Clinical Insights: April 3, 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

    SymfiTM (efavirenz, lamivudine and tenofovir disoproxil fumarate) – March 22, 2018 – Mylan N.V. announced that it will introduce in the U.S. a third cost-saving HIV combination. The U.S. Food and Drug Administration (FDA) approved Symfi™ (efavirenz, lamivudine and tenofovir disoproxil fumarate) 600 mg/300 mg/300 mg tablets, a once-daily, single-tablet regimen (STR), indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 40 kg. Read more.


    New Formulation Approval

    No new updates.


    New Indication Approval

    Blincyto® (blinatumomab) – New Drug Approval – March 29, 2018 – The Food and Drug Administration granted accelerated approval to blinatumomab (Blincyto, Amgen Inc.) for the treatment of adult and pediatric patients with B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. Read more.

    Tasigna® (nilotinib) – New Expanded Indication Approval – March 22, 2018 – Novartis announced that the U.S. Food and Drug Administration (FDA) expanded the indication for Tasigna® (nilotinib) to include treatment of first- and second-line pediatric patients one year of age or older with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP). Read more.


    New Drug Shortage

    March 28, 2018 

    March 27, 2018 

    March 26, 2018 

    March 23, 2018 



    New Drug Recall and Safety Alerts

    No new updates.


    New Generic Launch

    palonosetron HCl Injection (Aloxi®) – First-time Generic Launch – March 26, 2018 – Dr. Reddy’s Laboratories Ltd. announced launches of palonosetron HCI injection. Read more.

    palonosetron HCl Injection (Aloxi®) – First-time Generic Launch – March 26, 2018 – Cipla USA, Inc. announced launches of palonosetron HCI injection. Read more.

    palonosetron HCl Injection (Aloxi®) – First-time Generic Launch – March 23, 2018 – Teva Pharmaceutical Industries Ltd. also announced the launch of a generic version of Aloxi® (palonosetron HCI) injection, 0.25 mg/5 mL, in the United States. Palonosetron hydrochloride injection—in a class of medications called 5-HT3 receptor antagonists—is used in adults to prevent nausea and vomiting that may occur as a result of receiving cancer chemotherapy with a moderate or high risk of causing nausea and vomiting. Read more.


    Clinical and Pharmacy News

    CMS Consideration of Rebate Overhaul Elicits Strong Opinions Both Pro and Con – April 3, 2018 – Fear and hope are coursing through the pharmaceutical distribution chain as the Centers for Medicare and Medicaid Services (CMS) determines how far it wants to go in forcing pharmacy benefit managers (PBMs) and Part D insurers to give consumers some of the money those two sectors retain through rebates and direct and indirect remuneration (DIR) fees. Read more.

    Newer Specialty Drugs Require Payers to Revise Coverage Strategies – April 2, 2018 – The groundbreaking approval of 3 CAR T cell therapies in 2017 has not only opened up the possibility of cures for patients but also sent shockwaves through the payer community, which is responsible for a large chunk of the costs. The launch cost of hundreds of thousands of dollars plus spending on monitoring and hospitalization, it is clear that payers must revisit their traditional formulary approach. Read more.

    Walmart, Humana Reportedly in Early Merger Talks – March 30, 2018 – Walmart and health insurer Humana reportedly are in early discussions regarding a possible merger, the Wall Street Journal is reporting. A potential merger, if it went through, would bring the Bentonville, Ark.-based retailer even further into the healthcare space that it has pushed into with its pharmacies, Care Clinics, optical centers, lab testing services and Wellness Day events. Read more.

    Opposition to Looming Compounding Practice Changes – March 30, 2018 – Changes to federal and state legislation that expand oversight of common mixing and compounding practices in dermatology could a have substantial impact on doctors and their patients, according to Murad Alam, M.D., M.B.A., president elect of the American Society for Dermatologic Surgery and vice chair of dermatology at Northwestern University. Read more.

    Do DIR Fees Stand a Chance in 2018? – March 30, 2018 – Direct and indirect remuneration (DIR) fees were one of the most controversial topics in the pharmacy space in 2017, with many pharmacists calling on lawmakers to put a stop to these charges. DIR fees were first implemented by the Centers for Medicare and Medicaid Services (CMS) to account for manufacturer rebates; however, pharmacy benefit managers (PBMs) used DIR to justify charging pharmacies retroactive, opaque fees, according to a session presented on March 7 during the 2018 Fifteenth Annual MHA Business Summit. Read more.

    Pharmacists Help Drive Down Infection Rates – March 30, 2018 – Hospital-acquired infections (HAIs) continue to plague the nation’s hospitals. However, significant progress has been made in preventing many of the most common infections. Between 2008 and 2016 there has been a 50 percent decrease in central line-associated bloodstream infections (CLABSIs) as well as with other common HAIs, according to the latest data from the CDC. Read more.

