteria is found and eliminated. Other dosage forms of docusate (capsules, enemas and tablets) are not associated with B. cepacia contamination. Click here for more information about the PharmaTech recall.

Updated Patent Expiration Report Available

The Emerging Therapeutics Department has updated its patent expiration document. Click here for the updated patent expiration document.

 
19Jul
Express Scripts Clinical News And Notes

Express Scripts Clinical News And Notes

New Once-Monthly Formulation of Repatha Approved

On July 11, 2016, Amgen announced U.S. Food and Drug Administration (FDA) approval of its Repatha® (evolocumab) Pushtronex™ system, a product to deliver a monthly single-dose of Repatha. The Pushtronex system is a hands-free, on-body infuser device designed to subcutaneously administer 420mg of Repatha as a single dose over nine minutes. Repatha also is available as 140mg single-use prefilled syringes and SureClick® autoinjectors. Prior to the Pushtronex system, the single monthly dose required injection with three 140mg syringes. Repatha is also approved with a dosing schedule of 140mg subcutaneously every two weeks. Amgen is expected to launch the Repatha Pushtronex system in early August 2016. Click here for full prescribing information.  

Expanded Indication for Dexilant

Takeda announced that on July 11, FDA approved an expanded indication for Dexilant® (dexlansoprazole), a proton pump inhibitor (PPI) for treating stomach acid-related disorders. Dexilant is now indicated for treating gastroesophageal reflux disease (GERD) and healing of erosive esophagitis (EE) in patients 12 years of age and older. Previously, it was indicated for use in individuals at least 17 years of age. Click here for full prescribing information.

Expanded Approval for Prevnar 13

On July 11, 2016, FDA approved a wider patient population for Pfizer’s pneumonia vaccine, Prevnar 13® (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]). Previously approved by the FDA for adults age 50 and older and for children 6 weeks to 18 years old, Prevnar 13 now is indicated for all individuals over six weeks of age. It protects against 13 strains of Streptococcus pneumoniae (also called pneumococcus) bacteria, which are major causes of pneumonia and several other infections. Babies should receive doses of the vaccine at two months, four months and six months of age. A fourth dose should be given when the child is between 12 months and 15 months old. Children over age five, adolescents and adults need only one injection. Prevnar 13 is supplied in pre-filled, single-dose syringes for administration by a healthcare professional. Click here for complete prescribing information.

MedWatch Updates

Docusate Oral Solution, Oral Suspension and Syrup

As of July 14, 2016, the U.S. Centers for Disease Control and Prevention (CDC) had identified over 50 cases of Burkholderia cepacia complex (B. cepacia) bacterial infections in at least five states. Although harmless for most individuals, B. cepacia infections can be severe for patients who are immunocompromised or already seriously ill. Cystic fibrosis patients are especially prone to having lung infections caused by it. Most patients affected by the current outbreak were given a liquid form of the stool softener, docusate, while they were being treated at intensive care units (ICU) of several different hospitals. CDC and FDA believe that contaminated docusate liquid may be causing the infections. Other forms of docusate (oral capsules, oral tablets and rectal enemas) are not believed to be affected. CDC is asking healthcare providers not to give patients any liquid docusate products. All new cases of B. cepacia should be reported to public health officials and all liquid docusate that might be involved should be collected and saved to be tested for contamination. For more information, please click here

Alere INRatio

Alere, Inc. announced on July 11, 2016, that it is withdrawing from the U.S. market all of its INRatio® and INRatio®2 PT/INR monitoring systems. PT (prothrombin time) and INR (international normalized ratio) measure how long blood takes to clot. Target INR values for patients taking anticoagulant medications are between 2.0 and 3.0 INR units. Values above 4.5 units increase the risk of excessive bleeding. In December 2014, Alere advised that some systems under reported INR by up to 12.2 INR units when compared to plasma INR testing done by a laboratory. Readings for patients with several conditions, including anemia, cancer, end-stage kidney disease, acute or chronic infections and inflammatory disorders, were particularly likely to be incorrect. Nine serious adverse events related to using the systems prompted a recall at that time. Since then, Alere has worked with FDA to make changes that prevent the errors. However, no workable solution has been found and Alere has decided to discontinue the devices. It will inform providers and patients of alternative monitoring options as it phases out the INRatio line. For more information about the withdrawal, please click here.

Updated DrugWatch Document Available

The Emerging Therapeutics department has updated DrugWatch, a document that highlights near-term pipeline drugs as well as potential new generic opportunities. Click here for the updated DrugWatch document. 

 

 
13Jul
Express Scripts Clinical Matters News Flash

Express Scripts Clinical Matters News Flash

Xiidra Approved for Dry Eyes

On July 12, 2016, the U.S. Food and Drug Administration (FDA) approved Shire’s Xiidra™ (lifitegrast ophthalmic solution) 5% for treating the signs and symptoms of dry eye disease. The recommended dose is one drop in each eye administered twice daily, approximately 12 hours apart. Shire announced plans to launch Xiidra within the next few months (3rd quarter 2016). Click here for full prescribing information.

  • Brand (Generic) Name: Xiidra™ (lifitegrast ophthalmic solution) 5%
  • Manufacturer: Shire
  • Date Approved: July 12, 2016
  • Indication: Treatment of the signs and symptoms of dry eye disease
  • Dosage Forms Available: Xiidra will be available in foil pouches containing five 0.2mL single-use containers.
  • Launch Date: 3rd Quarter 2016
  • Estimated Annual Cost: Xiidra is expected to cost approximately $3,600 per year of therapy, similar to Restasis® (cyclosporine ophthalmic emulsion – Allergan).
  • Specialty Status: Lifitegrast is a lymphocyte function-associated antigen (LAF-1) antagonist. It works by down-regulating inflammation mediated by T lymphocytes, a type of white blood cell. Inflammation of the eye can cause a decrease in tear production, leading to dry eye disease.
  • Xiidra is a potential blockbuster medication. It will primarily compete with Allergan’s Restasis, a product with approximately $1.6 billion in annual sales. Restasis was originally approved in Dec. 2002 for increasing tear production in patients with dry eyes due to underlying ocular inflammation.
  • Xiidra was approved ahead of its July 22, 2016, PDUFA date. This is the second time Xiidra was under FDA review. It was issued a “complete response” letter in October 2015 as FDA requested additional data to support approval.  
 
11Jul
Express Scripst Clinical News and Notes

Express Scripst Clinical News and Notes

Syndros Oral Solution Approved

Insys Therapeutics received approval from the U.S. Food and Drug Administration (FDA) for Syndros™ (dronabinol) oral solution, a cannabinoid medication indicated to treat adults with anorexia associated with weight loss in patients with AIDS and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. The recommended doses and frequencies differ according to the condition being treated and the patient’s ability to tolerate the drug. Insys will launch Syndros after the Drug Enforcement Agency (DEA) completes its controlled substance scheduling review, likely in late 2016 or early 2017. Once available, it will compete with Marinol® (dronabinol capsules, CIII – Solvay/generics) for market share. Click here for full prescribing information. Express Scripts is currently evaluating the data around Syndros for a possible utilization management strategy.

 

Expanded Indication Approved for Xolair

On July 7, 2016, the FDA approved Genentech’s Xolair® (omalizumab) to treat moderate to severe allergic asthma in patients six years of age and older who are inadequately controlled with inhaled corticosteroids. Previously, Xolair was approved for this indication in patients 12 years of age and older. Xolair, a biologic drug that is administered by subcutaneous injection, has been on the market since 2003. It is also indicated to treat chronic idiopathic urticaria in patients 12 years of age and older who have symptoms despite treatment with an H1 antihistamine. Click here for full prescribing information.

 

Differin Gel Approved for Over-The-Counter Sale

The FDA announced on July 8, 2016, the approval of Differin Gel 0.1% (adapalene), a once-daily topical gel for over-the-counter (OTC) treatment of acne in people 12 years of age and older. Acne affects nearly 50 million people in the United States, and Differin Gel 0.1% is the first retinoid acne treatment available OTC. Differin Gel was originally approved in 1996 for patients 12 years of age and older with acne vulgaris. Galderma is planning to launch Differin Gel 0.1% OTC in the near future; however, at this time there is no specific launch date. Pricing is not yet known.

 

Generic to Fenoglide Available

Mylan announced the launch of its A-rated generics to Santarus' Fenoglide® (fenofibrate) 40mg and 120mg tablets. Fenoglide, a peroxisome proliferator receptor alpha (PPARα) activator, is indicated for use in combination with a low-cholesterol diet to help lower triglycerides, total cholesterol, low-density lipoprotein (LDL) cholesterol, and apolipoprotein B (apo B). Additionally, it may help to increase high-density lipoprotein (HDL) cholesterol, or “good” cholesterol. This marks the first launch of a true generic to Fenoglide. In June 2015, Globe Pharmaceuticals launched “authorized generics” to Fenoglide 40mg and 120mg tablets. Authorized generics are essentially brand drugs repackaged into generic-looking bottles and can compete as either brand or generics, depending on the market dynamics. For the 12 months ending on April 30, 2016, fenofibrate 40mg and 120mg tablets sales were approximately $28.3 million according to IMS Health.

 
5Jul
Express Scripts Clincial News and Notes

Express Scripts Clincial News and Notes

Humira Approved for Panuveitis

On June 30, 2016, AbbVie announced that the U.S. Food and Drug Administration (FDA) approved Humira® (adalimumab) for the treatment of non-infectious intermediate, posterior and panuveitis. In 2014, FDA granted Humira orphan drug designation for this indication. Uveitis is an inflammatory eye disease that can flare and impact vision. Uveitis is typically treated with corticosteroids. Recommended dosing of Humira for uveitis is 80mg, followed by 40mg every other week by subcutaneous injection. Humira is a tumor necrosis factor (TNF) inhibitor that was first approved in December 2002. It is also indicated to treat nine other inflammatory conditions including rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis, ankylosing spondylitis, Crohn’s disease (in adults and children), ulcerative colitis, psoriasis and hidradenitis suppurativa. For full prescribing information click here.

Updated Hepatitis C Issues Document Available

The standard of care for treating chronic hepatitis C (CHC) is rapidly evolving. The Infectious Diseases Society of America (IDSA) and the American Association for the Study of Liver Diseases (AASLD) in collaboration with the International Antiviral Society-USA (IAS-USA) provides web-based, evidence-based, expert-derived recommendations for hepatitis C management. The guidance is a fluid document, updated as the treatment landscape evolves and new therapies are approved. This Issues Document is intended to describe current and pipeline medications for treating hepatitis C and how Express Scripts and Accredo can effectively manage the evolving market. Click here for the Hepatitis C Issues Document.

 
1Jul
From the CEO

From the CEO

Greetings and Welcome to July 2016! That means summer is in full swing and we are enjoying the seasonal activities. As you travel and see the sites, you can take comfort in knowing AFSPA is Caring for your Health Worldwide®.

July is the month we celebrate Independence Day. The Fourth of July commemorates the adoption of the Declaration of Independence on July 4, 1776. Throughout the year, our members represent the United States and work to protect and promote the ideals embodied in our founding document. On this holiday, wherever you are in the world, I hope you can celebrate our country’s history and heritage.

Also, July is National Minority Mental Health Awareness Month. It is a time to focus on the importance of mental wellness and effective mental health care for everyone. It is also when we can make others aware of available resources. The Foreign Service Benefit Plan (FSBP) offers many benefits to address your mental health needs including Digital Coaching, Health Coaching, and myStrength™ - the online mental health support program. To learn more, see pages 83 – 86 of the Plan Brochure.

Lastly, I encourage you to maintain a healthy diet all year round. Attending summer barbeques and family reunions can invite temptations to eat unhealthy foods. But try to eat fruits and vegetables with every meal and snack. They can help your body fight off sickness. Plus, they can give you energy and help you stay at a healthy weight. When you do give into temptation, remember moderation is key.


Once again, please enjoy your friends and family on the Fourth of July. As always, thank you for your trust and for giving AFSPA the opportunity to serve you.

To Your Health,
Paula S. Jakub, RHU
CEO, AFSPA
Executive Director, Senior Living Foundation

 

 
1Jul
Member Portal Outage

Member Portal Outage

AFSPA is experiencing an outage of its AFSPAconnect Member Portal. We are working to resolve the issue and will have it operational again as soon as possible. There may be periodic interruptions to the AFSPA.org site throughout the day as well. I anticipate that these will be temporary.

The outage also is affecting staff access to certain parts of our network. This may lead to a delay in response time to e-mails and a longer hold time for callers.

I apologize for the inconvenience and appreciate your patience.

-Kyle Longton

 

 
29Jun
Early Closing on July 1

Early Closing on July 1

AFSPA will close at 3 pm EDT on Friday, July 1. We will remain closed through the Independence Day holiday on Monday, July 4. We will resume our normal business hours at 8:30 am EDT on Tuesday, July 5.

We wish all of our members and their families a safe and fun Independence Day!

 
28Jun

State of Emergency as a result of floods

The governors of West Virginia and Virginia have declared States of Emergency in the certain counties due to flooding. Express Script’s (the Plan’s Pharmacy Benefit Manager) has activated an emergency benefit override that allows pharmacies, at the point of sale (POS), to override select benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide ESI a temporary alternate address (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed.  The following counties are affected by this:
 

·         West Virginia impacted counties: Barbour, Boone, Braxton, Cabell, Calhoun, Clay, Doddridge, Fayette, Gilmer, Greenbrier, Harrison, Jackson, Kanawha, Lewis, Lincoln, Logan, Marion, Mason, McDowell, Mercer, Mingo, Monongalia, Momoe, Nicholas, Pendleton, Pleasants, Pocahontas, Preston, Putnam, Raleigh, Randolph, Ritchie, Roane, Summers, Taylor, Tucker, Tyler, Upshur, Wayne, Webster, Wetzel, Wirt, Wood, and Wyoming Counties.

·         Virginia impacted county: Alleghany

 
27Jun
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Rayaldee Approved for Secondary Hyperparathyroidism

On June 17, 2016, OPKO Health received U.S. Food and Drug Administration (FDA) approval of Rayaldee® (calcifediol) extended-release capsules for the treatment of secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease and with serum total 25-hydroxyvitamin D levels less than 30ng/mL. The initial recommended dose is 30mcg once daily at bedtime, which can be increased to 60mcg after three months if intact parathyroid hormone is above the treatment goal. OPKO Health plans on launching Rayaldee in the second half of 2016; it will be available as 30mcg extended-release capsules. Click here for full prescribing information.

 

 

Avycaz Labeling Extended

On June 22, 2016, FDA approved Allergan’s request to add information from a Phase III study to the labeling for Avycaz® (ceftazidime/avibactam). It is an intravenous (IV) drug that includes two kinds of antibacterials; one is a cephalosporin and one a beta-lactamase inhibitor. Avycaz was first approved in February 2015 to be used after other antibacterial treatments had failed for patients with complicated urinary tract infections caused by certain bacteria. At the same time, Avycaz received FDA approval, in combination with metronidazole, to treat patients with complicated intra-abdominal infections that also are due to specific microorganisms. Based on the results of the study, Avycaz labeling now can include information about its effectiveness against more types of bacteria that cause complicated intra-abdominal infections. Click here for complete prescribing information.

