Clinical Insights: June 2, 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

    Rebinyn® (Coagulation Factor IX (Recombinant), GlycoPEGylated) – May 31, 2017 – Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application for REBINYN® (Coagulation Factor IX (Recombinant), GlycoPEGylated) for the treatment of adults and children with hemophilia B. Read More.

    Zerviate™ (cetirizine ophthalmic solution) 0.24% – May 31, 2017 – Nicox S.A., announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Zerviate™ (cetirizine ophthalmic solution 0.24%; formerly AC-170) the first topical ocular formulation of this well-known antihistamine, for the treatment of ocular itching associated with allergic conjunctivitis. Read More.

    New Formulation Approval

    Isentress® HD (raltegravir) – May 30, 2017 – Merck announced that the U.S. Food and Drug Administration (FDA) has approved Isentress® HD, a new 1200 mg once-daily dose of the company’s integrase inhibitor, Isentress® (raltegravir), to be administered orally as two 600 mg film-coated tablets with or without food, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg, who are treatment-naïve or whose virus has been suppressed on an initial regimen of Isentress® 400 mg given twice daily. Read More.

    New Indication Approval

    Zykadia™ (ceritinib) – May 26, 2017 – The U.S. Food and Drug Administration (FDA) granted regular approval to ceritinib (ZYKADIA®, Novartis Pharmaceuticals Corp.) for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. Read More.

    New Generic Drug Approval

    Atomoxetine (Strattera®) – May 30, 2017 – The U.S. Food and Drug Administration approved the first generic versions of Strattera® (atomoxetine) to treat attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult patients. Read More. 

    Nebivolol (Bystolic®) – May 29, 2017 – Glenmark Pharmaceuticals Inc., USA (Glenmark) has received final approval from the United States Food & Drug Administration (FDA) for nebivolol tablets, 2.5 mg, 5 mg, 10 mg and 20 mg, the generic version of Bystolic tablets, 2.5 mg, 5 mg, 10 mg and 20 mg, of Forest Laboratories, LLC. With respect to 180-day generic drug exclusivity, the FDA noted that Glenmark was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for nebivolol tablets, 2.5 mg, 5 mg, 10 mg, and 20 mg. Therefore, with this approval, Glenmark may be eligible for 180 days of generic drug exclusivity for nebivolol tablets, 2.5 mg, 5 mg, 10 mg, and 20 mg. Read More.


    New Drug Shortages/Updates

    New Drug Recall Alert

    Brilinta® (ticagrelor) – May 26, 2017 – AstraZeneca is notifying physicians and consumers that it is voluntarily recalling one lot of professional (physician) sample bottles containing eight tablets of Brilinta (ticagrelor) 90 mg tablets as a precautionary measure. This voluntary recall follows a report that a professional sample bottle containing eight tablets of Brilinta 90 mg also contained another medicine called Zurampic (lesinurad) 200 mg tablets, which is also manufactured by AstraZeneca. Read More.

    Mibelas™ 24 FE (norethindrone/ethinyl estradiol and ferrous fumarate) – May 25, 2017 – Lupin Pharmaceuticals Inc. announced a recall of lot L600518, Exp 05/18 of Mibelas 24 Fe (Norethindrone Acetate and Ethinyl Estradiol 1 mg/0.02 mg chewable and ferrous fumarate 75 mg) Tablets at the consumer level. A confirmed market complaint indicated a packaging error, where the blister was rotated 180 degrees within the wallet, reversing the weekly tablet orientation and making the lot number and expiration date no longer visible. Read More.

    Clinical and Pharmacy News

    Statins Not Beneficial for Primary Prevention in Some Older Users – May 31, 2017 – Questions are being raised about the usefulness of statins to prevent adverse cardiovascular and mortality outcomes in older adults with hypertension and moderately high cholesterol. Read More. 

    A Drug Quintupled in Price. Now, Drug Industry Players Are Feuding Over the Windfall. – May 31, 2017 – A company that manages prescription drug plans for tens of millions of Americans has sued a tiny drug maker that makes an emergency treatment for heroin and painkiller overdoses, increasing the tension between the companies that make drugs and those that decide whether they should be covered. Express Scripts, the nation’s largest pharmacy benefits manager, is suing Kaléo, the manufacturer of Evzio, the injectable overdose treatment whose price quintupled last year, drawing widespread outrage and inquiries from members of Congress. Read More. 

    Association of Prescription Drug Price Rebates in Medicare Part D with Patient Out-of-Pocket and Federal Spending – May 30, 2017 – The increasing cost of prescription drugs is a burden for patients and threatens the financial stability of the U.S. health care system. Rebates are a form of price concession paid by a pharmaceutical manufacturer to the health plan sponsor or the pharmacy benefit manager working on the plan’s behalf. Proponents argue that rebates result from vigorous negotiations that help lower overall drug costs. Critics argue that rebates have perversely increased the costs patients pay out of pocket, as well as the costs for Medicare as a whole. Read More.

