Clinical Insights: November 13, 2017

    Welcome to the weekly edition of RxStrategies Clinical Insights, designed to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy market place.


    New Drug Approval

    Heplisav-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)] – New Vaccine Approval – November 9, 2017 – Dynavax Technologies Corporation announced that the U.S. Food and Drug Administration (FDA) has approved Heplisav-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)] for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. Heplisav-B is the first new hepatitis B vaccine in the United States in more than 25 years and the only two-dose hepatitis B vaccine for adults. Read more.

    Prevymis™ (letermovir) – New Drug Approval – November 8, 2017 – Merck & Co., Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Prevymis™ (letermovir) once-daily tablets for oral use and injection for intravenous infusion. Prevymis™ is indicated for prophylaxis (prevention) of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT). Read more.

    Vyzulta™ (latanoprostene bunod) – New Drug Approval – November 2, 2017 – Valeant Pharmaceuticals International, Inc.’s wholly owned subsidiary, Bausch + Lomb, and Nicox S.A. announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Vyzulta™ (latanoprostene bunod ophthalmic solution, 0.024%). Vyzulta™, the first prostaglandin analog with one of its metabolites being nitric oxide (NO), is indicated for the reduction of intraocular pressure (IOP) in patients with open‐angle glaucoma or ocular hypertension. Read more.

    Calquence™ (acalabrutinib) – New Drug Approval – October 31, 2017 – The Food and Drug Administration granted accelerated approval to acalabrutinib (Calquence, AstraZeneca Pharmaceuticals Inc. under license of Acerta Pharma BV) for treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Read more.


    New Formulation Approval

    Varubi® (rolapitant) injectable emulsion – October 25, 2017 – TESARO, Inc., an oncology-focused biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has approved Varubi® (rolapitant) IV in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. Delayed nausea and vomiting can occur anytime between 25 and 120 hours following chemotherapy, and is often extremely debilitating. Read more.


    New Indication Approval

    Sprycel® (dasatinib) – November 9, 2017 – The Food and Drug Administration granted regular approval to dasatinib (SPRYCEL, Bristol-Myers Squibb Co.) for the treatment of pediatric patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase. Read more.

    Adcetris® (brentuximab vedotin) – November 9, 2017 – The Food and Drug Administration granted regular approval to brentuximab vedotin (ADCETRIS, Seattle Genetics, Inc.) for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy. Read more.

    Alecensa® (alectinib) – November 6, 2017 – The Food and Drug Administration granted regular approval to alectinib (ALECENSA, Hoffmann-La Roche, Inc./Genentech, Inc.) for treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), as detected by an FDA-approved test. Read more.

    Zelboraf® (vemurafenib) – November 6, 2017 – The Food and Drug Administration granted regular approval to vemurafenib (ZELBORAF, Hoffmann-La Roche Inc.) for the treatment of patients with Erdheim-Chester Disease (ECD) with BRAF V600 mutation. This is the first FDA-approved treatment for ECD. Read more.

    Xarelto® (rivaroxaban) – October 30, 2017 – Janssen announced that the Food and Drug Administration (FDA) has approved the 10mg dosage strength of Xarelto® (rivaroxaban) for reducing the continued risk for recurrent venous thromboembolism (VTE) after completing ≥6 months of initial anticoagulant therapy. Read more.


    New Drug Shortage

    November 9, 2017 

    November 6, 2017 

    November 3, 2017 

    November 2, 2017 

    November 1, 2017 


    New Drug Recall and Safety Alerts

    Midazolam Injection, USP, 2 mg/2 mL by Fresenius Kabi – Drug Recall Alert – November 3, 2017 – Fresenius Kabi USA is voluntarily recalling Lot of Midazolam Injection, USP, 2 mg/2 mL packaged in a 2 mL prefilled single-use glass syringe to the hospital/user level. The product mislabeled as Midazolam Injection, USP, 2 mg/2 mL contains syringes containing and labeled as Ondansetron Injection, USP, 4 mg/2 mL. The affected Lot is 6400048. Read more.


    New First Time Generic

    No new updates.


    Clinical and Pharmacy News

    Cough Treatment Guidelines Due to Common Cold Updated – November 11, 2017 – There has been little change in the treatment recommendations for cough due to the common cold since publication of guidelines in 2006, according to a review published online Nov. 7 in Chest. Read more.

    Landmark Study May Impact Standard Stroke Treatment Guidelines – November 11, 2017 – Standard guidelines for stroke treatment currently recommend clot removal only within six hours of stroke onset. But a milestone study with results published in the New England Journal of Medicine shows that clot removal up to 24 hours after stroke led to significantly reduced disability for properly selected patients. Read more.

    USPSTF Updates Recommendations for Osteoporosis Screening – November 10, 2017 – In an updated draft recommendation statement, the United States Preventive Task Force (USPSTF) provided guidelines for clinicians on osteoporosis screening to prevent fractures. The Task Force’s recommendations, which are an update to the previous 2011 guidelines, are based on review of the quality of evidence available to advise healthcare providers when screening of osteoporosis is appropriate. Read more.