 
20Jun
Express Scripts News and Notes

Express Scripts News and Notes

Vaxchora Vaccine Approved to Prevent Cholera

On June 10, 2016, the U.S. Food and Drug Administration (FDA) approved PaxVax’s Vaxchora™, a vaccine for prevention of cholera caused by serogroup O1 in adults age 18 through 65. Cholera is an acute intestinal infection characterized by diarrhea acquired by ingesting contaminated water or food. The majority of cases are associated with foreign travel to endemic areas where the water and food supply is contaminated. Vaxchora is the only vaccine approved in the U.S. for protection against cholera. It will be supplied as an oral, single-dose, live attenuated vaccine that should be administered at least 10 days before travel to a cholera-affected area. The vaccine is expected to be available in the third quarter of 2016. Click here for full prescribing information. 

 

 

Gonitro Approved for Angina Pectoris

Espero Pharmaceuticals received FDA approval for Gonitro™ (nitroglycerin) sublingual powder for the acute relief of an attack or prophylaxis of angina pectoris (chest pain) due to coronary artery disease. It will be available as packets, each containing 400mcg of nitroglycerin. The recommended dose is one or two packets under the tongue at the onset of an angina attack. One additional packet can be administered every 5 minutes as needed, not to exceed three packets within a 15 minute period. If chest pain persists after the administration of three packets, the patient should seek medical attention. Gonitro can also be used to prevent chest pain prior to engaging in activities that could provoke an acute angina attack. It represents another treatment option for the estimated eight million Americans who suffer with stabile angina due to coronary artery disease. Espero plans on launching Gonitro during the second half of 2016. Click here for full prescribing information.

 

New Strength for Orfadin

A higher strength of Sobi’s Orfadin® (nitisinone) was approved by FDA on June 15, 2016. It is indicated for the treatment of Hereditary Tyrosinaemia type-1 (HT-1), a rare and progressive disease that results in potentially fatal liver and kidney complications. Orfadin was initially approved in 2002. The new 20mg capsule is expected to launch in September 2016. The drug is also available as 2mg, 5mg, and 10mg capsules, and as a 4mg/mL oral suspension. Click here for full prescribing information.

 

Glassia Approved for Self-Infusion

On June 15, 2016, Shire and Kamada announced that FDA approved Glassia for self-infusion at home after appropriate training. Glassia, which was originally approved in 2010, is an alpha1-proteinase inhibitor to treat the chronic, genetic disorder alpha1-antitrypsin (AAT) deficiency. AAT deficiency can lead to the destruction of lung tissue and cause chronic lung disease such as emphysema. The recommended dose of Glassia is 60mg/kg administered by intravenous infusion once weekly. Click here for full prescribing information.

 

MedWatch Updates

Zecuity

Updating a safety notice that it issued earlier in June, FDA announced on June 10, 2016, that Teva Pharmaceuticals temporarily is suspending marketing, sales and distribution of Zecuity® (sumatriptan iontophoretic transdermal system) patches. Since Zecuity was launched in the U.S about 10 months ago, FDA and Teva have received multiple reports of reactions – primarily burns and scars – at the sites where patches have been applied. While they jointly investigate the adverse reactions, Teva recommends that patients stop using Zecuity, dispose of any unused patches they may have and request a different migraine drug from their physicians. Providers not only should stop prescribing Zecuity, they should advise patients to stop using it, as well. Patients who may have had reactions should be evaluated by their doctors. Those with injuries caused by Zecuity should file a MedWatch report with FDA. MedWatch forms may be requested by phone at 800.332.1088 or click here to download.

 

Teva Migraine Support Solutions can provide instructions regarding disposal of unused patches at 855.932.8489. Click here for the updated FDA notice regarding the Zecuity marketing suspension.

 

Invokana/Farxiga
Following up on another previous Safety Communication, FDA announced on June 13, 2016, that it is requiring stronger warnings for the sodium-glucose cotransporter-2 (SGLT2) inhibitors, Invokana® (canagliflozin), Farxiga™ (dapagliflozin) and their combination products, Invokamet® (canagliflozin/metformin) and Xigduo™ XR (dapagliflozin/metformin extended release). All four are indicated to treat type 2 diabetes. Over about two and one-half years, FDA verified at least 100 cases of acute kidney injury (AKI) among patients taking one of the drugs. Most recovered at least partly after the drug was stopped, but four patients died and several others had to undergo dialysis. Labeling for the drugs now includes advice for patients to report any signs of AKI, such as decreased urine output or swollen legs, to their doctors. Prescribers are cautioned to assess kidney functioning before prescribing one of the drugs and then to reassess patients regularly, watching for any possible AKI symptoms. Click here for more information.

 
13Jun
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Byvalson Approved to Treat High Blood Pressure

Byvalson™ (nebivolol/valsartan) was approved by the U.S. Food and Drug Administration (FDA) on Jun. 3, 2016. It is indicated for lowering high blood pressure. Each tablet contains 5mg of a beta blocker (nebivolol) and 80mg of valsartan, an angiotensin II receptor blocker (ARB). Taken once daily, Byvalson can be used either as first-line treatment or for patients whose high blood pressure is not managed adequately by taking either nebivolol or valsartan alone. It also may be taken along with drugs from other classes, such as diuretics. Labeling for Byvalson has a boxed warning against using it during pregnancy because the ARB component may cause fetal death or birth defects that could include bone, kidney or lung damage. The manufacturer, Allergan, plans to release Byvalson during the second half of 2016. Click here for full prescribing information.

 

 

Express Scripts is currently investigating the data around Byvalson for a possible utilization management strategy.

 

New Formulation of Jetrea Approved

ThromboGenics NV received FDA approval for a new formulation of its already approved drug Jetrea® (ocreplasmin) for the treatment of vitreomacular adhesion (VMA). The new formulation of Jetrea will come as an already-diluted version, eliminating the previously required preparatory dilution steps prior to injection. Jetrea was originally approved in 2012 for the treatment of VMA. Jetrea is administered by intravitreal (eye) injection as a one-time dose. It is the only pharmacological treatment approved for treatment of VMA. ThromboGenics plans to launch the new formulation in the first half of 2017. Click here for full prescribing information.

 

Generic to Dofetilide Capsules Launched

Mayne Pharma announced the launch of its generic alternative to Pfizer’s Tikosyn® (dofetilide) 125mcg, 250mcg and 500mcg capsules. The company was granted 180 days of generic exclusivity.  Tikosyn is an anti-arrhythmic agent used to prevent irregular heartbeats, including atrial fibrillation and atrial flutter. According to IMS health, annual U.S. sales of Tikosyn are approximately $200 million.  

 

Updated DrugWatch Document Available

The Emerging Therapeutics department has updated DrugWatch, a document that highlights near-term pipeline drugs as well as potential new generic opportunities. Click here for the updated DrugWatch document. 

 
6Jun
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Jentadueto XR Approved for Type II Diabetes

The U.S. Food and Drug Administration (FDA) approved Boehringer Ingelheim and Eli Lilly’s Jentadueto® XR on May 31, 2016. The product is a once-daily fixed dose combination of the dipeptidyl peptidase-4 (DDP-4) inhibitor, Tradjenta® (linagliptin), and extended-release metformin. Jentadueto XR is approved for use in adult patients with type 2 diabetes where treatment with both linagliptin and extended-release metformin is appropriate. It will be available in two strengths (linagliptin/metformin e.r.) 5mg/1000mg and 2.5mg/1000mg. Boehringer Ingelheim and Lilly plan on launching Jentadueto XR in mid-to-late July. Click here for complete prescribing information.

 

Juvéderm Volbella XC Approved

On June 1, 2016, Allergan announced the FDA approval of Juvéderm Volbella® XC for use in lip augmentation and for correction of perioral lines (lines around the lips) in adults 21 years of age and older. Juvéderm Volbella XC contains a hyaluronic acid gel formulation that is designed to add volume to the lips and soften perioral lines. Allergan plans on launching Juvéderm Volbella XC in October 2016. Click here for more information.

 

Generic to Doryx 50mg Delayed-Release Tablets Launched

Mylan announced the launch of its A-rated generic alternative to Mayne Pharma’s Doryx® (doxycycline hyclate delayed-release) 50mg tablets. The company was granted 180 days of generic exclusivity preventing FDA from approving additional generics to this strength until November 2016. Doryx is a tetracycline antibiotic that is used for a variety of conditions including acne, respiratory tract infections and sexually transmitted infections. According to IMS Health, annual U.S. sales of Doryx 50mg tablets are approximately $21.8 million.

 

Expanded Teflaro Indication Approved

On May 31, 2016, Allergan received approval from the FDA for Teflaro® (ceftaroline fosamil) as a treatment for acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP) for patients aged 2 months to younger than 18 years. Teflaro was first approved as a treatment for ABSSSI and CABP for adults in October 2010. Teflaro is the only cephalosporin antibiotic with activity against methacillin-resistant Staphylococcus aureus (MRSA) in ABSSSI. Click here for full prescribing information.

 

MedWatch Update

Zecuity

In a Drug Safety Communication released Jun. 2, 2016, FDA warned of possibly severe side effects from using Zecuity® (sumatriptan iontophoretic transdermal system – Teva Pharmaceuticals). Introduced in the United States last September to treat migraine headaches, Zecuity uses a weak electric current to deliver sumatriptan through the skin. FDA has received numerous reports from patients who have suffered burns or who have scars, some apparently permanent, from the patches, even though they were used according to directions. While it analyzes available data further, FDA advises a patient who uses a Zecuity patch and who has pain at the place where the patch is applied to take it off at once and contact a healthcare provider. The disposable patches, which each include batteries, should not get wet during use. Patients also are reminded to use each Zecuity patch for only four hours or less. Some patients may need to ask their prescribers about changing to another migraine medication.

 
2Jun
Express Scripts Clinical Matters News Flash

Express Scripts Clinical Matters News Flash

Generic Nuvigil Launched

 

Mylan announced the launch of its AB-rated generic to Cephalon's Nuvigil® (armodafinil) 50mg, 150mg and 250mg tablets. The drug, a stimulant medication, is approved to treat sleepiness from narcolepsy, sleep apnea, or night shift work. Mylan was granted 180 days of generic exclusivity for these strengths of Nuvigil, preventing FDA from approving additional generics until December 2016.

  • Brand (Generic) Name: Nuvigil® (armodafinil - Cephalon)
  • Generic Manufacturer: Mylan
  • Launch Date:  June 1, 2016
  • Indication: To improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea, narcolepsy, or shift work disorder.
  • Dosage Forms Available: 50mg, 150mg and 250mg tablets
  • Annual U.S. Sales: $489.7 million for the most recent 12 months ending in March 2016 according to IMS Health.
  • Later today, Allergan is expected to announce the launch of its AB-rated generic to Nuvigil 200mg tablets with 180 days of generic exclusivity.
  • Nuvigil is a single isomer follow-on to the company’s Provigil® (modafinil). Generics to Provigil became available in March 2012. 
 
1Jun
Express Scripts Clinical Matters News Flash

Express Scripts Clinical Matters News Flash

Ocaliva Approved for Primary Biliary Cholangitis

 

On May 27, 2016, the U.S. Food and Drug Administration (FDA) approved Intercept Pharmaceuticals’ Ocaliva™ (obeticholic acid). Ocaliva is indicated to treat primary biliary cholangitis (PBC), a slowly progressing autoimmune liver disease caused by the destruction of bile ducts. Ocaliva stimulates farnesoid X receptors (FXR), which helps to limit the production of bile acids and also increases bile flow out of the liver. It is indicated for adult patients whose PBC has not improved adequately after at least one year of treatment with ursodeoxycholic acid (UDCA). Recommended dosing is 5mg once daily along with UDCA or by itself for patients who cannot take UDCA. Intercept plans on launching Ocaliva in early June. It will be available through a limited network of specialty pharmacies that includes Accredo. Complete prescribing information for Ocaliva is at: https://ocaliva.com/ocaliva_pi.pdf.

  • Brand (Generic) Name: Ocaliva™ (obeticholic acid)
  • Manufacturer: Intercept Pharmaceuticals
  • Date Approved: May 27, 2016
  • Indication: To treat primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA
  • Dosage Forms Available: 5mg and 10mg oral tablets
  • Launch Date: By June 8, 2016
  • Estimated Annual Cost: Based on wholesale acquisition cost (WAC), Ocaliva will cost approximately $68,400 per year.
  • Specialty Status: Ocaliva will be added to Express Scripts’ Specialty drug list.
  • Previously called primary biliary cirrhosis, PBC is an inflammatory autoimmune condition that destroys bile ducts. As a result, bile gradually accumulates in the liver, eventually causing irreversible liver damage. PBC is a major cause for liver transplants.
  • PBC affects only a small number of U.S. patients, but its onset is gradual, so most patients typically are not diagnosed with it until after the age of 35. Between 75% and 90% of patients are women.
  • Until the approval of Ocaliva, the only drug FDA approved to treat PBC was ursodeoxycholic acid (UDCA). In the United States, UDCA has the generic name ursodiol and the brand names Actigall® (300mg capsules – Actavis) and Urso Forte® (500mg tablets – Actavis).
  • Obeticholic acid is also a breakthrough therapy for the treatment of nonalcoholic steatohepatitis (NASH) in patients with liver fibrosis. Approval for this expanded indication is expected in 2018.

Zinbryta Approved for Multiple Sclerosis

The U.S. Food and Drug Administration (FDA) approved Biogen and AbbVie’s Zinbryta™ (daclizumab) on May 27, 2016. It is indicated for treating adults who have relapsing forms of multiple sclerosis (MS). However, it should generally be reserved for patients who have had an inadequate response to two or more drugs for treating MS. The recommended dose is 150mg given by subcutaneous injection once every four weeks. Zinbryta was approved with a Risk Evaluation and Mitigation Strategy (REMS), which includes required monthly liver function tests and a restricted distribution program. AbbVie plans on launching Zinbryta within a few weeks. It will be available through a limited network of specialty pharmacies that includes Accredo. Full prescribing information can be found at: https://www.zinbryta.com/.

