Clinical Insights: May 9, 2018

    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

    Plenvu® (polyethylene glycol 3350 with electrolytes) – May 7, 2018 – Salix Pharmaceuticals, Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved Plenvu® (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride for oral solution), a lower-volume (1L) polyethylene glycol based (PEG) bowel preparation. Read more.


    New Formulation Approval

    No new updates.


    New Indication Approval

    Darzalex® (daratumumab) – New Expanded Indication Approval – May 8, 2018 – Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved Darzalex® (daratumumab) in combination with Velcade® (bortezomib)*, a proteasome inhibitor (PI); melphalan, an alkylating agent; and prednisone – VMP – for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). Read more.

    Kymriah® (tisagenlecleucel) – New Indication Approval – May 1, 2018 – Novartis announced the U.S. Food and Drug Administration (FDA) has approved Kymriah® (tisagenlecleucel) suspension for intravenous infusion for its second indication – the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. Kymriah® is not indicated for the treatment of patients with primary central nervous system lymphoma. Read more.

    Tafinlar® (dabrafenib) and Mekinist® (trametinib) – New Indication Approval – April 30, 2018 – The Food and Drug Administration granted regular approval to dabrafenib (TAFINLAR, Novartis Pharmaceuticals Corp.) and trametinib (MEKINIST, Novartis Pharmaceuticals Corp.) in combination for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection. Read more.


    New Drug Shortage

    May 8, 2018 

    May 3, 2018 

    May 2, 2018 

    April 30, 2018 


    New Drug Recall and Safety Alerts

    Piperacillin and Tazobactam for Injection by AuroMedics Pharma – New Recall Alert – May 8, 2018 – AuroMedics Pharma is voluntarily recalling two lots of Piperacillin and Tazobactam for Injection, USP 3.375 g (Piperacillin Sodium equivalent to 3 g of Piperacillin USP and Tazobactam Sodium equivalent to 0.375 g of Tazobactam USP. Each vial contains 7.05 mEq (162 mg) of Sodium) in a Single-Dose vial, to the hospital level. Read more.


    New Generic Launch

    No new updates.


    Clinical and Pharmacy News

    Software May Help Determine a Drug’s Cost Before it is Prescribed – May 8, 2018 – ‘How much does this cost,’ followed by, ‘My doctor said it would be [Insert free/cheaper response],’ is a conundrum faced many times throughout the week in the pharmacy. After all, in an era with changing formularies, rising drug costs and other issues plaguing the health system at large, predicting how much a drug will cost a patient is just one other item that is hard to address. Read more.

    Utilization Management Strategies Are Impacting Biosimilar Uptake, Says Report – May 8, 2018 – Avalere has issued a new report that finds that utilization management strategies, including preferential formulary design and step therapy, are impacting the uptake of biosimilars in the United States. While the Congressional Budget Office (CBO) in 2009 projected that the United States could achieve a $5.9 billion savings from biosimilars over 10 years, Avalere estimates the actual savings realized since the inception of the US biosimilars pathway at just $241 million, or 8 percent of the CBO’s projection for the period. Read more.

    Walmart to Limit Opioid Prescriptions at Pharmacies Amid Epidemic – May 7, 2018 – Walmart announced Monday the retail giant will begin to restrict opioid prescriptions to help stem the deadly drug epidemic. Walmart and Sam’s Club pharmacies are set to limit customers’ acute opioid prescriptions to a seven-day supply, with up to a 50 morphine milligram equivalent maximum per day, the company said in a news release. Read more.

    CMS Targets Value-Based Purchasing, Drug Costs to Reduce Spending – May 7, 2018 – Healthcare spending is growing at an unstainable rate, and CMS aims to curb spending through initiatives that promote value-based purchasing, reduce administrative burdens, and lower prescription drug costs, CMS Administrator Seema Verma told attendees at the American Hospital Association (AHA) Annual Membership Meeting. Read more.

    Independent Pharmacies Struggling Under New Medicaid Program – May 7, 2018 – Kamlesh Shah has seen a lot of ups and downs during his 28 years as a Chicago independent pharmacy owner. But the last few months have been unlike anything he’s experienced. “The way it is going … there is no way we can sustain our business,” said Shah, owner of B&K Drug, located inside a Humboldt Park medical clinic. Read more.

    Trump to Deliver Major Address on Drug Prices, but Advocates Predict Small Steps – May 4, 2018 – President Trump is preparing to deliver a long-awaited address on prescription drug prices as soon as next week, but advocates warn the White House may be focused more on populist messaging than swallowing bitter pills. Read more.