    Kmart Pharmacy Announces Low Copays for Medicare Part D Members – November 9, 2017 – Kmart Pharmacy may now become a favorite for Medicare Part D members in 2018. The company has announced it will be providing pharmaceutical needs to patients that include copays as low as $1 when filling their prescriptions. Medicare Part D members are being encouraged to enroll in Kmart’s free Pharmacy Rewards program, and those who are already Shop Your Way members can get $5 FREECASH points whenever a prescription is filled. Read more.

    Half of Providers Tie Diabetes Treatment Success to Managing Patient’s Emotions – November 9, 2017 – Major portions of the American population with diabetes believe that their care requires much more than medicine, including emotional support and lifestyle management, and that diabetes care reimbursement needs to be broadened, according to a Novo Nordisk survey published Wednesday. The survey, called Diabetes 360, found that nearly half (45 percent) of healthcare practitioners surveyed tied their success in caring for people with diabetes to their ability to understand and manage the emotional issues their patients face. Read more.

    Ten Ways Hospitals Can Manage Rising Drug Costs – November 9, 2017 – Despite efforts to control costs, the tab for American healthcare continues to climb, and pharmaceuticals take up about 15 percent of the total. Healthcare costs reached $3.2 trillion in 2015, according to CMS. Prescription drug sales accounted for $448.8 billion of total health costs in 2016—a 5.8 percent increase over 2015 totals, half of which came from price hikes rather than increased prescriptions, according to a 2017 report on drug prices, published in the American Journal of Health-System Pharmacy. Read more.

    Study Highlights Opportunities for Pharmacies to Help Curb U.S. Opioid Epidemic, Bolster Other Public Health Efforts – November 8, 2017 – Strategic changes to government policy would present new opportunities for pharmacies in the United States to expand their already important role in critical initiatives that benefit public health, according to a study by the Johns Hopkins Center for Health Security and funded by the National Association of Chain Drug Stores (NACDS). The study, “Serving the Greater Good: Public Health and Community Pharmacy Partnerships,” found the collective group of chain and independent U.S. pharmacies remain an untapped resource in the effort to curb the national opioid crisis, stem the spread of antibiotic resistance, and strengthen pandemic and emergency preparedness and response. Read more.

    Controversy Heats Up Over Pharmacy Benefit Manager DIR Fees – November 8, 2017 – Pharmacy benefits managers (PBMs) are in hot water again if small and specialty pharmacies’ voices can be heard. Besides a litany of complaints from various pharmacy industry stakeholders about PBM operations and business tactics—from a lack of transparency to controlling formularies—now PBMs are being accused of retroactively applying direct and indirect remuneration fees (DIR) to pharmacies. Read more.

    Privatizing Medicaid Pharmacy Benefits Can Save States Money, Study Says – November 8, 2017 – State Medicaid programs could see drug spending drop considerably by fully privatizing the delivery of pharmacy benefits, according to a recent study. Before the Affordable Care Act, states maintained their public pharmacy benefits programs separately even as they increasingly shifted coverage for medical services to private insurers, noted the study (PDF), which was published in the National Bureau of Economic Research. Read more.

    Six Ways Amazon Could Reshape the Pharmacy Business – November 8, 2017 – The pharmacy market is one of the biggest potential new targets for The online retail giant moved into the roughly $800 billion U.S. grocery market in June by buying Whole Foods Market. Pharmaceuticals, a $450 billion industry in the U.S., are likewise most often sold from brick-and-mortar stores. Shoppers filling prescriptions frequently pick up toiletries, beauty supplies and dish soap—all retail items Amazon already sells. And the distribution chain for drugs has lots of middlemen whose markups Amazon can seek to undercut. Read more.

    Pharmacists Should Expect Increasing Use of Biosimilars to Lower Costs – November 8, 2017 – Increasing use of biosimilar drugs will lead to even greater cost-saving than previously estimated. That’s according to a new RAND Corporation report suggesting that biosimilar versions of complex biologic drugs could drive down U.S. healthcare spending by $54 billion over the next 10 years. Read more.

    Pharmacies, PBMs, Insurers Call for Opioid Prescription Policy Changes – November 8, 2017 – Drug prescribers throughout the country should establish a seven-day supply limit for initial opioid prescriptions, and they should be written electronically to slow the abuse of the addictive painkillers, a group of pharmacies, pharmacy benefit managers and health plans wrote in a letter to President Donald Trump Wednesday. The group pledged to support the federal government and states in clamping down on behaviors that have allowed opioid abuse to swell into a national epidemic. Read more.

    Record Number of Pills Collected on Prescription Drug Take Back Day – November 7, 2017 – On October 28, 2017, pharmacies and police stations nationwide participated in the Drug Enforcement Administration’s (DEA) 14th National Prescription Drug Take Back Day, and received a record number of unused prescription drugs, the DEA announced in a press release. The event provides an opportunity for the public to dispose of any potentially dangerous expired, unused, and unwanted prescription medications at various collection sites around the country. This year, the public returned a record-setting 912,305 pounds of prescription pills, bringing the total amount of prescription drugs collected by the DEA since 2010 to 9,015,668, or 4508 tons. Read more.