  • Brand (Generic) Name: Zinbryta™ (daclizumab)
  • Manufacturer: Biogen and AbbVie
  • Date Approved: May 27, 2016
  • Indication: To treat adult patients with relapsing forms of multiple sclerosis (MS) who have had an inadequate response to two or more MS therapies
  • Dosage Forms Available:  Self-administered autoinjector containing 150mg of Zinbryta for subcutaneous administration
  • Launch Date: AbbVie plans on launching Zinbryta within a few weeks.
  • Estimated Annual Cost: Pricing information is not yet available.
  • Specialty Status: Zinbryta will be added to Express Scripts’ specialty drug list.
  • MS is an autoimmune condition that destroys myelin sheaths (protective coverings on nerve cells in the brain and spinal cord). About two-thirds of patients are women and most patients are diagnosed between 20 years and 50 years of age.
  • The most common form, relapsing-remitting MS (RRMS), affects about 85% of about 400,000 Americans who have the disease. Patients with RRMS have periods of active symptoms alternating with remissions ? periods of little or no disease activity.
  • An intravenous (IV) form of daclizumab, under the brand name of Zenapax®, was previously on the market for preventing the rejection of kidney transplants. However, it was withdrawn from the U.S. market in 2009 because of low sales.
  • Zinbryta is an interleukin-2 receptor blocking antibody that helps to reduce T-cell overactivity in patients with MS.
  • Zinbryta’s labeling has a boxed warning, highlighting the potential for autoimmune liver damage or other immune-related conditions. Patients using it will need liver function testing on a monthly basis.
  • Zinbryta’s prescribers, dispensing pharmacies and patients all will be authorized under a Risk Evaluation and Mitigation Strategy (REMS). 
 
1Jun
FROM THE CEO

FROM THE CEO

Welcome to Summer 2016! In many parts of the world, this means transitioning from cooler weather to warmer weather. Please use sunscreen while enjoying the nice weather. There are many dangers that come from too much sun exposure including premature aging, sunburn, and skin cancer. The World Post reports that globally, skin cancer is the fifth most common cancer for men and seventh for women. Sunscreen shields your skin from the risk of various types of skin cancer. Please use it throughout the summer season.

By now, you should have seen the Spring AFSPA in Action Newsletter in your mailbox. We have received wonderful feedback about the first ever spring newsletter. The two sections that I hope you pay special attention to are Living Well Together and AFSPA Listens. On pages 6 and 7, members can learn how to match specific health conditions to FSBP services. It explains FSBP programs and how they can meet your individual needs. Then, COO Kyle Longton responds to member questions and concerns on page 10. The article explains our handling of some of your most difficult situations. Because it is so important for us to respond to our members’ issues, I have asked Kyle to make this a permanent section in our newsletter going forward. 

Also, please be advised we have deployed security enhancements to the claims processing in the Member Portal. FSBP members will no longer see a hyperlink in your secure Member Portal. You now will see a link that allows you to download the claims you would like to see. In order to view the claims, you must be logged into your secure Member Portal. If you attempt to go to a hyperlink for a claim, without being logged in, you will be presented with an error message. Then you will be redirected to the login page. The same happens if you copy and paste into a different browser. Please call a Health Benefits Officer if you have any questions about any of the new security enhancements. Our goal is to keep your information safe.

Lastly, summertime means summer travel. Whether you travel domestically or internationally, you may want to consider a travel insurance plan. Please also consider this insurance plan for visiting family members, especially those who visit you overseas.  Many commercial health plans and even Medicare, do not provide coverage for service received overseas. A travel insurance plan can provide assistance such as: an emergency cash advance, luggage tracking, referrals to physicians and hospitals, payment for medical claims, emergency evacuation, repatriation of remains, or something as simple as information regarding the weather. AFSPA offers a 24-hour global assistance and travel insurance policy through Travel Assistance International. If you travel frequently, you can purchase the plan on an annual basis or on a per trip basis. See the full description of services that are provided as well as an application on the AIP section of AFSPA’s website.  

We hope your family stays safe and healthy this summer. As always, thank you for your trust and for giving AFSPA the opportunity to serve you.

To Your Health,
Paula S. Jakub, RHU
CEO, AFSPA
Executive Director, Senior Living Foundation

 
31May
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Buprenorphine Implant Approved

On May 26, 2016, the U.S. Food and Drug Administration (FDA) announced it had approved Probuphine® (buprenorphine) implant for subdermal administration, CIII, as maintenance treatment of opioid dependence. Four small Probuphine rods are implanted under the skin inside the upper arm by a healthcare provider who is trained and certified. The rods must be removed after six months or if they shift, cause irritation or become infected. Unlike the sublingual and buccal forms of buprenorphine that currently are available, Probuphine releases drug slowly over six months. Patients eligible for using it will have to be stabilized on low or moderate doses (no more than 8mg per day) of sublingual or buccal buprenorphine. The manufacturers, Titan Pharmaceuticals and Braeburn Pharmaceuticals, have not shared pricing details, but have indicated that Probuphine will cost less than $6,000 per implantation. The companies plan on launching the drug this summer. The product labeling contains a boxed warning cautioning about possible nerve damage caused by the implants, as well as about potential movements of the rods after implantation. Complete prescribing information is at:

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204442Orig1s000lbl.pdf

 

 

Flucelvax Quadrivalent Approved

On May 24, 2016, the U.S. Food and Drug Administration (FDA) approved Flucelvax Quadrivalent™ (influenza virus vaccine) suspension for intramuscular injection as active immunization against the two strains of influenza A as well as the two strains of influenza B that are included in the vaccine. The quadrivalent formula is the first four-strain cell structure-derived inactivated influenza vaccine for adults and children over 4 years of age. The manufacturer, Seqirus, plans to launch the new vaccine in time for the 2016-2017 flu season. Complete prescribing information for Flucelvax Quadrivalent is available at:

http://flu.seqirus.com/flucelvax/about-flucelvax.html

 

Expanded Invokamet Indication Approved

The FDA approved a new indication for Invokamet® (canagliflozin/metformin - Janssen) on May 24, 2016. It is now approved for use as a first-line treatment of adults with type 2 diabetes. Previously, it was approved for use in patients not adequately managed by treatment with canagliflozin, metformin or both. Canagliflozin, approved under the brand name of Invokana®, was the first glucose co-transporter 2 (SGLT2) inhibitor to receive FDA approval. SGLT2 inhibitors decrease glucose reabsorption in the kidneys causing more glucose to be excreted in urine. Metformin works primarily by reducing glucose production in the liver. Full prescribing information can be found at: www.Invokamet.com

 

Generic to Doryx 200mg Delayed-Release Tablets Launched

Mylan announced FDA approval and launch of its A-rated generic alternative to Mayne Pharma’s Doryx® (doxycycline hyclate delayed-release) 200mg tablets. The company was also granted 180 days of generic exclusivity preventing FDA from approving additional generics to this strength until March 2017. Doryx contains a tetracycline antibiotic that is used for a variety of conditions including acne, respiratory tract infections and sexually transmitted infections. According to IMS Health, annual U.S. sales of Doryx 200mg tablets are approximately $182 million.

 

MedWatch Updates

Ketoconazole

FDA is reminding clinicians not to prescribe ketoconazole tablets for common skin, fingernail or toe nail infections. Ketoconazole is an antifungal drug that should not be used as the first treatment for any fungal infection. It is intended to be reserved for severe fungal infections after other treatments have failed. Although FDA issued a warning and required labeling changes for oral ketoconazole in 2013, it still is being prescribed frequently for non-life-threatening infections, despite not being approved to treat them. Taking ketoconazole has been associated with damage to the adrenal glands, liver or both. At least one recent death also has been attributed to its use. Additionally, oral ketoconazole has major interactions with numerous other drugs, which include antibiotics in the erythromycin class, some antidepressants and antipsychotics, some cholesterol-lowering drugs known as statins and some medications for migraine headaches (triptans). Ketoconazole’s topical forms (cream, foam, gel and shampoo) are not included in FDA’s warning because they are not absorbed very extensively into the body. More information about the warning is at:

http://www.fda.gov/Drugs/DrugSafety/ucm500597.htm.

 

Methadone/Buprenorphine
In a Drug Safety Communication released on May 26, 2016, FDA restated cautions about the risk of neonatal opioid withdrawal syndrome (NOWS) among babies whose mothers used methadone or buprenorphine while pregnant. Both drugs are used, along with counseling, to treat dependence on opioids (also called opioid use disorder). Although they are recommended during pregnancy, both are opioids that may cause NOWS. As part of a broader Opioids Action Plan, FDA is reinforcing and clarifying labeling for opioid products. The Warnings and Precautions part of labels for methadone and buprenorphine products used to treat dependence will be required to indicate the risk of NOWS. FDA’s full notice is at:

http://www.fda.gov/Drugs/DrugSafety/ucm503630.htm.

 
27May
Express Scripts Clinical Matters News Flash

Express Scripts Clinical Matters News Flash

Afstyla Approved for Hemophilia A

 

On May 26, 2016, CSL Behring received approval from the U.S. Food and Drug Administration (FDA) for Afstyla® [antihemophilic factor (recombinant), single chain] to prevent bleeds as well as to manage bleeding episodes and to control bleeding associated with surgical or dental procedures. Dosing and dose frequency depend on the patient’s age and weight, and on whether the dose is for prevention or for treating an acute bleed. For routine prophylaxis, most patients will require an intravenous infusion two to three times per week. CSL Behring plans on launching Afstyla early this summer. It will be available through a limited network of specialty pharmacies that includes Accredo. Complete prescribing information is at: www.afstyla.com

 

  • Brand (Generic) Name: Afstyla® [antihemophilic factor (recombinant), single chain]
  • Manufacturer: CSL Behring
  • Date Approved: May 26, 2016
  • Indication: To treat and control bleeding episodes, to manage perioperative bleeding and to reduce the frequency of bleeding episodes in adults and children with hemophilia A.
  • Dosage Forms Available: Single-use vials containing 250 international units (IUs), 500IUs, 1,000IUs, 2,000IUs or 3,000IUs of powdered Afstyla.
  • Launch Date: CSL Behring plans on launching Afstyla early this summer.
  • Estimated Annual Cost: Pricing information is not yet available.
  • Specialty Status: Afstyla will be added to Express Scripts’ specialty drug list.
  • Hemophilia A is a rare, chronic, genetic bleeding disorder affecting approximately 16,000 adults and children in the United States. It is caused from insufficient clotting Factor VIII activity, which is a protein in the blood that controls bleeding. Patients with hemophilia A experience bleeding episodes that cause pain, irreversible joint damage and life-threatening hemorrhages.
  • Afstyla is a stabilized, single chain recombinant Factor VIII concentrate. Currently available products consist of both a heavy and a light chain which, under certain conditions, may dissociate leading to the formation of hemostatically inactive compounds.
  • Several recombinant Factor VIII products already are on the U.S. market. They include Advate (Baxalta), Helixate® FS (CSL Behring), Kogenate FS (Bayer), Kovaltry® (Bayer), Novoeight® (Novo Nordisk), Recombinate (Baxalta) and Xyntha® Solofuse® (Wyeth Biopharma). Two other long-acting products, Adynovate [antihemophilic Factor (Recombinant), PEGylated] and Eloctate [antihemophilic Factor (Recombinant), Fc Fusion Protein] are also available. Other Factor VIII products on the market are derived from human plasma and some also include von Willebrand factor.
 
23May
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Opdivo Approved for Hodgkin Lymphoma

On May 17, 2016, Bristol-Myers Squibb’s Opdivo® (nivolumab) gained approval from the U.S. Food and Drug Administration (FDA) for treating classical Hodgkin Lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation and post-transplantation Adcetris® (brentuximab vedotin – Seattle Genetics). The recommended dose is 3mg/kg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity. Opdivo injection is a human programmed death receptor-1 (PD-1) immune checkpoint inhibitor that was first approved by FDA in December 2014. It is also indicated to treat certain patients with advanced melanoma, non-small cell lung cancer (NSCLC) and renal cell carcinoma (RCC). Complete prescribing information for Opdivo can be found at:

http://packageinserts.bms.com/pi/pi_opdivo.pdf

 

Lenvima Approved for Kidney Cancer

Eisai announced on May 16, 2016, that the FDA has approved Lenvima® (lenvatinib) for treating patients with advanced renal cell carcinoma (aRCC) in combination with Afinitor® (everolimus – Novartis) following prior anti-angiogenic therapy. Lenvima is an oral multiple receptor tyrosine kinase inhibitor. It was first approved on February 13, 2015, for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC). The recommended dose for RCC is 18mg of Lenvima in combination with 5mg of Afinitor, once daily.  Full prescribing information is available at:

http://www.lenvima.com/pdfs/prescribing-information.pdf

 

MedWatch Update

Invokana/Invokamet
In a Drug Safety Communication dated May 18, 2016, FDA is warning that Janssen’s Invokana® (canagliflozin) and Invokamet® (canagliflozin/metformin) may be associated with an increased risk for foot, leg and toe amputations among patients using them. Although FDA does not have enough information to draw solid conclusions, mid-term results from an ongoing clinical study showed that more patients taking canagliflozin needed amputations than patients taking an inactive placebo. A second study did not find the same risk, however. Patients in the first trial have been treated for an average of four and one-half years; patients in the second one only have been treated for nine months, on average. Canagliflozin is a sodium-glucose cotransporter-2 (SGLT2) inhibitor that treats type 2 diabetes. FDA is not requesting label changes, at this time, but it will evaluate additional information from the trials. Patients are being warned to let their healthcare professionals know right away about any unusual infections, numbness, pain or sores involving their feet or legs. Prescribers are advised to monitor canagliflozin patients carefully for any signs of foot or leg problems. A separate alert was issued last year to caution about increased fracture risks and possible decreased bone mineral density from the use of canagliflozin. Along with other drugs in its class, it also may be linked with ketoacidosis (a potentially dangerous buildup of fatty acids in the blood) and urinary tract infections. The most recent FDA notice is at: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM501749.pdf

 

Updated DrugWatch Document Available

The Emerging Therapeutics department has updated DrugWatch, a document that highlights near-term pipeline drugs as well as potential new generic opportunities.  Click here for the updated DrugWatch document.