    To Enlist Physicians in Reducing Costs, Show Them the Costs – May 3, 2018 – In a recent speech, Alex Azar, the U.S. secretary of health and human services, said, “There is no more powerful force than an informed consumer.” What about an informed provider? If health systems are truly going to improve the value of the care they deliver, they need to enlist doctors in the effort. According to a national survey conducted by University of Utah Health, 89 percent of physicians believe the overall cost of healthcare in this country is too high. Read more.

    Cost of Cancer Drugs: Something Has to Give – May 3, 2018 – For a few patients with rare blood cancers that no longer respond to treatment, new therapies that genetically turbocharge their own immune cells may seem a lot like magic. The chimeric antigen receptor T cell (CAR-T) treatments that began earning FDA approvals last year put their disease on hold, perhaps indefinitely. For payers, though, CAR-T therapies may be a super-expensive headache. One from Novartis, for instance, is priced at $475,000, and the associated hospital care pushes the costs even higher. Read more.

    High BP Guideline Changes: Benefits and Harms – May 3, 2018 – The recent changes to the American College of Cardiology/American Heart Association high blood pressure (BP) guidelines have been controversial, with some groups claiming the new guidelines are not evidence based. An editorial published in JAMA Internal Medicine explained the decision process behind the change, the benefits and harms to patients and treatment recommendations under the new definitions. Read more.

    FDA Chief Questions Protections on Drug Rebates, Stocks Fall – May 3, 2018 – U.S. Food and Drug Administration Chief Scott Gottlieb on Thursday questioned whether rebates that drugmakers provide to health insurers should remain protected by federal law, sparking new concerns on Wall Street over efforts to curb drug pricing. Read more.

    Personalized Medicines May Be the Future of Healthcare – May 3, 2018 – When a person feels ill, his or her doctor may assess any symptoms and then prescribe a particular medication to treat or alleviate those symptoms. Doctors prescribe medications hoping to treat sickness, but sometimes prescriptions fall short, leaving some to wonder if prescription medications could be customized more for individual needs? The science is already here. Read more.

    White House Drug-Price Initiative to Include Negotiation Tools, List Prices, Azar Says – May 2, 2018 – HHS Secretary Alex Azar revealed Wednesday that the White House’s impending drug-pricing strategy will include strengthening the federal government’s ability to negotiate with drugmakers and address high list prices. Read more.

    Hormonal Contraceptive Prescribing by Pharmacists: A Brief Overview – May 1, 2018 – Pharmacists in all practice settings have opportunities to assist patients who use or seek to use contraception. In community pharmacies, pharmacists have the important role of providing the patient with the necessary information on how to safely, and effectively use their contraceptive method. This involvement may begin during pharmacy visits to obtain OTC methods, such as condoms or emergency contraception or conversations about contraceptive methods, as the patient explores their possible options. Read more.

    Fentanyl and Other Synthetic Opioids Contributed to More Overdose Deaths in 2016 than Prescription Painkillers – May 1, 2018 – Synthetic opioids, particularly illicit fentanyl, contributed to more overdose deaths in the United States in 2016 than prescription opioids, according to a new analysis. Synthetic opioids, a category distinct from heroin and prescription drugs like Vicodin or OxyContin, were listed as contributing to 19,413 deaths in 2016, 2,000 more than were connected to prescription opioids, according to an analysis published Tuesday in JAMA Psychiatry. Read more.


    340B in the News

    HHS Seeks 1-Year Delay on 340B Price Regulation: 4 Things to Know – May 7, 2018 – HHS released a proposed rule May 4 to delay a regulation that prevents drug companies from overcharging hospitals under the 340B Drug Discount Program. Here are four things to know. Read more.

    Point of View: Fixing Drug Discount Program Would Boost Rural Health Care – May 5, 2018 – For a state like Oklahoma, improving citizens’ access to affordable healthcare and medicine is a critical priority. With approximately one-third of Sooners residing in rural areas, and a large number living on tribal lands, the state needs strong rural health clinics and Federally Qualified Health Centers (FQHCs) to care for its residents. Read more.

    Judges Mull Reviving Hospitals’ Challenge to 340B Medicare Cuts – May 4, 2018 – A panel of federal appellate judges on Friday considered reviving the American Hospital Association’s challenge to Medicare 340B reimbursement cuts, questioning whether the changes were made properly. Read more.

    HRSA Issues Fifth Delay to Final Rule on 340B – May 4, 2018 – The Health Resources and Services Administration (HRSA) announced Friday it would delay the implementation of a final rule on the 340B Drug Pricing Program until July 2019, the fifth delay for the federal program. Read more.

    Will CMS Drive Further Changes to 340B? – May 2, 2018 – There are now multiple proposals in the House and Senate for substantive changes to the 340B Drug Discount Program. The odds of a legislative “fix” to 340B are increasing. But independent of congressional action, is CMS signaling that additional changes to 340B may be coming? Read more.