    Blue Cross and Blue Shield Discourages Using Opioids as Primary Pain Treatment – March 29, 2018 – The Blue Cross and Blue Shield Association has adopted a new standard that opioids should not be the first or second treatment options to manage pain, mirroring guidelines set by the Centers for Disease Control and Prevention. In most cases, ibuprofen and acetaminophen can treat pain more effectively than opioids, said Dr. Trent Haywood, chief medical officer for the Blues association, which has about 106 million members. Read more.

    Aetna Announces Plans to Pass Along Drug Rebates to Consumers at Pharmacy Counter – March 29, 2018 – Aetna said that it will automatically apply pharmacy rebates for its commercial plan consumers at the time of sale starting in 2019. The announcement follows a similar release by UnitedHealthcare earlier this month. Both insurers aim to promote transparency, lower out-of-pocket costs and call attention to the high price of prescription drugs. Read more.

    Pharmacists and Annual Wellness Visits – March 29, 2018 – Medicare Part B provides for its members an annual wellness visit (AWV), given by a Medicare Part B–approved practitioner such as a physician, physician assistant, nurse practitioner and clinical nurse specialist or a medical professional, such as a pharmacist, who is working under the direct supervision of a physician. Read more.

    Rite Aid, Albertsons Merger Gains Momentum with HSR Expiration – March 29, 2018 – Rite Aid Thursday morning announced that the HSR waiting period (under the Hart-Scott-Rodino Antitrust Improvements Act of 1976) in connection with its previously announced merger with Albertsons, expired this midnight past. Read more.

    What Pharmacists Should Know About Biologics, Biosimilars – March 29, 2018 – The changing pharma landscape with biologic drugs and the emergence of biosimilars presents unique opportunities for pharmacists, but also raises new challenges as time goes on, according to a session presented on March 7 during the 2018 Fifteenth annual MHA Business Summit. Read more.

    Uncovering Med Error Vulnerabilities: Pharmacy Practice News Report – March 28, 2018 – A recent survey found that medication errors are most likely to occur during care transitions. The Institute for Safe Medication Practices has issued new recommendations to encourage hospitals to improve their medication administration practices. Read more.

    Acute Pain Treatment in the ED: Consensus Guidelines – March 28, 2018 – In a white paper position statement prepared for the American Academy of Emergency Medicine and published in the Journal of Emergency Medicine, a panel of emergency medicine and pharmacology experts formulated guidelines for safely and effectively treating patients presenting to the emergency department (ED) with acute pain. Read more.

    Report Details Just How Amazon Could Disrupt Healthcare – March 27, 2018 – Amazon is entering healthcare — and healthcare may never be the same. That’s the takeaway from a new report by global management consulting firm L.E.K Consulting, which said the online giant has the right skills and capabilities to follow through on its big healthcare-industry ambitions and will launch offerings that range from mail-order pharmacy to AI-based diagnostics. Read more.

    Health Insurers, Big Pharma Play Blame Game Over Drug Prices – March 27, 2018 – Health insurers and pharmaceutical companies are pointing fingers at each other for the rising cost of prescription drugs as scrutiny over drug spending intensifies. Taking a tip from UnitedHealth Group, Aetna on Tuesday said it would pass on drug rebates to its fully insured commercial plan members at the pharmacy checkout counter. Read more.

    CDC Study Says Sinus Infections Are Treated with Antibiotics Longer Than Necessary – March 26, 2018 – A CDC study published in JAMA Internal Medicine on Monday found that primary care providers are prescribing antibiotics for sinus infections longer than recommended by clinical practice guidelines. A key antibiotic stewardship principle is to use the shortest effective length of antibiotics recommended by guidelines in order to fight the growing problem of antibiotic resistance. Read more.

    Tool Kit for Increasing Adherence to Antidepressants – March 26, 2018 – Depression, which affects 17 percent of Americans, is remarkably responsive to antidepressant therapy, but only if the patient actually takes the medication. Many patients are reluctant to take antidepressants, creating very high rates of nonadherence. Failure to adhere to antidepressant therapy leads to some high-risk outcomes. Read more.

    Prices for Widely Prescribed Medicare Part D Drugs Rose 12 Percent Annually, But Mind the Caveat – March 26, 2018 – The latest report to chronicle the rising cost of prescription medicines comes from a U.S. Senate committee that found prices for the 20 drugs most widely prescribed through Medicare Part D in 2015, on average, increased 12 percent each year between 2012 and 2017. Read more.