 
19May
Express Scripts Clinical Matters News Flash: Tecentriq Approved for Bladder Cancer

Express Scripts Clinical Matters News Flash: Tecentriq Approved for Bladder Cancer

On May 18, 2016, Genentech received approval from the U.S. Food and Drug Administration (FDA) for Tecentriq™ (atezolizumab) for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-based chemotherapy, or whose disease has worsened within 12 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). The recommended dose of Tecentriq is 1200mg as an intravenous infusion over 60 minutes every 3 weeks. Genentech plans on launching Tecentriq within 1-2 weeks. It will be available through a limited network of specialty pharmacies that includes Accredo. Full prescribing information can be found at: http://www.gene.com/download/pdf/tecentriq_prescribing.pdf

  • Brand (Generic) Name: Tecentriq™ (atezolizumab)
  • Manufacturer: Genentech
  • Date Approved: May 18, 2016
  • Indication: Treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-based chemotherapy, or whose disease has worsened within 12 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant).
  • Dosage Forms Available: 1200 mg/20 mL (60 mg/mL) solution in single-dose vials
  • Launch Date: Tecentriq is expected to be available by June 1, 2016.
  • Estimated Annual Cost: Pricing information is not yet available; however, it is expected to cost approximately $150,000 per year.
  • Specialty Status:Tecentriq will be added to Express Scripts’ specialty drug list.
  • Each year in the U.S., approximately 76,000 patients are diagnosed with bladder cancer. Urothelial carcinoma is the most common type of bladder cancer; it can also be found in the renal pelvis, ureter and urethra.
  • Tecentriq is a programmed death receptor-ligand 1 (PD-L1)-blocking antibody. It is an immunotherapy that helps the body’s immune system attack cancer cells.
  • Merck’s Keytruda® (pembrolizumab) and Bristol-Myers Squibb’s Opdivo® (nivolumab) are PD-1 blocking antibodies that are currently available on the market. Tecentriq is the first PD-1/PD-L1-blocking antibody to gain FDA approval for bladder cancer.
  • Tecentriq is a breakthrough therapy that was granted accelerated approval. It was approved almost 4 months ahead of its FDA action date of September 12, 2016.
  • FDA approval was based on a Phase II trial in patients with locally advanced or metastatic urothelial carcinoma. The study showed that Tecentriq shrank tumors in 27 percent of patients with mUC whose disease had medium and high levels of PD-L1 expression and worsened after initial treatment. Genentech is conducting a confirmatory Phase III trial to verify that the drug provides a clinical benefit in these patients.
  • Tecentriq is also a breakthrough therapy for the second-line treatment of patients with locally advanced or metastatic PD-L1+ non-small cell lung cancer. Approval for this expanded indication is expected by October 19, 2016.

 

 
16May
Express Scripts Clinial News and Notes

Express Scripts Clinial News and Notes

New Indication for Vibativ

Vibativ® (telavancin – Theravance Biopharma), an antibacterial drug, received a new indication from the U.S. Food and Drug Administration (FDA) on May 6, 2016. It originally was approved in 2009 to treat adult patients who have complicated skin and skin structure infections. In 2013, Vibativ was approved as an alternative to vancomycin for treating hospital-acquired or ventilator-associated pneumonia that is caused by Staphylococcus aureus (S. aureus) and that does not respond to other antibacterial drugs. It now has an additional indication for S. aureus bacteremia (S. aureus bacteria in the blood) among patients using it for one of its other indications. It is infused intravenously once a day with doses based on the patient’s body weight. A boxed warning on its label cautions that it should not be administered to patients who have decreased kidney function or to women who are pregnant. Its complete prescribing information is at:

http://www.vibativ.com/pdf/PrescribingInformation.pdf    

  

Labeling Expansion for Imbruvica

AbbVie and Janssen Biotech announced on May 9, 2016, that labeling for Imbruvica® (ibrutinib) can include additional information on results from two clinical trials. It already had FDA approvals for treating Mantle call lymphoma (MCL) and Waldenström’s macroglobulinemia. In March, it got a new indication as initial therapy for patients with chronic lymphocytic leukemia (CLL). This week, FDA approved another use – for treating small lymphocytic lymphoma (SLL). Additionally, in combination with bendamustine and rituximab, Imbruvica can be used, after one or more previous treatments, for patients whose CLL or SLL either came back or did not respond to previous therapy. Imbruvica, an oral Bruton’s tyrosine kinase inhibitor, is taken once a day at varying doses depending on the condition being treated. Full prescribing information for Imbruvica is at:

http://www.imbruvica.com/

 

MedWatch Update

Olanzapine

On May 10, 2016, FDA released a Drug Safety Communication to caution that using the drug olanzapine has been associated with a rare, but potentially very severe adverse reaction. Since it was first approved 20 years ago, a few patients using olanzapine have developed drug reaction with eosinophilia and systemic symptoms (DRESS). Usually beginning with a rash, fever and swelling in the face, lymph nodes or both, DRESS is characterized by increased numbers of eosinophils, which are white blood cells involved with regulating inflammation and immune function. DRESS can cause inflammation throughout the body. Among the olanzapine-related cases reported to FDA, one patient died; 22 others suffered serious heart, kidney, liver, lung or other internal organ damage. Dosing does not appear to be a major factor -- doses as low as 5mg caused DRESS for some of the affected patients. The average time to onset of symptoms was slightly less than three weeks after olanzapine was started. An antipsychotic medication that is used to treat bipolar disorder and schizophrenia, olanzapine is available as generics and it also is sold under the brand names Symbyax® (fluoxetine/olanzapine) and Zyprexa®. It has both oral and injectable forms. Presently, DRESS has no specific treatment other than discontinuation of the drug that is causing it. FDA now requires manufacturers to put a warning about the possibility of DRESS on the labels of all products that contain olanzapine. Patients are advised to get medical attention right away if they get a fever or rash while taking it. Doctors who suspect a patient might have DRESS should stop olanzapine immediately. FDA’s complete warning is at: http://www.fda.gov/Drugs/DrugSafety/ucm499441.htm.


Fluoroquinolone Antibiotics

In a Drug Safety Communication issued on May 12, 2016, FDA recommended limiting the use of antibacterial drugs in the fluoroquinolone (quinolone) class. FDA has determined that the risks of using quinolones for patients with uncomplicated bronchial, sinus and urinary tract infections are not justified when alternative therapies are available. Among their very serious possible side effects are anaphylaxis (a severe allergic reaction), intestinal infections, nerve damage, ruptured tendons, seizures and vision loss. Although reports of serious side effects are uncommon, the problems can cause permanent impairment or even death. The affected drugs are ciprofloxacin (Cipro®, generics), gemifloxacin (Factive®, generics), levofloxacin (Levaquin®, generics), moxifloxacin (Avelox®, generics), and ofloxacin. Labeling for all injected and oral quinolones now will include information on their possible risks. Ophthalmic (eye drop) and otic (ear drop) quinolones do not have the same chance of adverse effects, so they will not have a warning. FDA encourages patients using an oral or injected quinolone to read the Medication Guide that comes with each drug fill. They should immediately tell a healthcare provider about symptoms such as changes in heartbeats; numbness, pain or weakness in the arms or legs; rashes; sensitivity to light; and unusual responses to temperature or touch. Prescribers should make sure that patients are aware of what to report. When possible, a different drug should be prescribed to treat uncomplicated bacterial infections, especially for any patient who may have had previous problems with a quinolone. More information on the FDA Safety Communication may be found at: http://www.fda.gov/Drugs/DrugSafety/ucm500143.htm.

 
9May
Express Scripts - Clinical News and Notes

Express Scripts - Clinical News and Notes

Akovaz Approved to Treat Low Blood Pressure during Surgery. 
On April 29, 2016, Flamel Technologies received approval from the U.S. Food and Drug Administration (FDA) for Akovaz™ (ephedrine sulfate) for the treatment of clinically significant low blood pressure (hypotension) occurring in the setting of anesthesia (during surgery). Akovaz will be supplied as 50mg/mL single-use vials. The recommended dose of 5mg to 10mg should be given as an intravenous bolus after it is diluted. Akovaz contains ephedrine sulfate, an alpha- and beta-adrenergic agonist and a norephinephrine-releasing agent that increases blood pressure. While ephedrine sulfate has been used for many years, Akovaz is the first ephedrine sulfate product to gain FDA approval. Flamel Technologies plans on launching Akovaz in the third quarter of 2016. Full prescribing information can be found at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208289s000lbl.pdf  

Fycompa Oral Solution Approved
Eisai received FDA approval for Fycompa® (perampanel) CIII oral suspension. The new formulation is bioequivalent and interchangeable with the company’s Fycompa tablets, which were originally approved in October 2012. It is approved for the treatment of partial-onset seizures with or without secondarily generalized seizures, and primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older. Fycopma oral suspension is expected to be available in June 2016. Full prescribing information can be found at: www.fycompa.com  

MedWatch Updates
Brintellix Name Change
FDA has given Takeda Pharmaceuticals and Lundbeck Pharmaceuticals approval to change the brand name of their antidepressant, Brintellix® (vortioxetine). More than 50 prescribing and dispensing mix-ups involving Brintellix and an antiplatelet drug, Brilinta® (ticagrelor), have been reported since Brintellix was introduced in September 2013. To end confusion between the similar names, Brintellix is being re-named Trintellix. It will look the same – pink (5mg), yellow (10mg) or orange (20mg) tear-drop-shaped tablets; and directions for its use will not change. However, beginning in June, bottles of newly manufactured tablets will be labeled with the new brand name and a new National Drug Code (NDC) number assigned by FDA. For a few months, pharmacies may have bottles with both brand names in stock. AstraZeneca’s Brilinta will continue to be made as round, yellow tablets imprinted with “90” and a “T”. It is used to prevent heart attacks and strokes for patients who have acute coronary syndrome or who previously have had a heart attack. To assure that the drug is correct, FDA advises prescribers to include the generic name of the drug and the condition it is being used to treat on the prescription form or electronic transmission. Dispensing pharmacists and patients should check each prescription to be sure it is filled with the right drug. FDA’s Drug Safety Communication is at: http://www.fda.gov/Drugs/DrugSafety/ucm459579.htm.  

Aripiprazole
In a Drug Safety Communication issued on May 3, 2016, FDA is cautioning about uncontrollable behaviors that rarely may be associated with taking aripiprazole. Available as generics and with the brand names Abilify® and Aristada™ (aripiprazole lauroxil), aripiprazole is an antipsychotic medication used to treat a number of psychological conditions including autistic irritability, bipolar disorder, schizophrenia and Tourette’s syndrome. It also may be used with other drugs to treat depression. Feeling compelled to gamble already is listed as an uncommon side effect on its labeling. Now, FDA has identified other compulsions, such as overpowering cravings to eat, shop or engage in sexual activity, that also could result from taking aripiprazole. Most of the affected patients did not exhibit compulsive tendencies before starting treatment -- and decreasing or stopping aripiprazole eliminated the compulsions, as well. FDA will require manufacturers to include a warning about the possibility of these additional compulsions on the labeling and in the patient Medication Guides for all aripiprazole products. Prescribers, patients and caregivers should be alert for uncharacteristic compulsive behaviors. More detailed information on FDA’s action is at: http://www.fda.gov/Drugs/DrugSafety/ucm498662.htm   

Updated Biosimilars Issues Document Available
The Emerging Therapeutics department has updated the Biosimilars Issues Document to note the approval of Inflectra™ (infliximab-dyyb – Celltrion / Pfizer) and to describe FDA’s draft guidance on biosimilar labeling. Click here for the updated Biosimilars Issues document.

 
3May
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Bevespi Aerosphere Approved for COPD
AstraZeneca received approval on April 25, 2016, from the U.S. Food and Drug Administration (FDA) for Bevespi Aerosphere™ (glycopyrrolate/formoterol fumarate) inhalation aerosol. It is a combination of a long-acting muscarinic antagonist (LAMA) and a long-acting beta-2 agonist (LABA) for use as maintenance treatment for chronic obstructive pulmonary disease (COPD). The recommended dose is two oral inhalations (each containing 9mcg of glycopyrrolate and 4.8mcg of formoterol fumarate) in the morning and two in the evening. As with all LABA-containing drugs, labeling for Bevespi Aerosphere carries a boxed warning that it increases the chance of death among asthma patients, so it should not be used to treat asthma. It uses a proprietary new formulation technique, Co-Suspension™ Technology, that is intended to keep the drug mix consistent both within the inhaler device and in the lungs. When launched, it will compete with Anoro® Ellipta® (umeclidinium/vilanterol – GlaxoSmithKline), Stiolto™ Respimat® (tiotropium/olodaterol – Boehringer Ingelheim) and Utibron™ Neohaler® (indacaterol/glycopyrrolate – Novartis). Bevespi Aerosphere is expected to launch during the second half of 2016. Pricing information is not yet available. Its complete prescribing information is available at: www.Bevespi.com  

Abuse-Deterrent Xtampza ER Approved
The FDA approved Collegium Pharmaceutical’s Xtampza™ ER (oxycodone) extended-release capsules on April 26, 2016. Xtampza ER is a C-II opioid indicated for use as twice-daily treatment of chronic, severe pain that needs constant opioid therapy and that has not been controlled by other treatment. Xtampza ER will launch around the middle of the year as 10mg, 15mg, 20mg, 30mg and 40mg capsules. Using a new method, the opioid is mixed with wax and fatty acids to form microspheres that each contain active drug. The wax keeps the opioid from being dissolved and injected; it also prevents rapid release of the oxycodone if the capsules are mashed. Both the potential for abuse and the risk of overdosing are reduced significantly. Additionally, capsules can be opened to sprinkle on soft foods and then given to patients who cannot swallow whole capsules. Xtampza ER and all other opioids approved in the U.S. still must have a boxed warning about their potential for abuse and misuse. Their labeling also cautions about accidentally taking them, serious breathing problems that may occur with their use and addiction among babies whose mothers use opioids while pregnant. Prescribing information for Xtampza is posted at: http://www.collegiumpharma.com/uploads/downloads/Xtampza-ER-Full-Prescribing-Information.pdf.   

Oral Solution Approved for Orfadin  
On April 22, 2016, the FDA approved a 4mg/mL oral solution formulation of Orfadin® (nitisinone), which is made by Swedish Orphan Biovitrum AB (Sobi™). Used along with diet limitations, it treats a very rare genetic disease known as hereditary tyrosinaemia type-1 (HT-1). Individuals who have HT-1 cannot utilize tyrosine, an amino acid, so impurities accumulate in their blood. Serious, and even fatal, kidney, liver and nerve damage can result. HT-1 affects only a few hundred patients – mainly children. Orfadin blocks an enzyme to prevent the buildup of tyrosine by-products. Because Orfadin doses are determined by the patient’s weight, doses change frequently. A liquid form of the drug makes both dosing and dose adjustments easier. Previously, Orfadin was available only in 2mg, 5mg and 10mg capsules that had to be mixed with water for children who could not swallow them. Orfadin Oral Suspension, 4mg/mL will be released in August 2016. Prescribing information is at: http://www.raretx.com/insert/Orfadin%20Package%20Insert.pdf  

Expanded ProAir RespiClick Indication Approved
On April 28, 2016, the FDA approved an expanded indication for Teva’s ProAir® RespiClick (albuterol sulfate) inhalation powder for the treatment and prevention of bronchospasms in children 4 to 11 years old with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasms. ProAir RespiClick was approved in March 2015 with the same indications for patients at least 12 years of age. Full prescribing information can be found at: www.myproair.com  

Nuplazid Approved for Parkinson’s Disease Psychosis
On April 29, 2016, the FDA approved Acadia Pharmaceuticals’ Nuplazid™ (pimavanserin) for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. The recommended dose is 34mg (two 17mg tablets) once daily. Acadia plans on launching Nuplazid by the end of May. It will be available through a limited network of specialty pharmacies that includes Accredo. Full prescribing information can be found at: https://www.nuplazid.com/.  

