Clinical Insights: May 16, 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

    Retacrit® (epoetin alfa-epbx) – New Biosimilar Drug Approval – May 15, 2018 – U.S. Food and Drug Administration approved Retacrit®(epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia caused by chronic kidney disease, chemotherapy or use of zidovudine in patients with HIV infection. Retacrit®is also approved for use before and after surgery to reduce the chance that red blood cell transfusions will be needed because of blood loss during surgery. Read more.

    Andexxa® (coagulation factor Xa (recombinant), inactivated-zhzo) – New Orphan Drug Approval – May 4, 2018 – Portola Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Andexxa®[coagulation factor Xa (recombinant), inactivated-zhzo], the first and only antidote indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. Read more.


    New Formulation Approval

    No new updates.


    New Indication Approval

    Truvada® (Emtricitabine and Tenofovir Disoproxil Fumarate) – New Expanded Indication Approval – May 15, 2018 – Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved once-daily oral Truvada®(emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)—in combination with safer sex practices—to reduce the risk of sexually acquired HIV-1 in at-risk adolescents. Read more.

    Actemra® (tocilizumab) – New Expanded Indication Approval – May 14, 2018 – Genentech announced that the U.S. Food and Drug Administration (FDA) has approved the subcutaneous (SC) formulation of Actemra®(tocilizumab) for the treatment of active polyarticular juvenile idiopathic arthritis (PJIA) in patients two years of age and older. Read more.

    Gilenya® (fingolimod) – New Expanded Indication Approval – May 11, 2018 – Novartis announced that the U.S. Food and Drug Administration (FDA) has approved Gilenya®(fingolimod) for the treatment of children and adolescents 10 to less than 18 years of age with relapsing forms of multiple sclerosis, making it the first disease-modifying therapy indicated for these patients. Read more.

    Myrbetriq® (mirabegron) – New Indication Approval – May 7, 2018 – Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for the use of mirabegron in combination with the muscarinic antagonist solifenacin succinate for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency. Read more.


    New Drug Shortage

    May 15, 2018 

    May 14, 2018 

    May 10, 2018 

    May 9, 2018 


    New Drug Recall and Safety Alerts

    Ampicillin and Sulbactam for Injection by AuroMedics Pharma – New Recall Alert – May 8, 2018 – AuroMedics Pharma is voluntarily recalling two lots of Ampicillin and Sulbactam for Injection USP, 3 g/Single-Dose vials, to the hospital/user level. The recall has been initiated due to customer complaints of the presence of red particulate matter in the product that is believed to be red rubber particles from the manufacturing process of the active ingredients. Read more.


    New Generic Launch

    No new updates.


    Clinical and Pharmacy News

    ‘Patent Dance’ Creates Hurdles to Biosimilar Drug Launches – May 16, 2018 – In an unprecedented unanimous ruling on June 12, 2017, the Supreme Court ruled that biosimilar drug manufacturers applying for approval from the FDA “may provide notice of commercial marketing to the branded biologic drug manufacturer before obtaining a license.” This ruling was significant for all stakeholders in the healthcare space. From biologic and biosimilar drug manufacturers, to payers, providers, pharmacies and, most importantly, patients requiring these medications, this ruling will have a lasting impact. Read more.

    American Patients First: The Trump Administration’s Blueprint to Lower Drug Prices – May 15, 2018 – On Friday, May 11, 2018, President Trump delivered a highly anticipated speech addressing high drug prices and unveiling his administration’s blueprint to lower drug prices and reduce out-of-pocket costs. American Patients First: The Trump Administration blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs identifies four challenges in the American drug market. Read more.

    Payers Express Enthusiasm for Prescription Drug Pricing Reforms – May 15, 2018 – Healthcare payers and associated trade groups have expressed enthusiasm about President Trump’s proposed prescription drug pricing reforms. A number of influential organizations have offered commentary on the plan, including some of their own suggestions for how to best address the skyrocketing prices of prescription drugs. Read more.

    Why Hospitals Need to Adopt a ‘Retail Mindset’ When it Comes to Analytics – May 15, 2018 – With rising drug costs, value-based care, changes in reimbursement rules and more demanding consumers, there’s no shortage of things that can change in a year. That means hospital IT departments need to employ quicker, more agile analytics that enable them to pivot in response to fast-changing conditions. Read more.

    Wall Street’s Whispering that Trump May Take a Hammer to One of Healthcare’s Most Lucrative Businesses – May 11, 2018 – Wall Street thinks President Donald Trump could announce measures that will take a jackhammer to an incredibly profitable business in the healthcare industry, pharmacy benefit managers (PBMs). These little known companies manage lists for healthcare programs — that is to say they are the gatekeeper between you and the prescription drugs your program (public or private) allows you to buy. Read more.

    Statement from FDA Commissioner Scott Gottlieb, M.D., on the Trump Administration’s Plan to Lower Drug Prices – May 11, 2018 – Today is an important day in the Administration’s collaborative effort to address the rising cost of drugs. We know that the high list cost of drugs can adversely impact peoples’ access to medicines. People rely on medicines to improve their quality of life, manage chronic conditions and treat life-threatening illnesses. Read more.