    The Role of Proton Pump Inhibitors for GI Bleed Prophylaxis in Patients on Dual Antiplatelet Therapy – March 26, 2018 – As the role and utilization of dual antiplatelet therapy (DAPT) increases, the rate of gastrointestinal (GI) bleeding events are also expected to rise. Gastrointestinal bleeds in patients with coronary artery disease (CAD) are associated with poor prognosis. The need to reduce and prevent these bleeding events is potentially mitigated by the use of proton pump inhibitors (PPIs). Read more.

    The Role of Adjunctive Corticosteroids in Community Acquired Pneumonia – March 25, 2018 – Optimizing the management of community-acquired pneumonia (CAP) still remains a goal of organizations like the Infectious Diseases Society of America (IDSA) and the American Thoracic Society (ATS). This is primarily due to the fact that CAP is common and has been associated with a significant amount of morbidity and mortality. Pneumonia is a leading cause of hospital admissions and healthcare resource consumption worldwide. Read more.

    NCCN Refines MM Treatment Guidelines – March 25, 2018 – The National Comprehensive Cancer Network (NCCN) has designated preferred treatment regimens for multiple myeloma, giving clinicians more specific guidance for managing these patients. Read more.

    Can Retail Pharmacies Come to the Aid of U.S. Healthcare? – March 23, 2018 – America’s healthcare system has been on the examining table lately: from the torturous battle over the Affordable Care Act, to Senator Bernie Sanders’ bill to allow low-cost prescription drugs in from Canada, to the intriguing announcement in January that Amazon, Berkshire Hathaway and JPMorgan Chase would create an independent healthcare company for their employees. Read more.


    340B in the News

    Congressman McKinley Recognized for Legislation to Help Rural Hospitals – April 2, 2018 – Congressman David McKinley (R-WV) is being recognized for his efforts to protect rural hospitals. He recently received the America’s Essential Hospitals Congressional Leadership Award for his work to reverse a Centers for Medicare and Medicaid Services (CMS) rule cutting $1.6 billion for drugs purchased under the 340B program. Read more.

    Hospitals Fight to Keep Drug Discount – April 1, 2018 – On top of an expected increase in uninsured patients, proposed cuts to a drug discount program would further threaten their bottom line, local hospital officials say. “The change that was proposed … I think was somewhere between $3 million and $4 million (impact) on St. Luke’s,” said John Strange, CEO of St. Luke’s hospital. Read more.

    California Hospitals Try to Block Proposal to Ban Medicaid Providers From 340B – March 30, 2018 – A 340B battle is brewing in California, where Medicaid providers may get banned from using the federal drug discount program if the governor’s budget proposal moves forward. Read more.

    340B Drug Update: Good News for Some in the Program – March 29, 2018 – For one health system, staying the 340B drug program makes financial sense. Working at a large teaching hospital in Pennsylvania recently, I was able to ask the system CFO if he was thinking of giving up on the 340B program in light of the cuts. I was surprised by his answer. He said despite the changes, they were getting over $10 million in benefit from staying in the program in the upcoming year. Read more.

    Fix 340B Drug Discount Program to Increase Patient Access to Treatment – March 29, 2018 – As Americans continue to face a changing healthcare environment, much of the focus remains on legislative and executive actions around insurance reforms. But as costs continue to rise, two factors have largely escaped public criticism — hospital consolidation and abuses of the 340B drug discount program. Read more.

    HHS Seeks Another Delay For 340B Changes – March 28, 2018 – HHS has made its fifth request to delay a rule that would set new drug ceiling prices in the 340B drug discount program. The rule was supposed to kick in July 1. Read more.

    Letter: People Benefit from 340B Drug Program – March 27, 2018 – The soaring cost of prescription drugs threatens access to life-saving medications for millions of people across the country and thousands of Hoosiers here at home. For these vulnerable patients, safety net healthcare providers — supported by the 340B Drug Pricing Program — make all the difference. Read more.

    Opinion: 340B Reform a Step in the Right Direction for Cancer Patients – March 26, 2018 – We never imagined that a little-known federal program would come to have such a big impact on our nation’s cancer care system. Known as 340B, this well-intentioned program extends large discounts on prescription drugs to certain hospitals and clinics that treat high numbers of uninsured, poor or vulnerable patients. But good ideas don’t always go as planned. Read more.

    Despite Controversial 340B Payment Cuts, Study Suggests 85 Percent of Hospitals Will See Payment Increases – March 26, 2018 – As a result of the Medicare Outpatient Prospective Payment System (OPPS) rule that took effect on January 1, 85 percent of 340B hospitals will see net payment increases in 2018, with rural hospitals reaping the largest benefits, according to an analysis conducted by Avalere Health that was commissioned by Community Oncology Alliance (COA). Read more.