Generic Crestor Launched
Allergan has announced the launch of the first AB-rated generic to AstraZeneca’s Crestor® (rosuvastatin calcium) in the United States. Under terms of a settlement, Allergan was allowed to introduce its generic to the U.S. market 67 days before Crestor’s patent expires on Jul. 8, 2016. Other generics are expected to launch after this patent expires in July.  

MedWatch Updates
Fluconazole
On April 26, 2016, FDA posted a Safety Alert about the use of oral fluconazole by women who are pregnant. Fluconazole is an antifungal drug frequently taken on one day, as a 150mg tablet, to treat vaginal yeast infections. In higher doses and for longer periods, it also prevents and treats some types of meningitis, pneumonia and other systemic infections that are caused by several different fungal organisms. Labeling for oral fluconazole, available as generics and under the Pfizer brand name, Diflucan®, already has a warning that it should not be used long-term or in high doses for pregnant women because it can cause birth defects such as weakened bones, cleft palate and heart disease. The low, single-tablet dose is thought less likely to cause problems with fetal development. A recent study, however, found a possible increase in the risk of miscarriage when only one or two 150mg doses were used. While FDA is evaluating the study and other relevant information, it advises that topical rather than oral antifungal products be used to treat vaginal yeast infections during pregnancy. FDA’s warning is at:  http://www.fda.gov/Drugs/DrugSafety/ucm497482.htm.    

Updated DrugWatch Document Available
The Emerging Therapeutics department has updated DrugWatch, a document that highlights near-term pipeline drugs as well as potential new generic opportunities. Click here for the DrugWatch document
 
 
26Apr
Cabometyx Approved for Kidney Cancer

Cabometyx Approved for Kidney Cancer

On April 25, 2016, Exelixis received approval from the U.S. Food and Drug Administration (FDA) for Cabometyx™ (cabozantinib) for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. The recommended dose is 60mg once daily. Exelixis plans on launching Cabometyx within two weeks. It will be available through a limited network of specialty pharmacies that includes Accredo. Full prescribing information can be found at: https://hcp.cabometyx.com/downloads/CABOMETYXUSPI.pdf  
  • Brand (Generic) Name: Cabometyx™ (cabozantinib)
  • Manufacturer: Exelixis, Inc.
  • Date Approved: April 25, 2016
  • Indication: Treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy
  • Dosage Forms Available: 20mg, 40mg and 60mg tablets
  • Launch Date: By May 9, 2016
  • Estimated Annual Cost: Cabometyx is expected to cost approximately $165,000 per year.
  • Specialty Status: Cabometyx will be added to Express Scripts’ specialty drug list.
  • According to the American Cancer Society, approximately 63,000 new cases of kidney cancer will be diagnosed among American adults in 2016. About 90% will be RCC and an estimated 17,000 RCC patients will need secondary treatment after an anti-angiogenic drug. Nearly all RCC patients are older than 45 years, with men around twice as likely to have RCC as women.
  • Cabometyx interferes with the activity of several receptor tyrosine kinases, proteins which promote the growth and spread of tumors.
  • In clinical trials, overall survival for RCC patients taking Cabometyx was about five months longer than for patients taking the comparator drug, Afinitor® (everolimus – Novartis). Progression-free survival was nearly twice as long (7.4 months vs. 3.8 months). Objective response rate, a measure of tumor size decrease, was 21% for Cabometyx and 5% for Afinitor.
With the brand name Cometriq®, cabozantinib initially was FDA approved in November 2012, for treating metastatic medullary thyroid cancer (MTC). Although both are oral medications, Cabometyx tablets and Cometriq capsules are not interchangeable. 
 
25Apr
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

MedWatch Update

FDA Approvals Withdrawn for Certain Drugs and Indications

Through a notice published in the Federal Register on April 18, 2016, FDA formally revoked its approval for two drugs that combined a statin with another cholesterol-lowering drug. Stating that reducing triglycerides or increasing high-density lipoprotein cholesterol (HDL-C) has not been proven to decrease cardiovascular risk, FDA rescinded approvals for Advicor® (lovastatin/ niacin extended release/) and Simcor® (simvastatin/niacin extended release). Neither drug has been distributed since the end of 2015; and their manufacturer, AbbVie, voluntarily stopped production of both earlier in 2015. More information on the FDA’s action is available at: https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-08887.pdf    

In a related move, FDA also withdrew approvals of indications for use with a statin from AbbVie’s Niaspan® (niacin) extended-release tablets, Trilipix® (fenofibric acid) delayed-release capsules and their respective generics. AbbVie had revised its prescribing information for both Niaspan and Trilipix in April 2015 to eliminate the rescinded indications. It notified prescribers, pharmacies and patients of the revision at that time. Many generic manufacturers have changed their prescribing information, as well. Both drugs have multiple other indications that have not been affected and both will continue to be marketed in the U.S. Information about the changes is at: https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-08887.pdf.
 
9May

AFSPA Image Usage

As a reminder, AFSPA routinely takes photos at its events. Members and guests should notify the photographer if they want to restrict the use of their names and/or images. Without notification, you are permitting AFSPA to publish your image(s) on its websites, newsletters, marketing materials, etc. 
 
1May
From the CEO

From the CEO

Greetings and welcome to May 2016! The American Foreign Service Protective Association (AFSPA) is devoted to meeting the needs of the Foreign Service community. We strive “to provide unparalleled service that our unique worldwide membership requires.” This is not just our mission statement, but it is how we approach the work we do every day at AFSPA. Thank you for trusting us with your lives and your health. We do not take it for granted.

To begin, the annual Public Service Recognition Week is happening May 1-7, 2016. This is a time in which government service at the Federal and other levels is recognized. The key messages for the week are: “government workers are doing important work that positively affects all of us every day; the government needs people like you to address the incredible challenges our nation is facing; public servants deserve thanks for working diligently on our behalf; and government service is public service.” I agree with these statements; I witness your commitment to our country throughout my travels and here at home.  Thank you for your solid service, especially during these trying times. 

As you approach the age of 65, many questions arise about your health benefits and the role that Medicare plays. It is important to us to make the transition easier for you, which is why we developed a new publication: Medicare and the Foreign Service Benefit Plan: Putting it Together. This simple six-panel brochure provides detailed information on how to sign up for Medicare and how Medicare works with FSBP. It outlines the four parts of Medicare and even includes helpful links at the end. Click here to view the entire booklet. In addition, you can view my video presentation about Medicare. Click here to view the video. I am sure you will find the content useful and valuable.

Lastly, for the first time the Senior Living Foundation (SLF) is one of the sponsors of this year’s Foreign Affairs Day, happening on Friday, May 6, 2016. The event serves as a homecoming for retirees from the State Department and provides them with an opportunity to engage with active officers and learn about current developments at State. SLF has participated in Foreign Affairs Day for many years. Please visit the SLF website at www.slfoundation.org for event pictures and more information about the Foundation.

Please enjoy your Memorial Day holiday, as we remember those who have died serving in our country’s armed forces. We honor those who have given their lives for our freedom. As always, thank you for your trust and for giving AFSPA the opportunity to serve you.

To Your Health,
Paula S. Jakub, RHU
CEO, AFSPA
Executive Director, Senior Living Foundation

 
27Apr

Express Scripts Update - Website and Systems Operating Normally

As of late yesterday evening, all Express Scripts systems - including the website and the mobile site - are operating normally.

I apologize for any inconvenience you may have experienced during this outage. Thank you for your patience.
 
26Apr
Update on Express Scripts Systems

Update on Express Scripts Systems

At 2 pm EDT, we received confirmation that applications used by Express Scripts' Patient Care Advocates to assist members when they call are back up and running.

The team at Express Scripts is still working to bring the member website back to full functionality. We hope to have more information soon.

Thank you for your patience.
 
26Apr
Express Scripts Website and Systems Temporarily Down

Express Scripts Website and Systems Temporarily Down

This morning, we received notification from our partners at Express Scripts that they are experiencing technical issues. The issues are affecting the Express Scripts website as well as the systems used by Patient Care Advocates answering member telephone calls. Express Scripts is working to correct the problems as quickly as possible.

We ask your patience while the fixes are underway. Check back here for updates.
 
14Apr

Venclexta Approved for Lymphocytic Leukemia

This is an Express Scripts Clinical Flash, 12 April 2016.pdf
 
14Apr

AFSPA Closing 3:00P.M. EDT – 4/14/16


AFSPA will be closing at 3:00P.M. EDT on Thursday, April 14, 2016. We apologize for the inconvenience. We will resume normal business hours on Friday, April 15, at 8:30 A.M. EDT.
You may submit claims via our secure Member Portal at any time, by going to: https://secure.myafspa.org .

We look forward to serving you on Friday, April 15, 2016.

Thank you.
 
4Apr

Clinical Matters News & Notes Release

This is an Express Scripts Clinical Matters News & Notes Release, 28 March 2016.pdf
 
2Apr

Member Portal Scheduled Maintenance

Please be advised that on April 3, 2016 Member Portal ( https://secure.myafspa.org/) may be unavailable from 
7:00 pm-12:00 am EDT as it will be undergoing maintenance. 

We apologize for the inconvenience


 
1Apr
From the CEO

From the CEO

Greetings and Welcome to Spring 2016! What a privilege and a responsibility it is to play a role in serving almost 60,000 FSBP members and the thousands of others who are members of our other programs and the Association every day. I am grateful for the trust that each person places in our health plan and other programs.

April is designated as National Minority Health Month.
 This annual event sets aside time to raise awareness about the health disparities that affect racial and ethnic minorities. This year's theme is Prevention is Power: Taking Action for Health Equity. It emphasizes the role of prevention in reducing health disparities. FSBP offers many programs aimed specifically at preventing serious medical conditions. Healthy Actions like Digital Coaching address unique health challenges such as cholesterol management, stress management, and even weight control. FSBP recognizes that everyone should have the chance to live a healthy life, regardless of who they are and where they live.
Click here to learn more about National Minority Health Month from the U.S. Department of Health and Human Services.


World Immunization Week, a global public health initiative to raise awareness and increase rates of immunization against vaccine-preventable diseases around the world,  takes place each year during the last week of April. Immunizations can protect against 25 different infectious agents or diseases, from infancy to old age, including measles, pertussis, polio, and tetanus. Under FSBP’s Preventive care benefits, the plan covers adult routine immunizations (including administration) endorsed by the Centers for Disease Control and Prevention (CDC) per their Recommended Adult Immunization Schedule by Vaccine and Age Group. For children, FSBP covers childhood immunizations recommended by the American Academy of Pediatrics for members under age 22. For both adults and children, FSBP covers travel immunizations recommended by the CDC. This is a great time to make sure you and your family members are up-to-date on all immunizations.

We want to thank you for sending feedback about AFSPA’s new website. Many of you like the brighter colors and the fresh pictures. However, we realize that some members encountered issues when searching for specific information. We are working to reorganize and streamline the content. In addition, we are adding a “Help” button option to provide members and visitors with a guided tour through the website and its features. Our goal is to make the website as user friendly as possible. Enhancing the AFSPA site is an ongoing initiative. Please continue to offer feedback. We want to make the overall experience better for you.

Over the last few years, AFSPA has evolved and expanded. We have an outstanding team in place, including a strong, experienced leadership team. AFSPA has built a solid foundation for growth and is well positioned to continue growing. We recognize our current members have been affected and may have experienced longer wait times and longer claims processing times as we go through our “growing pains.” We apologize for any inconveniences and thank you for your patience. Please trust that we are taking steps to improve our services. AFSPA has hired and trained additional staff in recent months. We will continue to examine how we can better provide the unparalleled service you expect.

By the way, have you joined our Facebook page yet? We are building a strong community of AFSPA members. You should get in on the conversation too.

As always, thank you for your trust and for giving AFSPA the opportunity to serve you.

To Your Health,
Paula S. Jakub, RHU
CEO, AFSPA
Executive Director, Senior Living Foundation
 
31Mar

AFSPA Closing 4:00 P.M. EDT - 3/31/16

Due to unforeseen circumstances, AFSPA will close at 4:00P.M. EDT on Thursday, March 31, 2016. We apologize for the inconvenience. We will resume normal business hours on Friday, April 1, at 8:30 A.M. EDT. You may submit claims via our secure Member Portal at any time, by going to: https://secure.myafspa.org . We look forward to serving you on Friday, April 1, 2016. Thank you for your patience and cooperation.
 
30Mar

Families of U.S. Personnel Will Be Evacuated from Turkey

The Foreign Service Benefit Plan (FSBP) has been advised that the Department of State and the Department of Defense will evacuate almost all family members from their facilities in Turkey.  They have cited security concerns as the campaign against the Islamic State continues.   

As with other relocations of FSBP members, we request members to advise us of temporary and/or permanent relocations. We want to continue uninterrupted delivery of your medications and handle your claims appropriately.  

We ask that you contact Express Script’s (ESI, the Plan’s Pharmacy Benefit Manager) Member Services at 1 800 497-4641 and keep them apprised of your current mailing address to assure proper delivery of medication.  

In addition, you may contact the Plan directly to update your information:
  • Through our secure Internet connection at: https://secure.myafspa.org
  • By phone at 1 202 833-4910 and asking to speak to our Member Quality Services Department; or
  • By fax at 1 202 833-4918. 
The FSBP continues to monitor situations that require keeping lines of communication open with those of you who could be affected by the disruption of medicine delivery and/or claim information.
 
29Mar

OPM Selects New FSAFEDS Contractor

The Office of Personnel Management (OPM) has selected WageWorks, Inc. as the new Federal Flexible Spending Account Program (FSAFEDS) contractor.   

www.wageworks.com/about/news/press-releases/march-2016/united-states-office-of-personnel-management-chooses-wageworks-to-administer-flexible-spending-account-program  

The effective day of the contract was March 1, 2016.  Transition activities are underway and will continue until WageWorks, Inc. assumes full administration of FSAFEDS in the Fall. This change will have no impact on enrollee balances, contributions or eligible expenses.  

More information will be provided as the transition progresses.  

Please send any questions and/or comments to [email protected]

 
24Mar

Clinical Matters News & Notes Release

This is an Express Scripts Clinical Matters News & Notes Release, 21 March 2016.pdf
 
24Mar

Kovaltry Approved for Hemophilia A

This is an Express Scripts Clinical Flash,17 March 2016.pdf
 
24Mar

Clinical Matters News & Notes Release

This is an Express Scripts Clinical Matters News & Notes Release,14 March 2016.pdf
 
15Mar

AFSPA Closed Wednesday, March 16, 2016!

Due to an unprecedented regional emergency, the Washington Metropolitan Area Transit Authority (WMATA) is suspending transportation services for the Washington DC area on Wednesday, March 16, 2016. Please see the official message from WMATA below:

“The Metrorail system will close at its normal time tonight (midnight) and remain closed until 5 a.m. Thursday. All six Metrorail lines and all 91 stations will be closed on Wednesday.” 

This incident led AFSPA to make the decision to close the office during this time period.