    Trump’s Plan to Lower Drug Prices Includes Encouraging Biosimilar Competition – May 11, 2018 – This afternoon, President Donald Trump delivered a long-anticipated speech on reducing the price of drugs for American patients. Trump has long decried the high cost of drugs, and called reducing prices one of his “greatest priorities” in his 2018 State of the Union address. In today’s remarks, delivered from the White House’s Rose Garden, the President outlined the broad strokes of what he called “the most sweeping action in history to lower the price of prescription drugs for the American people.” Read more.

    How Data Analytics and Artificial Intelligence are Changing the Pharmaceutical Industry – May 10, 2018 – Whether your organization has already begun the necessary process of incorporating data analytics and artificial intelligence into pharmacy operations or it is undergoing a due diligence project to decide if it’s time to implement a pharmacy technology upgrade initiative, one thing is for sure: Data analytics and artificial intelligence will have a tremendous impact on how pharmacies operate, both today and well into the future. Read more.

    FDA Says Mylan’s EpiPen is in Shortage – May 10, 2018 – U.S. regulators said that Mylan NV’s EpiPen products are in shortage, due to manufacturing delays that are creating intermittent supply constraints of the emergency allergy treatment. Read more.

    Hospitals in U.S. Sound Alarm on Impending Chemotherapy Shortages – May 9, 2018 – Hospitals in the U.S. are warning of an impending shortage of life-extending chemotherapy drugs caused by manufacturing issues at large drugmakers. Two types of chemotherapy, known as vincristine and etoposide, are in short supply, according to several hospitals, as drugmakers including Pfizer and London-listed Hikma Pharmaceuticals struggle to meet demand. Read more.


    340B in the News

    DRUG DISCOUNT PROGRAM: Status of Agency Efforts to Improve 340B Program Oversight – May 15, 2018 – The “340B” program requires drug manufacturers to sell outpatient drugs to covered entities—certain hospitals and federal grantees (like health centers and clinics)—at a discount to have their drugs covered under Medicaid. This testimony describes the Health Resources & Services Administration’s oversight of the 340B Program. Read more.

    Senate Committee Turns 340B Spotlight on Drugmakers – May 15, 2018 – Lawmakers turned their sharp scrutiny of the 340B program on drugmakers Tuesday, questioning why states and providers don’t know the ceiling prices within the drug discount program. In a hearing Tuesday, members of the Senate health committee asked government watchdogs why the Trump administration has delayed for the fifth time a rule that would set ceiling prices and why 340B hospitals don’t know what they ought to be paying for the discounted drugs. Read more.

    340B Scrutinized in Senate, Targeted by Trump – May 15, 2018 – The Senate HELP Committee again turned its attention toward the 340B Drug Pricing Program on Tuesday, calling into question the program’s vague intent, lack of transparency surrounding its rules and “inadequate” level of oversight by the Health Resources and Services Administration. Read more.

    Physician Poll Finds USA’s 340B Program Being Inappropriately Used – May 15, 2018 – The USA-based non-profit Institute for Patient Access (IfPA) has released the results of a recent poll of physicians showing concern about the federal government’s 340B Drug Pricing Program, which was designed to encourage care for indigent and underinsured patients but has instead ballooned into a revenue stream for growing hospital systems. Read more.

    HHS Looks to Alter 340B Patient Definition, Regulatory Authority for Drug Pricing Initiative – May 14, 2018 – As HHS Secretary Alex Azar on Monday bludgeoned the pharmaceutical industry and promised that he would use his “very powerful pen” to upend Medicare Part B’s payment structure, the agency asked providers and pharmaceutical companies to weigh in on potential changes to the 340B Drug Discount Program. Read more.

    Letters: Cassidy Drug Bill Deserves Support – May 14, 2018 – Helping Louisiana’s citizens afford their prescription drugs is a critical issue and one step in that direction would be the passage of U.S. Sen. Bill Cassidy’s bill to reform the federal 340B Prescription Drug Discount Program. Read more.

    The 340B Ceiling Price and CMP Rule…Changes on the Horizon? – May 10, 2018 – After more than eight years in the making, the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation (the “Rule”) seems to be a rudderless ship on a shoreless sea. On Monday, the Health Resources and Services Administration (HRSA) issued a notice of proposed rulemaking delaying the implementation date of the final Rule from July 1, 2018 to July 1, 2019. Read more.

    HRSA Proposes Fifth Delay of 340B Drug Pricing, Penalty Rule – May 9, 2018 -The Health Resources and Service Administration (HRSA) recently proposed a one-year delay of a final rule that would implement 340B drug pricing rules and civil monetary penalties for drug manufacturers that intentionally overcharge hospitals. If finalized, the implementation date would be July 1, 2019. Read more.

    Another View – Steve Ahnen: Hospitals Use Drug Program to Improve Care – May 8, 2018 – The recent Union Leader column by Thomas E. Blonski titled “Vulnerable patients need Maggie Hassan’s HELP” calls into question the integrity of the 340B Prescription Drug Savings program, as well as the commitment of New Hampshire hospitals who serve our state’s most vulnerable and underserved citizens. Blonski clearly misses the mark in understanding how hospitals use the 340B program to serve patients. Read more.