    One Million Medicare Part D Enrollees Had Out-of-Pocket Drug Costs above the Catastrophic Threshold in 2015 – November 7, 2017 – One million Medicare beneficiaries had out-of-pocket drug spending above the Part D catastrophic threshold in 2015, and the number with such high spending has risen sharply in recent years, according to a new analysis by the Kaiser Family Foundation. Read more.

    This Is How Amazon Could Invade the Pharmacy Business – November 7, 2017 – The pharmacy market is one of the biggest potential new targets for Inc. The online retail giant moved into the roughly $800 billion U.S. grocery market in June by buying Whole Foods Market Inc. Drugs, a $450 billion industry in the U.S., are likewise most often sold from brick-and-mortar stores. Shoppers filling prescriptions frequently pick up toiletries, beauty supplies and dish soap—all retail items Amazon already sells. And the distribution chain for drugs has lots of middlemen whose markups Amazon can seek to undercut. Read more.

    JTFPP Guidelines Offer Practical Advice on Medications to Treat Seasonal Allergic Rhinitis – November 7, 2017 – In a newly updated clinical practice guideline, published in Annals of Allergy, Asthma and Immunology, allergists offer practical advice on the best types and amounts of medications to treat seasonal allergic rhinitis. Annals is the scientific publication of the American College of Allergy, Asthma and Immunology (ACAAI). Read more.

    CVS Is Rolling Out Free Same-Day Prescription Delivery – November 6, 2017 – CVS Health will start delivering prescriptions to customers’ doors for free in early 2018 in an effort to offset declining in-store sales and help maintain its dominance as Amazon considers diving into the pharmacy business. CVS announced Monday it will offer free next-day prescription delivery from all 9,700 store locations next year. The drugstore giant will provide same-day prescription delivery in select markets, including Miami, Boston, Philadelphia, Washington, DC and San Francisco in early 2018. Read more.

    Drug Distributor Mckesson To Buy CVS Health’s Services Unit – November 6, 2017 – Drug distributor McKesson Corp (MCK.N) said it would buy drugstore operator CVS Health Corp’s (CVS.N) unit that provides various tailored services to pharma firms in a $735 million deal to expand the range of services it offers. The unit, RxCrossroads, provides reimbursement support, integration with network pharmacies, patient adherence programs, specialty logistics services, sales operations support and mail-order pharmacy services. Read more.


    340B in the News

    CMS Plan to Slash 340B Payments Under Fire by Hospitals – November 9, 2017 – CMS will significantly slash drug payments to hospitals that use the 340B Drug Pricing Program by $1.6 billion. The changes, under the “Hospital Outpatient Prospective Payment (OPP) and Ambulatory Surgical Center Payment Systems and Quality Reporting Program” final rule, take effect January 1. Read more.

    Hospitals and PhRMA Face Off Over Drug Prices And 340B Program – November 9, 2017 – President Donald Trump promised to crack down on drug companies “getting away with murder,” but it turns out that it’s hospitals taking it on the chin over the cost of medicine. There’s a big, expensive fight brewing between the two powerful lobbies around a somewhat obscure drug discount program called 340B. Read more.

    CMS Final Rule Will Reduce Medicare Part B Drug Payments by Nearly 30% for 340B Hospitals – November 7, 2017 – On November 1, 2017, the Centers for Medicare & Medicaid Service (“CMS”) released the Medicare Hospital Outpatient Prospective Payment System (“OPPS”) final rule (“Final Rule”), finalizing a Medicare payment reduction from Average Sales Price (“ASP”) + 6% to ASP – 22.5%, for 340B discounted drugs in the hospital outpatient setting, as was proposed in the OPPS proposed rule earlier this year. This payment reduction is effective January 1, 2018, and would primarily impact disproportionate share hospitals, rural referral centers, and non-rural sole community hospitals. Read more.

    Newly-Announced 340B Payment Rule Presents Financial & Operational Challenges to All Covered Entities – November 6, 2017 – In its 2018 Outpatient Prospective Payment System final rule (Final Rule) issued Nov. 1, Centers for Medicare and Medicaid Services (CMS) implemented a significant Medicare Part B payment reduction for separately payable, non-pass-through drugs provided in the hospital outpatient setting. CMS also finalized several new modifiers that will present significant operational challenges, given a very short turnaround time to implement. Read more.

    Hospital Groups to Sue CMS over $1.6 Billion Cut to 340B Program – November 1, 2017 – The nation’s leading hospital associations are banding together to sue the CMS over the agency’s plan to slash 340B drug payments to hospitals. Less than an hour after the CMS released the final rule, America’s Essential Hospitals, the American Hospital Association and the Association of American Medical Colleges said they believe the agency has overstepped its statutory authority by cutting 340B drug payments by $1.6 billion, or 22.5 percent less than the average sales price. Read more.