Our partners at Aetna will be accepting all member calls during AFSPA’s regular business hours of 8:30A.M. to 4:30P.M. (EST). Please anticipate longer wait times due to this unforeseen emergency.

AFSPA is expected to reopen on Thursday, March 17, 2016 at 8:30A.M. (EST). Please check our website for the most up-to-date information.

Thank you for your patience. We look forward to serving you on Thursday, March 17, 2016.
 
9Mar

Idelvion Approved for Hemophilia B

This is an Express Scripts Clinical Flash, 8 March 2016.pdf
 
9Mar

Clinical Matters News & Notes Release

This is an Express Scripts Clinical Matters News & Notes Release, 7 March 2016.pdf
 
7Mar
AFSPA is now offering a new CIGNA Global Disability Plan!

AFSPA is now offering a new CIGNA Global Disability Plan!

We now offer a Disability Income Protection Plan that does not require a health application to enroll. This is your opportunity to fill in your income protection gap. Cigna Global Health Benefits offers a 2-year & a 5-year benefit option, covers maternity that begins after the effective date, covers war and terrorism, and covers you stateside and overseas. To learn more, call 202-833-4910 or visit www.afspa.org/disability. Sign up today!
 
1Mar
FROM THE CEO

FROM THE CEO

Welcome to March 2016! The season of Spring means new beginnings. A new emphasis for Spring 2016 is the establishment of a Facebook page for the American Foreign Service Protective Association. We wanted to utilize social media to tell more stories, to offer more resources, and to continue strengthening the AFSPA community. With Facebook's one billion worldwide members, it made sense to pursue this popular communication platform. Our members will have access to the information no matter where they are located. Please click here to join the AFSPA Facebook page. You will receive regular updates and learn how we strive to offer you the unparalleled service you expect from us.

As mentioned last month, AFSPA now has a New Disability Income Protection Plan, underwritten by CIGNA. AFSPA began offering this additional Disability Plan in February 2016. Enrollment does not require a health application. The plan covers war, terrorism, and maternity (whose inception begins after the effective date). For more information, call AFSPA at 202-833-4910 or visit www.afspa.org/disability. Your enrollment is guaranteed so consider joining now. AFSPA continues to offer the existing long term disability plan from Lloyds of London, which offers a unique Lump Sum Payment feature. It is important for members to have choices that best suits their needs.


Lastly, March is National Nutrition Month. It focuses attention on the importance of making informed food choices and developing sound eating and physical activity habits. This would be a great time to explore the Mediterranean Wellness Program offered to all FSBP members. The eight week interactive online program gives you access to a registered dietician. It also offers a support manual with information to help manage your weight. If you didn’t know, the Mediterranean Wellness Program counts as a Healthy Action for those completing the Simple Steps to Living Well Together Program. So start your path to better eating and earning a $50 incentive credit today. Please refer to the 2016 FSBP Brochure to explore the many other programs that can help members with nutrition goals, including our Weight Management Program, Health Coaching Program and TherapEase Cuisine, just to name a few.
 

We hope your family has a happy and healthy Spring. As always, thank you for your trust and for giving AFSPA the opportunity to serve you.

To Your Health,
Paula S. Jakub, RHU
CEO, AFSPA
Executive Director, Senior Living Foundation



 
1Mar

Clinical Matters News & Notes Release

This is an Express Scripts Clinical Matters News & Notes Release, 29 February 2016.pdf
 
1Mar

Clinical Matters News & Notes Release

This is an Express Scripts Clinical Matters News & Notes Release, 17 February 2016.pdf
 
1Mar

Generic Glumetza Launched

This is an Express Scripts Clinical Flash, 2 February 2016.pdf
 
22Feb
Did you forget to enroll in a Dental Plan?

Did you forget to enroll in a Dental Plan?

Learn more about AFSPA’s Dental Plans! AFSPA offers four different dental plans to meet the needs of our worldwide membership.  This includes a true international plan that covers any dentist worldwide. AFSPA’s dental plans have no open enrollment period and cover unmarried dependents up to age 26. There are over 600,000 in-network providers throughout the United States. Call or e-mail us at (202) 833-4910 or [email protected] to enroll today!
 
12Feb

Generic Gleevec Launched

This is an Express Scripts Clinical Flash, 1 February 2016.pdf
 
12Feb

Zepatier Approved for Hepatitis C

This is an Express Scripts Clinical Flash, 29 January 2016.pdf
 
4Feb

Aetna update on Zika Virus

Outbreaks of the Zika virus infection in Central and South America have authorities investigating a potential link between the virus in pregnant women and microcephaly – abnormal smallness of the head – and other poor outcomes in babies. - For more information click here.
 
2Feb
FROM THE CEO

FROM THE CEO

Greetings from the nation’s capital! We experienced this winter’s first major snow storm last month. We followed the guidance of the Office of Personnel Management and closed our office for several days while the region cleaned up and recovered from the devastating blizzard. I apologize for any interruptions in customer service and thank you for your patience. You can find the latest information on closures, unexpected delays, or early dismissals affecting our office on the newsfeed on www.afspa.org.


The Protective Association prides itself for checking the current insurance marketplace to determine if we are offering the programs that address our members’ current and future needs. We are happy to announce a New Disability Income Protection Plan, underwritten by CIGNA. AFSPA is offering this additional Disability Plan starting February 2016. Enrollment does not require a health application. Plus the plan covers war, terrorism, and pregnancy (when inception begins after the effective date). There are options for a 2-year and a 5-year benefit period. For more information, call AFSPA at 202-833-4910 or visit our website www.afspa.org, under Ancillary Insurance Programs. Your enrollment is guaranteed. We will continue to offer the popular existing long term disability plan, which offers a unique Lump Sum Payment feature.  We feel it is important for members to have choices that best suits their individual needs.


I am also pleased to announce the success of the new the Foreign Service Benefit Plan’s (FSBP) Simple Steps to Living Well Together Program. Over 700 members have completed Step One: the Health Risk Assessment (HRA) during the month of January. This also means over 700 members have earned a $100 gift card. The HRA is like an interview you take online or over the phone. You share information about your health habits and history. When completed, you receive a personalized health summary that can help you understand your individual health needs. This information can assist you in setting meaningful goals for yourself.  You can choose from the many programs offered by FSBP that can help you meet those goals. The $100 gift card reward arrives a few weeks after you submit your HRA and select your preferred reward. It is that simple!  


Lastly, February is American Heart Month. According to the American Heart Association, cardiovascular disease — including heart disease, stroke, and high blood pressure — is responsible for one out of every three deaths. It is the No. 1 killer of American women and men, and it is a leading cause of serious illness and disability. If you have high blood pressure, I encourage you to take steps to control it. Make sure to complete your routine physical examination, which FSBP covers at 100% when you visit an in-network provider or a provider outside the U.S. Monitoring your blood pressure is the best form of prevention. Click here to learn how the Centers for Disease Control and Prevention (CDC) suggests you take better care of your heart.


We hope your family stays safe, warm, and healthy this winter. As always, thank you for your trust and for giving AFSPA the opportunity to serve you.


To Your Health,
Paula S. Jakub
 
1Feb

WHO Declares International Emergency Regarding Zika Virus

The World Health Organization has declared an international emergency over the spread of the Zika virus, which is linked to birth defects in the Americas.  For more information and guidance, please click here.
 
1Feb

IRS Forms 1095-B and 1095-C Information

Beginning in 2016, Foreign Service Benefit Plan (FSBP) enrollees will receive the IRS Form 1095-B from the American Foreign Service Protective Association, underwriter for the FSBP, showing that you were covered under the FSBP. If you have questions about the information on IRS Form 1095-B, or about lost or incorrect forms, you should contact us at (202) 833-4910 or at: [email protected]. Please do not contact OPM, your employing agency, or your retirement office about IRS Form 1095-B. OPM and the agencies will not be able to answer questions about the information on IRS Form 1095-B. It is our responsibility to make corrections to and answer questions about IRS Form 1095-B.

Federal employees also will receive the IRS Form 1095-C regarding their offer of health coverage from their employing agency. You should direct your inquiries related to IRS 1095-C Form to your employing agency. Annuitants who were employed a portion of the year will receive an IRS Form 1095-C also from your former employer. Otherwise, annuitants will not receive this form.

Click here for "Health Care Coverage Forms for Federal Employees Health Benefits - Fast Facts".

Click here for "Health Care Coverage Forms for Annuitants - Fast Facts".
 
25Jan
AFSPA Closed Today

AFSPA Closed Today

Following an historic blizzard, much of the Washington metro region remains buried in snow. AFSPA is following the direction of the Federal government and will remain closed on Monday, January 25.

We will continue to follow the government's lead and assess our ability to open. My colleagues and I look forward to serving you when we re-open. In the meantime, I encourage you to explore the website for answers to your questions and information about our programs.
 
22Jan

Clinical Matters News & Notes Release

This is an Express Scripts Clinical Matters News & Notes Release,18 January 2016.pdf
 
22Jan
AFSPA Closing at 10:45 today

AFSPA Closing at 10:45 today

The most recent forecasts for the Washington, DC metro region indicate that snow will begin to fall in the early afternoon. To allow our staff time to get home safely, we will close our office and shut down the phones at 10:45 am today. We will monitor conditions and follow the Federal government's operating decision next week.

For providers trying to reach the Foreign Service Benefit Plan, our provider call center is closed today due to inclement weather that has already reached that location.


All of us on staff at AFSPA wish all of our members - particularly those in the path of this storm - a safe weekend.

- Kyle Longton
 
21Jan
Planned Early Closing

Planned Early Closing

The Washington, DC metro area is expecting a major weather event on Friday and Saturday, January 22 and 23. Meteorologists are predicting blizzard conditions resulting in up to two feet of snow.

The Federal government will decide on its operating status on Friday morning. If the Federal government closes for the day, AFSPA will also close. If the Federal government is open, AFSPA will make every effort to open on time. We will close our office no later than 12:30pm. I will announce any changes via our website and answering service. The early closure will allow AFSPA staff members to travel home safely before the worst of the storm arrives.

Thank you for your understanding. I wish the best to all AFSPA members around the world who are facing inclement weather.

- Kyle Longton, COO


 
19Jan

Military Treatment Facilities (MTFs)

Many Military Treatment Facilities (MTFs) are no longer doing third party billing (submitting the claims to insurance providers and accepting payment from them).  Instead, they will provide you an invoice with claim information and require you to pay the bill.  In order to process a claim, the Plan needs key pieces of information.  It is important that you send us all of the pages of the invoice.  For example, we are finding that the diagnoses do not appear on the invoice until the second or third page of the invoice.  The Plan will pay benefits for covered services to the member and not the MTF, provided we have sufficient information to process the claim.  Paying the MTF will be the member’s responsibility.  In addition, some MTFs are billing for services that were rendered beyond the Plan’s timely filing limit.  If that happens, please submit your claim as soon as you receive it so that we can review for processing.
 
1Jan
From the CEO

From the CEO

Happy New Year and Welcome to 2016! At this time of year, we usually make resolutions related to improving our health. This could include quitting smoking, losing weight, or developing a regular exercise routine. Let the Foreign Service Benefit Plan (FSBP) assist you with your goals. We have redesigned our wellness program, Simple Steps to Living Well Together, to help you identify your health risks and achieve your health goals. The best part is…you earn rewards along the way. Click here to learn about the complete program and the three simple steps to better health.

As you know, Open Season for the Federal Employees Health Benefits program officially ended December 14, 2015.  We want to welcome all our new FSBP members. It is an honor to be your chosen health plan. Please become familiar with all the great benefits and programs that now are available to you.. And after a long holiday season, a good way to begin is to  utilize your massage therapy benefits to relieve the additional stress. As a reminder, we cover 40 visits per year, up to $60 per visit. That is over three massages each month. January is a great time to get started.

Did you forget to sign up for dental insurance during the Federal Open Season? AFSPA offers dental plans that you can join at any time. Our Cigna HMO plan has no claim forms, no calendar year deductible  or maximums and no waiting periods . Our Cigna PPO plan also does not have a calendar year deductible and provides access to over 200,000 in-network providers nationwide.  You also have the flexibility of using an out-of-network dentist.  Both these dental plans cover your unmarried dependents up to age 26. This is a great time to explore dental insurance through AFSPA. Click here to choose one of our four popular dental plans.  

In 2016, AFSPA will continue to make improvements as well. Please look for more changes especially as AFSPA explores social media. We are striving to build a community and give you a forum to have open conversations. The first venture will be the launching of our Facebook page in early 2016. Look for more details coming soon.

Once again, I wish you a prosperous New Year. As always, thank you for your trust and for giving us the opportunity to serve you.

To Your Health,

Paula S. Jakub
 
30Dec

Happy New Year!

AFSPA will close at 4:30 pm on Thursday, December 31, and will be closed all day on Friday, January 1. We will resume our normal business hours at 8:30 am on Monday, January 4.

We wish all of our members a happy and healthy New Year.
 
29Dec

Zurampic Approved for Gout

This is an Express Scripts Clinical Flash, 23 December 2015.pdf
 
28Dec

Bendeka Approved for Chronic lymphocytic leukemia (CLL) and Indolent B-cell non-Hodgkin lymphoma

This is an Express Scripts Clinical Flash, 9 December 2015.pdf
 
23Dec

Vonvendi Approved for von Willebrand Disease

This is an Express Scripts Clinical Flash, 10 December 2015.pdf
 
23Dec

Kanuma Approved for Lysosomal Acid Lipase Deficiency

This is an Express Scripts Clinical Flash, 8 December 2015.pdf
 
23Dec

AFSPA is closing early for Christmas

Please be advised AFSPA will be closing early for Christmas on Thursday, December 24th at 12:00 P.M. Our offices will remain closed on Friday, December 25th, 2015. We will resume regular business hours on Monday December 28th, 2015.

Happy Holidays!


 
18Dec
AFSPA is closing early today

AFSPA is closing early today

Please be advised that our offices will be closing at 11:15 A.M. today Friday, December 18th, 2015.

We will resume regular business hours on Monday, December 21st, 2015.


Thank you.
 
17Dec

A guide to the Aexcel specialist performance designation

A guide to the Aexcel specialist performance designation

Aexcel is our designation for high-performing specialty doctors and doctor groups in 12 medical specialty areas:
  • Cardiology
  • Obstetrics and gynecology
  • Cardiothoracic surgery
  • Orthopedics
  • Gastroenterology
  • Otolaryngology/ENT
  • General surgery
  • Plastic surgery
  • Neurology
  • Urology
  • Neurosurgery
  • Vascular surgery
        
    Doctors with the Aexcel specialist designation have met added standards for volume, clinical performance and efficiency.  We evaluate these doctors using specific standards and based on the results, we give them the Aexcel specialty designation.  

    How do you find a doctor with the Aexcel specialty designation?  Visit http://fsbp.coventryhealthcare.com, Select “Locate a Provider” and enter your initial search criteria (e.g. zip, city/county, state, name or specialty).  After preliminary results are returned, under “Narrow Your Results” in left margin select “Show Only Aexcel Providers”.  You also can scroll through initial results for blue star * next to provider’s name.