    Congress Mulls Major Drug-Pricing Proposals – May 30, 2017 – Several bills aimed at controlling the high cost of prescription drugs are slowly wending their way through Congress, according to an article in The New York Times. Here’s a list of the major drug-pricing proposals currently under consideration. Read More.

    ACP: Updated Osteoporosis Treatment Guidelines – May 30, 2017 – The American College of Physicians (ACP) has updated its 2008 guidelines on treating low bone density and osteoporosis to prevent fractures in men and women. This updated guideline is endorsed by the American Academy of Family Physicians and was published in the Annals of Internal Medicine. Read More.

    Updates to NSCLC Guidelines Make Testing at Diagnosis, Resistance Essential – May 30, 2017 – Updates to the National Comprehensive Cancer Network (NCCN) guidelines for the management of advanced non–small cell lung cancer (NSCLC) stress the importance of multiplexed biomarker testing at diagnosis to aid in the selection of appropriate first-line and subsequent lines of therapy, said presenters at the 2017 NCCN Annual Conference. Read More.

    Drug Lobbyists’ Battle Cry Over Prices: Blame the Others – May 29, 2017 – Hundreds of independent pharmacists swarmed the House and Senate office buildings one recent afternoon, climbing the marble staircases as they rushed from one appointment to the next, pitching lawmakers on their plan to rein in the soaring drug prices that have enraged American consumers. Read More.

    Biologic Therapy Not Cost-Effective for RA After Methotrexate Fails – May 29, 2017 – Initiating biologic therapy in patients with rheumatoid arthritis when methotrexate monotherapy fails increases costs substantially and provides minimal incremental benefit compared with triple therapy, according to data published in Annals of Internal Medicine. Read More.

    FDA’s Gottlieb Reveals Plans to Tackle Generic Price Abuses – May 26, 2017 – Earlier this month Gottlieb revealed first details of an initiative to tackle the tragedy of opioid addiction in the US, and in line with promises by President Trump, he has now moved on to the controversial issue of price gouging. Read More.

    Middlemen Are Not Passing on All Drug Discounts Intended for Patients – May 26, 2017 – Over 400,000 Americans with cancer suffer from a second disease – “financial toxicity.” The symptoms include missed mortgage and rent payments, raided retirement accounts and decisions about whether to take medicines as prescribed or ration them to save money. Such choices can be deadly. Read More.

    FDA Advisory Committee Recommends Approval for New Biosimilar of Epogen/Procrit – May 26, 2017 – The FDA Oncologic Drugs Advisory Committee has recommended that Pfizer’s epoetin alfa biosimilar be approved across all indications. This marks the first time that a biosimilar erythropoiesis-stimulating agent has been recommended for approval by an FDA advisory committee. Read More.

    U.S. Death Rates from Alzheimer’s Disease Increased 55 Percent from 1999 to 2014 – May 26, 2017 – Death rates from Alzheimer’s disease increased 55 percent between 1999 and 2014, according to data released by the CDC (MMWR Morb Mortal Wkly Rep 2017 May 25. [Epub ahead of print]). Read More.

    CVS, Abbott, Others Accused of Price Fixing Blood Sugar Tests – May 25, 2017 – The three largest U.S. pharmacy benefit managers and four leading pharmaceutical companies are accused in a new proposed class action of colluding to fix prices for glucose test strips (Prescott v. CVS Health Corp., W.D. Wash., No. 2:17-cv-00803, complaint filed 5/24/17). Read More.

    340B in the News

    Senator Grassley Tours Facilities and Answers Questions at Pella Regional Health Center – June 1, 2017 – U.S. Senator Chuck Grassley was at Pella Regional Health Center Wednesday afternoon to tour the facility and answer questions. Grassley discussed the 340B prescription drug program with professionals as part of his visit. Grassley tells KNIA/KRLS News he supports 340B in its current form after he says there were issues with the program earlier this decade. Read More.

    HRSA Pushes Back 340B Rule Implementation Until October 1, 2017 – May 31, 2017 – Changes to the rules governing calculation of the ceiling price and application of civil monetary penalties under the 340B Drug Pricing Program will not be implemented until October 1, 2017 under a rule published by the Health Resources and Services Administration (HRSA) on May 19, 2017. Read More.

    Dr. Neil Minkoff Discusses Evolution and Consequences of 340B Programs – May 30, 2017 – The 340B program has evolved significantly since its passage, but there are still important changes needed, like clarifying the target patient population. The complicated rebate system for payers and drug manufacturers is also a consequence that should be addressed, said Neil Minkoff, MD, chief medical officer of EmpiraMed. Read More.

    Trump Administration Wants to Overhaul Drug Discounts for Hospitals – May 30, 2017 – The Trump administration’s 2018 budget envisions big changes to a drug-pricing program that offers discounts to hospitals and other providers. The president’s budget request for fiscal year 2018 released May 23 directs the Department of Health and Human Services to work with Congress to develop a       legislative proposal to improve the 340B Drug Pricing Program’s “integrity and ensure that the benefits derived from participating in the program are used to benefit patients, especially low-income and uninsured populations.” Read More.