    Evaluation Standards  

    First, we evaluate volume.  We identify doctors who have managed at least 20 episodes of care for Aetna members over the past 3 years.  An episode of care is defined as all services provided to a patient with a medical problem within a specific period of time across a continuum of care in an integrated system. For example, a hip implant, months of chemotherapy, treatment for a chronic eye infection or foot surgery.  

    Second, we evaluate the doctors’ clinical performance.  We use five categories of measures.  Doctors must meet standards in one of five categories: use of technology; Alignment with Institutes of Quality® (IOQ); Certification by an external entity such as the National Committee for Quality Assurance (NCQA); Performance based improvement model; or Claim based measures.  

    The third and final factor we look at is efficiency.   To do so, we examine what these doctors charge Aetna members for services and how many and what types of services they perform.  We consider all costs of care including inpatient, outpatient, diagnostic, laboratory and pharmacy claims.  There are some doctors who care for more patients with chronic or complex conditions in a given time period.  To make sure we are comparing apples to apples, we use risk-adjustment factors like age, gender and disease risk.  This way, we are able to evaluate all doctors on a level playing field by comparing their services for patients with similar conditions.    

    What if a specialist does not have a blue star:  This does not mean the doctor does not provide quality services.  It could be that we do not have enough information available to evaluate a particular doctor or the doctor’s specialty is not one of the 12 specialty categories. 

    The blue star identifies doctors who have earned the Aexcel specialty designation. These are doctors you might want to consider for specialty care.  However, Aexcel information is only a guide.  There are many ways to evaluate doctor practices.  You should talk with your primary care doctor and the specialist you are considering before making a decision.   Please note that ratings have a chance for error.  An Aexcel designation is not a guarantee of service quality or treatment outcome. Therefore, they should not be the only reason for choosing a specialty doctor.
 
16Dec

Clinical Matters News & Notes Release

This is an Express Scripts Clinical Matters News & Notes Release, 14 December 2015.pdf
 
7Dec

AFSPA in Action Newsletter

Read the latest AFSPA news in our AFSPA in Action Fall Newsletter!
AFSPA in Action Fall Newsletter.pdf
 
2Dec

Clinical Matters News & Notes Release

This is an Express Scripts Clinical Matters News & Notes Release, 30 November 2015.pdf
 
1Dec
FROM THE CEO

FROM THE CEO

December marks the end of another year and begins a time of reflection. Every year at this time, I think about how lucky we are at AFSPA to serve such an exceptional group of people. Thank you for giving us the opportunity to work with you this year.

Holidays bring family and friends together to celebrate traditions and spread good cheer. They also bring lots of opportunities for socializing, eating, and drinking. Even the most disciplined of us struggle with temptation during the holiday season. Stay physically active during the holidays. Make your focus on fun and not just on food. Also, be sure to manage your stress levels. Find a balance between work, home, and play. Get support from family and friends, when needed. Keep a relaxed and positive outlook. Above all, get proper sleep. These are just a few holiday tips to support your efforts for health and safety this season. See a full list of recommendations from the Centers for Disease Control and Prevention at http://www.cdc.gov/family/holiday/.

On another note, December 1 marks World AIDS Day. This annual day of reflection is an opportunity for people worldwide to unite in the fight against HIV. Government and health officials, non-governmental organizations, and individuals around the world observe the day. Activities often include education on AIDS prevention and control. The day shows support for people living with HIV and commemorates the people who have died.

Lastly, it is not too early to start thinking about resolutions for 2016. One of our most precious gifts is good health. I hope you have begun considering small changes in your lifestyle that will have a positive effect on the way your feel in 2016.  We have revamped the Wellness Benefits in the FSBP. If you already are a member of the Plan, please take a look at our Simple Steps to Living Well Together Program that helps you identify your health risks and achieve your health goals.

If you are not enrolled in the FSBP, please consider the FSBP for 2016. Open Season doesn’t end until December 14th, so it’s not too late to give yourself a present for 2016 – the gift of the support you need to achieve your 2016 health goals.

In summary, the holidays are a great opportunity to enjoy time with family and friends, to celebrate life, to be grateful, and to assess what is important. But they are also a wonderful time to appreciate the gift of health. I hope you and all family and friends have a lovely holiday season filled with joy and meaning.    

To Your Health,  

Paula S. Jakub, RHU
CEO, AFSPA
Executive Director, Senior Living Foundation


 
30Nov

Portrazza Approved for Lung Cancer

This is an Express Scripts Clinical Flash, 25 November 2015.pdf
 
25Nov
AFSPA is closing early

AFSPA is closing early

Please be advised we will be closing our offices early on Wednesday, November 25, 2015.
Our offices will close at 2:00P.M. EST. and will remain closed through the weekend. 

We will resume normal business hours on Monday, November 30, 2015. 

Happy Holidays! 







 
18Nov

Darzalex Approved for Multiple Myeloma

This is an Express Scripts Clinical Flash,18 November 2015.pdf
 
17Nov

Adynovate Approved for Hemophilia A

This is an Express Scripts Clinical Flash, 17 November 2015.pdf
 
16Nov

Clinical Matters News & Notes Release

This is an Express Scripts Clinical Matters News & Notes Release, 16 November 2015.pdf
 
10Nov

Cotellic Approved for Advanced Melanoma

This is an Express Scripts Clinical Flash,10 November 2015.pdf
 
6Nov

Genvoya Approved for HIV

This is an Express Scripts Clinical Flash, 6 November 2015.pdf
 
5Nov

NUCULA Approved for Severe Asthma

This is an Express Scripts Clinical Flash, 5 November 2015
 
4Nov

Clinical Matters News & Notes Release

 
6Nov
Welcome to the new AFSPA Website!

Welcome to the new AFSPA Website!

Welcome to the new AFSPA Website! After months of planning and preparation, we are pleased to unveil the site to our loyal members. You will find freshly organized content partnered with more pictures and colors that are pleasing to the eye. Of course, we want AFSPA members to continue using the site as a resource. We built the site using a more secure structure to ensure continued access for our members and avoid interruption in service. In addition, we streamlined the presentation of the content, improved the contact forms and search function, and combined the news updates into a single feed. Our goal was to present a website that is easier – and even enjoyable – for members to use.

You can learn important health benefit information as well as more about our ancillary services including dental, disability, and others. This website is more interactive and allows us to hear directly from you. We want to know your thoughts on the new site and your overall experience with AFSPA. You can use the feedback features within the website (at the bottom of the home page, under Resources) or email [email protected].

Thank you for visiting and exploring the new AFSPA site! 
 
1Nov
From the CEO

From the CEO

Welcome to November 2015!

As the year comes to an end, this season makes us focus on planning and preparation for the upcoming year. The Federal Employee Benefits Open Season is fast approaching, which is a great time to take a look at all your benefits.

In addition to reviewing the choices for your health plans, review your dental choices and consider adding dental coverage from AFSPA. AFSPA sponsors four different dental plans. Our plans are designed to provide options to fit how you use dental care. This includes a PPO plan that provides out-of-network benefits, two dental HMO plans that could lower your out-of-pocket expense even more. We also offer an international plan designed exclusively for our overseas members, offering the higher benefit level for treatment abroad. In addition to premiums that are competitive with FEDVIP, our plans provide the necessary flexibility for our members who transfer to/from overseas throughout the entire year and not just during an Open Season/QLE. We encourage you to take a look at our services. Many of you trust us with your medical health care, why not trust us with your dental health care too?

Recently, I have received many questions about the new Self Plus One enrollment type. For those who do not know, Self Plus One is a new enrollment type in the FEHB Program that allows you to cover yourself and one eligible family member you designate to be covered. You will be able to select the Self Plus One enrollment beginning this Open Season. You will want to pay special attention to the benefits and rates in the Foreign Service Benefit Plan (FSBP).

We develop our rates based on the population for each enrollment type in our Plan. Due to demographics, utilization of medical services, and medical costs, the premiums for the Self Plus One and Self and Family are similar. Many plans increased the Self and Family premium substantially to make room for the Self Plus One rate. If you compare the 2015 Self and Family rate to the 2016 Self Plus One rate of many plans in the FEHB Program, you will see that there is a considerable increase. The 2016 Self and Family rate is higher yet, in most cases, to make room for the Self Plus One rate. So, while it seems there should be a break in the Self Plus One premium, in reality, the right amount of premium still is needed to cover the outgoing claims, regardless of the enrollment type.

Please keep in mind: If you are a two person family, you do not have to enroll in Self Plus One. You may remain in Self and Family. Therefore, our focus was on the Self and Family rate, which affects the majority of 
FSBP enrollees. On another note, Open Season begins November 9, 2015. As you know, the AFSPA staff travel to various regions of the globe in preparation for Open Season. Any direct hire Federal employee who is enrolled or is eligible to enroll in any plan under the FEHB Program can attend these briefings, which are focused on general information to explain your Federal benefits and Open Season opportunities. This year’s topics include the Changes in 2016, How Health Care Reform Affects You, and the new Self Plus One Premium – available in 2016. Please plan to attend and bring your questions. See the November schedule below (subject to change – check with your local HR office):

November 2 – Yongsan Army Base, US Army Corps of Engineers, FED Compound, East Gate Club, Building S-87, 9:30am

November 2 – Yongsan Army Base, South Post Chapel, Overflow Room, 9:30am & 1pm

November 2 – Yongsan Army Base, Seoul American Elementary School, Library, 3pm

November 2 – Yongsan Army Base, Seoul Middle/High School, Auditorium, 4pm

November 3 – Osan Air Base, Building 936, Room 214, 1:30pm

November 3 – Osan Air Base, Osan American Elementary School, Library, 3pm

November 4 – Camp Humphreys, Community Fitness Center, Super Gym, 11am & 1pm

November 4 – Camp Humphreys, Camp Humphreys High School, Library, 3:30pm

November 4 – U.S. Consulate General Sao Paulo, Buzios Conference Room, 2:30pm

November 5 – U.S. Embassy Seoul, 1st Floor Conference Room, 9am

November 6 – U.S. Embassy Brasilia, Amazonas Conference Room, 9:30am

November 9 – American Institute Taiwan, Auditorium, 2pm

November 10 – U.S. Embassy Bogota, Florida Room, 2:30pm

November 10 – Camp Walker, Camp Walker Chapel, 9am

November 10 – Camp George, Daegu Elementary School, 2:30pm

November 10 – Camp Walker, Daegu High School, 3:15pm

November 12 – Kadena Air Base, Kadena High School, Library, 4pm

November 12 – U.S. Embassy Lima, Multipurpose Room, 1pm

November 12 – Misawa Air Base, Sollars Elementary School, Library, 3pm

November 13 – Kadena Air Base, Schilling Center, Large Conference Room, 9:30am

November 16 – Kadena Air Base, Schilling Center, Large Conference Room, 9:30am

November 16 – Kadena Air Base, Lester Middle School, Library, 4pm

November 16 – Yokosuka Naval Base, Building A-20, Classroom, 10:30am & 12pm

November 16 – Yokosuka Naval Base, Sullivan School Complex, Multi-Purpose Room, 3pm

November 16 – U.S. Embassy Port Au Prince, Multi-Purpose Room, 2pm

November 17 – Naval Air Facility Atsugi, Classroom 216, Building 949, 10am & 12pm

November 17 – Naval Air Facility Atsugi, Shirley Lanham Elementary, Library, 2:45pm

November 18 – U.S. Embassy Mexico City, Conference Room, 2pm

November 18 – Yokota Air Base, Mendel Elementary, Training Room, 3pm

November 19 – Camp Zama, Training Room, 1pm

November 19 – Camp Zama, Community Club, Garden Room, 3:30pm

November 20 – U.S. Embassy Tokyo, Management Conference Room, 3rd Floor, 9am

We hope to see you at one of our Open Season Briefings.By the way, Happy Thanksgiving! This year, as you celebrate this truly American holiday, thank your body by maintaining a healthy diet during the traditional gatherings. Reduce your salt intake, control your portions, and load your plate with vegetables.

As always, thank you for your trust and for giving us the opportunity to serve you.

To Your Health,

Paula S. Jakub, RHU 

CEO, AFSPA 
Executive Director, Senior Living Foundation
 
19Oct
FSBP Announces 2016 Benefits and Premiums

FSBP Announces 2016 Benefits and Premiums

At a time when the Federal Employees Health Benefits Program has announced average enrollee premium increases of 7.4% (with some of the popular plans increasing even more), we are pleased to announce that we have increased only modestly in comparison. The Foreign Service Benefit Plan (FSBP) Self Only premium went up only 5% and our Self and Family premium went up only 5.4%.

Above
 is a chart showing our enrollees’ share of our premiums for 2016.

Starting in 2016, FEHB enrollees will be able to enroll in the new Self Plus One enrollment type. We announced information about the new Self Plus One enrollment type on our website on several occasions and in our Health Newsletter that we mailed to members recently. OPM has mandated that Self Plus One enrollment codes end in 3 for plans with one option.As with all FEHB plan premiums, OPM must approve them. You will notice that the enrollee’s share of the Self Plus One premium is slightly higher than the enrollee’s share of the Self and Family premium. We realize this sounds counter-intuitive but there are good reasons for this:
  • We develop our rates based on the population for each enrollment type in our Plan. Due to demographics, utilization of medical services, and medical costs, the premiums for the Self Plus One and Self and Family are similar. Because the government contribution for Self Plus One enrollments is smaller than the government contribution for Self and Family enrollments, Self plus One enrollees will pay a higher enrollee contribution than Self and Family enrollees.
  • If you are a two person family, you do not have to enroll in Self Plus One. You may remain in Self and Family. Therefore, our focus was on the Self and Family rate, which affects the majority of FSBP
 
13Oct
ESI System Down Time Planned

ESI System Down Time Planned

On October 18, Express Scripts (ESI - the FOREIGN SERVICE BENEFIT PLAN'S pharmacy benefit manager) is relocating to new state-of-the-art data center facilities. In order to complete the data center relocation, ESI is planning system down time that will occur on Oct. 18, between 2 a.m. ET and 9 a.m. Eastern Time. ESI selected the date and time for the relocation that would have the least amount of impact on clients and members. Potential areas of impact and plans in place to notify users of system maintenance are: Eligibility: Prescriptions will not process during the down time window. Retail pharmacies will be notified in advance to minimize member impact and ensure access to care is not compromised. Pharmacies may use their discretion based on patient need to fill the prescription and process once the system is back up, provide a limited supply or ask the patient to come back once the system is back up.
  • Coverage review: All systems will be unavailable but messaging will be placed on all sites informing users of down time. Phone call and fax volume is expected to be low. Plans to increase staffing resources are in place to complete requests once the system is back up as quickly as possible.
  • Contact centers: Patient care advocates will be unable to assist callers during this time. Information will be included in messaging alerting patients of down time due to system maintenance.
  • Member Website and mobile app: These sites will not be accessible during this time. Messaging will be displayed on all websites prior to the outage, during the outage and post outage once all systems are running as normal.
 
1Oct
From the CEO

From the CEO

Welcome to Fall 2015!
In many parts of the world, this means transitioning from warm weather to cold weather. Please make sure to wear layers of clothing to protect your body. You and your family may want to consider getting a flu shot as well. A flu vaccine is needed every season for two reasons. First, the body's immune response from vaccination declines over time and an annual vaccine is needed for optimal protection. Second, because flu viruses are changing constantly, the formulation of the flu vaccine is reviewed each year and sometimes updated to keep up with changing flu viruses. For the best protection, every family member over the age of six months should get vaccinated annually. The Foreign Service Benefit Plan covers flu shots at 100% when using an in-network provider or an overseas provider.

If you have not heard yet, AFSPA moved to a new location on Monday, September 14, 2015. The address is 1620 L Street NW, Suite 800, Washington, DC 20036. The new office provides ample space for our growing staff and some necessary additions including dedicated space to meet with members and training space. If you are in the DC area, please stop by to see us. We welcome visitors during our normal business hours of Monday through Friday, 8:30am to 4:30pm, Eastern Standard Time. Please see the pictures of the new building in our upcoming Fall (AFSPA in Action) newsletter.

Open Season is fast approaching. This year, the open enrollment period is from November 9 to December 14, 2015. The AFSPA staff always travel to various regions of the globe in preparation for Open Season. Any direct hire Federal employee who is enrolled or is eligible to enroll in any plan under the Federal Employees Health Benefits (FEHB) Program can attend. This year?s topics include the Changes in 2016, How Health Care Reform Affects You, and the new Self Plus One Premium - available in 2016. Please plan to attend and bring your questions. See the October schedule below (subject to change - check with local HR offices):

October 8 - US Embassy, Brussels, HR Conference Room - 9am
October 8 - Brussels American School, Sterrebeck Library - 2:30pm
October 9 - US Embassy, Brussels, JAS 2nd Floor Conference Room - 9:30am
October 13 - Alconbury Middle/High School, Library - 3pm
October 14 - Lakenheath High School, Library - 4pm
October 14 - USAG Grafenwoehr, Civilian Personnel Advisory Center Unit 28130 - 11am
October 14 - Paris Embassy - 11:30am
October 14 - Grafenwoehr - Netzaberg Elementary School Unit 28130, Room E2.124 - 3:15pm
October 15 - US Embassy, London, Ben Franklin Room - 10:30am
October 15 - Hohenfels Civilian Personnel Advisory Center Conference Room, Bldg. 33 - 1pm
October 15 - Hohenfels Elementary School, Media Center - 3:30pm
October 16 - Vilsek, Rose Barracks, Building 535 - 11am
October 19 - Ramstein, USAFE Conference Center Gebaude 525, Flugplatz. Jefferson Ave., Bldg 525 - 1pm
October 19 - Ramstein High School, Library - 3:30pm
October 19 - Vicenza Army Base, Vicenza High School Library - 4pm
October 20 - Kaiserslautern, Panzer Kaserne Building 3029, Room 104 - 9am
October 20 - Kaiserslautern, Panzer Kaserne Building 3029, Room 104 - 11am
October 20 - Kaiserslautern, Pulaski Barracks Info Center, Ktown Middle/High School -? 9am
October 20 - Aviano Air Force Base, Base Theatre (Area F) - 1:30pm
October 21 - Stuttgart, Germany - AFRICOM - Building 3313, Room 115-116 - 9am
October 21 - Stuttgart, Germany - Patch Barracks - Theater - 11:30am
October 21 - Stuttgart, Germany - Stuttgart High School - 4pm
October 22 - Rome Embassy, Conference Room - 10am
October 22 - Wiesbaden, Building 1032, Room 2 - 11am
October 22 - Wiesbaden Middle School, Info Center - 4pm
October 23 - Frankfurt Consulate, Flag Room - 1pm
October 27 - Naples Navy Base, CAPO Theater - 9am
October 27 - Naples Elementary, Media Center - 2:45pm

We hope to see you at one of our Open Season Briefings.By the way, Happy Halloween! Here is a health tip: Set an expiration date for your candy, such as seven days after the holiday. You can throw it out or consider donating it to a food pantry or organization that sends treats to troops overseas. This health tip comes directly from the Cleveland Clinic.As always, thank you for your trust and for giving us the opportunity to serve you.

To Your Health, 

Paula S. Jakub, RHU
CEO, AFSPA 
Executive Director, Senior Living Foundation

 
8Oct
Travel in Style

Travel in Style

Whether you're traveling with your family or you have planned excursions for your retirement years, it is important to consider a solid travel insurance plan. While no one wants to think anything would happen while vacationing, it is always better to be prepared rather than to be surprised.

AFSPA offers the Travel Assistance International travel policy that fills in the blanks where your health insurance may not cover. For example, repatriation of remains to your family, emergency medical evacuation, pre-trip assistance, emergency cash advances, and many more services are included in this policy.

A standard travel insurance policy contains many different sections of coverage, not all of which everyone needs, but for most people a standard travel insurance policy will cover all the unexpected events that can occur while away from home.

All travel insurance services are available 7 days a week, 24 hours a day. Help is only a telephone call away! For more information, contact us at (202) 833-4910 or call Travel Assistance International at 1 (800) 821-2828.
 
8Oct
Choosing a Dental Office

Choosing a Dental Office

Many people do not know who to select for their dental provider, therefore, they just don't! Anxiety is a strong emotion we experience when it comes to deciding to go to the dentist or not.There are several ways to approach selecting a dentist. When you are searching for a dentist, the American Dental Association (ADA) offers these suggestions:
  • Ask family, friends, neighbors, or co-workers for their recommendations.
  • Ask your family doctor or local pharmacist.
  • If you are moving, ask your current dentist to make a recommendation.
  • Contact your local or state dental society. The ADA provides a list of local and state dental societies on its web site, www.ada.org. Your local and state dental societies also may be listed in the telephone directory under 'dentists' or 'associations.
The ADA suggests calling or visiting more than one dentist before selecting one.
 
8Oct
The Need to Plan

The Need to Plan

Planning for the future is something we do daily, whether we are aware of it or not. We plan for dinner, for doctor/dental appointments, and even for the occasional vacation.

Planning for your later years, in regards to retirement and healthcare needs, should be considered as well. Think a Long Term Care plan at age 40 and above. This is important, as we are healthier in our forties and the premiums are lower. Applicants over the age 50 may have acquired health issues and the premium rates are much higher. Whatever age you decide to purchase a Long Term Care plan, it is important  to make an educated decision. Call (202) 833-4910 for more information. You will be happy you did!
 
8Oct
Renting your house?

Renting your house?

Own a home? If you are assigned overseas, learn your rights as it relates to renting your home. Tenant-landlord issues can be especially challenging when you are abroad.

One option is to hire a management firm to handle your property issues while you are out of the country. They will act on your behalf regarding maintenance of your property, collection of rent, and any other emergency issues that may occur. To select a reputable management company, you may want to contact a real estate attorney. They can offer guidance in the selection of an adequate service.

For real estate and a variety of other legal matters, AFSPA has several law firms that have specialties to assist members with whatever situation comes their way. Call (202) 833-4910 for more information.
 
8Oct
Insuring Dependent Adults

Insuring Dependent Adults

Are you getting ready for your next assignment overseas? Do you have a dependent adult (either a child over age 26 or a parent) that will be joining you at your new post? If so, consider the Reside or Reside Prime travel medical plans to provide coverage for the period of time they are with you overseas. These plans are also for significant others that are in need of medical insurance that will accompany you.

We provide you with the complete outlines of coverage, premium rates, and applications. Once submitted, applications will be considered within two business days by the program administrator, Seven Corners. For more information, please call (202) 833-4910.
 
8Oct
Disability Insurance: The Overlooked Benefit

Disability Insurance: The Overlooked Benefit

'A penny saved is a penny earned.' Many have heard that saying but most of us do not practice it. If we are realistic, we know anything can happen at any time to threaten our health and financial well-being. If you are unable to work, do not spend your savings - purchase a disability plan. The coverage will help to support  you and your family adequately.

Purchase a disability policy to prevent financial difficulty when illness or injury occurs. This investment will be more than its weight in gold. For just a few dollars a month, a disability plan will provide a new sense of security. You will know you can continue to take care of yourself and your family, even if your employer pays a limited portion of your salary.

Proper planning is key!
 
8Oct
Live in the Moment

Live in the Moment

Life insurance is not only for the future, but also for the present. A life insurance policy will assist your family with covering mortgage, every day bills, and education expenses after a spouse has passed away. Did you know it also can provide a ?living benefit??

Our term life insurance plan provides an Accelerated Benefit Option. This allows early access to benefits that would eventually be paid at death. You can use the benefit in any way you wish ? to pay medical bills, hire home health aides, or prepay funeral expenses. This benefit is payable to you if you are diagnosed with a terminal illness and have a life expectancy of nine months or less. This benefit will pay 50% of your coverage amount up to $50,000. The balance of your benefit (if any) will be paid after your death.

Be aware how your insurance plan can work for you when you need it. If you have questions, please call (202) 833-4910 or email [email protected]
 
8Oct

Term Life Insurance for $2 per pay period

Are you willing to forfeit buying soda once every two weeks? Are you willing to spend that $2 saved toward an all-important term life insurance benefit? That is all that the Immediate Benefit Plan cost, $2 per pay period!

This insurance plan provides $15,000 of coverage ($7,500, if you are over age 70) within two days after AFSPA is notified of your passing. It is payable to your designated beneficiary to cover those immediate costs such as funeral expenses, mortgage, and medical bills.

Applying for this term life insurance plan is easy. Just go to https://www.afspa.org/aip_detail.cfm?page=Immediate-Benefit and follow the instructions under secure enrollment. The brochure outlining coverage is available online.
 
21Sep
A New Home for AFSPA

A New Home for AFSPA

After more than two decades in our previous location, AFSPA opened its new office at 1620 L Street NW, Suite 800, in Washington, DC on September 14, 2015. The location convenient to four Metro lines and in the heart of the DC's Golden Triangle enables us to remain accessible to the membership. The new office provides ample space for our growing staff and some necessary additions including dedicated space to meet with members and training space.

As we look to the future, this move will allow us to continue to provide the unparalleled service that our unique, worldwide membership requires.
 
11Sep

AFSPA IS MOVING!

We will be moving to our new office located at 1620 L Street NW, Suite 800, Washington DC, 20036-5629. Our phones will be down from 1pm (EST) today and will be back up at 1pm (EST) on Monday, September 14. Your access to the Member Portal will not be interrupted and we will respond to any correspondence after 1pm on Monday. We apologize for any inconvenience.
 
1Sep
From the CEO

From the CEO

Traditionally, we mark September, and specifically Labor Day, as the end of summer. Children and adults make major adjustments around this time of year. As kids head back to school, they will need help transitioning into their regular fall routine. This is also a good time to visit the pediatrician and the dentist to ensure a successful and healthy school year.

Along the same lines, please make sure your children are up-to-date on vaccines before sending them back to school. According to the Centers for Disease Control and Prevention (CDC), school-age children, from preschoolers to college students, need vaccines. Making sure that your child is vaccinated can be one of the most important things you do as a parent.  This affects your child?s long-term health?as well as the health of their friends, classmates, and others in your community. The Foreign Service Benefit Plan (FSBP) covers childhood immunizations recommended by the American Academy of Pediatrics for members under age 22. We also cover travel immunizations recommended by the CDC at 100% of the Plan allowance.

Did you move over the summer? If so, please let us know. As you prepare to leave one post for another, please send us your new address. Your employing agency does not notify the FSBP when you change your contact information. Please remember to send us a note with your updated mailing address, telephone number(s), and email address. You also can update your contact information via the Member Portal. To access the Member Portal, click on the AFSPAconnect link in the top right-hand corner, log in, and edit your information in the Member Profile section.  We want to be sure you receive your reimbursement checks and member communications in a timely manner. Please tell us if you change locations so we can stay in touch.

Lastly, September is National Cholesterol Education Month. This is a good time to get your blood cholesterol checked and take steps to lower it if it is high. The National Cholesterol Education Program (NCEP) recommends that adults age 20 years or older have their cholesterol checked every 5 years. Children, young adults and older Americans can have high cholesterol. Preventive guidelines for cholesterol screening differ, but experts agree on the need to screen adults who have other risk factors for coronary heart disease ? obesity, smoking, high blood pressure, diabetes, and family history. This is a great time to get your cholesterol checked and to learn how to prevent high cholesterol in the future. FSBP covers a blood cholesterol and/or lipid panel/profile per person, per calendar year at 100% of Plan allowance. See more preventative care information in our upcoming Health Newsletter.

And speaking of the newsletter, please look out for our Health Newsletter in your mailbox. It is redesigned and restructured to better meet your needs. Let us know what you think of the new format by emailing[email protected]

As always, thank you for your trust and for giving us the opportunity to serve you.

To Your Health,

Paula S. Jakub, RHU
CEO, AFSPA
Executive Director, Senior Living Foundation
 
1Aug
Message from the CEO

Message from the CEO

Greetings and Welcome to August 2016! That means summer is winding down and a new school year is coming quickly. This is a good time to visit the pediatrician and the dentist to ensure a successful and healthy school year.

Along the same lines, please make sure your children are up-to-date on vaccines before sending them back to school. According to the Centers for Disease Control and Prevention, all school-age children need vaccines. The Foreign Service Benefit Plan (FSBP) covers immunizations recommended by the American Academy of Pediatrics at 100% when obtained at an in-network provider or providers outside the 50 Untied States. Having your child vaccinated can be important as it can affect their long-term health.

FSBP is seeking accreditation through the Accreditation Association for Ambulatory Health Care, Inc. (AAAHC). The surveyors will be onsite August 17 -19, 2016. We voluntarily requested this survey as a means of assisting our own efforts to improve the quality of health care and member services. FSBP has been preparing for the accreditation process for over a year. We are confident that our health plan will be evaluated favorably. Seeking this accreditation status is part of our ongoing “Commitment to Service” to you.

Lastly, have you moved? If so, please let us know. As you prepare to leave one post for another, please send us your new address. Your employing agency does not notify FSBP when you change your contact information. Please send a note with your updated mailing address, telephone number(s), and email address. You also can change your contact information via the Member Portal.

Look for your Summer Newsletter in the mail. It highlights AFSPA’s activities, services, and new programs, provides information on prescription drugs and offers suggestions on avoiding “ransomware” attacks. We also share some tips on how to manage stress effectively.

As always, thank you for your trust and for giving AFSPA the opportunity to serve you.

To Your Health,

Paula S. Jakub, RHU
CEO, AFSPA
Executive Director, Senior Living Foundation