Clinical Insights: May 23, 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

    Doptelet® (avatrombopag) – May 21, 2018 – The Food and Drug Administration approved avatrombopag (Doptelet®, AkaRx Inc.) for thrombocytopenia in adults with chronic liver disease scheduled to undergo a procedure. Read more.

    LokelmaTM (sodium zirconium cyclosilicate) – May 18, 2018 – AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has approved LokelmaTM (sodium zirconium cyclosilicate), formerly ZS-9, for the treatment of hyperkalemia in adults. Read more.

    AimovigTM (erenumab-aooe) – May 17, 2018 – The U.S. Food and Drug Administration approved AimovigTM (erenumab-aooe) for the preventive treatment of migraine in adults. The treatment is given by once-monthly self-injections. AimovigTMis the first FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide, a molecule that is involved in migraine attacks. Read more.

    LucemyraTM (lofexidine hydrochloride) – May 16, 2018 – The U.S. Food and Drug Administration approved LucemyraTM (lofexidine hydrochloride) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults. While LucemyraTM may lessen the severity of withdrawal symptoms, it may not completely prevent them and is only approved for treatment for up to 14 days. LucemyraTM is not a treatment for opioid use disorder (OUD), but can be used as part of a broader, long-term treatment plan for managing OUD. Read more.


    New Formulation Approval

    No new updates.


    New Indication Approval

    Prolia® (Denosumab) – May 21, 2018 – Amgen announced that the U.S. Food and Drug Administration (FDA) has approved the use of Prolia® (denosumab) for the treatment of glucocorticoid-induced osteoporosis (GIOP) in men and women at high risk of fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. Read more.

    Arnuity® Ellipta® (fluticasone furoate) – May 21, 2018 – GSK announced it has received approval from the U.S. Food and Drug Administration (FDA) for the use of Arnuity® Ellipta® (fluticasone furoate) a once-daily inhaled corticosteroid (ICS) medicine for the maintenance treatment of asthma in children from as young as five years. Read more.


    New Drug Shortage

    May 22, 2018 

    May 21, 2018 


    New Drug Recall and Safety Alerts

    Juluca, Tivicay, Triumeq (dolutegravir) – New Safety Alert – May 18, 2018 – FDA to Evaluate – Potential Risk of Neural Tube Birth Defects. Serious cases of neural tube birth defects involving the brain, spine and spinal cord have been reported in babies born to women treated with dolutegravir used to treat human immunodeficiency virus (HIV). Read more.


    New Generic Launch

    Colesevelam HCI (Welchol®) – New First Time Generic – May 17, 2018 – Amneal Pharmaceuticals, Inc., a specialty pharmaceutical company, announced it has received final U.S. Food and Drug Administration (FDA) approval on its Abbreviated New Drug Application for a generic version of Welchol®(colesevelam HCI) tablets, 625 mg. Amneal has immediately initiated commercialization activities for this first-to-market opportunity.Read more.

    Phytonadione (Mephyton®) – New First Time Generic – May 15, 2018 – Amneal Pharmaceuticals, Inc. has launched Phytonadione Tablets, USP, 5 mg, the first AB-rated therapeutic equivalent for Mephyton®. Read more.


    Clinical and Pharmacy News

    FDA Warns of Decreased Survival in Some Patients Treated with Keytruda, Tecentriq Monotherapy – May 22, 2018 – Officials with the FDA are warning about decreased survival associated with the use of cancer immunotherapies pembrolizumab (Keytruda) and atezolizumab (Tecentriq) in ongoing clinical trials, according to a safety announcement. The use of these 2 treatments as a monotherapy in clinical trials have been associated with decreased efficacy in clinical trials among patients with metastatic urothelial cancer who have not received prior therapy and who have low expression of the protein programmed death ligand 1 (PD-L1), according to the FDA. Read more.

    Nonprofit Consortium Plans to Create Competition to Drive Down Drug Prices – May 21, 2018 – Nonprofits are becoming more and more involved in prescription drug pricing, specifically in creating alternative sourcing and distribution networks. We addressed this plan earlier in the year. Recently, the plan’s creators used the New England Journal of Medicine to lay out some strategy points we think are worthy of attention, particularly the use of competition to drive prices down. Read more.

    Clinician Org Says Trump Drug Price Plan Harms Patient Care Access – May 21, 2018 – Physicians are harboring concerns that the Trump Administration’s recently-announced plans to revamp prescription drug pricing will harm patient care access, increase patient costs, and reduce overall care quality, according to a survey conducted by the Community Oncology Alliance (COA). Read more.

    Worsening Drug Shortages Leave Providers Scrambling for Alternatives – May 21, 2018 – Dr. James Augustine receives a daily report that shows which drugs are in short supply. Last week, 115 emergency medications were unavailable. Read more.

    Part D Plan Sponsors Face Compliance Action on Drug Gag Orders, CMS Warns – May 18, 2018 – Medicare Part D plan sponsors that fail to ensure beneficiaries are paying the cheapest price for their drugs could face compliance action, the Centers for Medicare and Medicaid Services has said in a letter sent out Friday. CMS Administrator Seema Verma sent the letter to all Medicare Part D plan sponsors in reference to the practice of gag clauses in contracts that prevent pharmacists from telling patients the most inexpensive way to pay for drugs. Read more.

    FDA Names Drugmakers Potentially Acting to Delay Cheap Generics – May 17, 2018 – The U.S. Food and Drug Administration on Thursday listed a number of drugmakers it said could be improperly blocking access to their medicines in order to delay generic competition. Read more.

    Trump Administration Drug Pricing Blueprint: Overview and Analysis – May 17, 2018 – The administration’s drug pricing blueprint combines proposals that are already under way with new initiatives that may or may not be adopted. Many of the more dramatic proposals would require federal rulemaking or even legislation to be implemented on a broad scale. Read more.

    Trending News Today: Breast Cancer Drug May Work Just as Well with Briefer Treatment – May 17, 2018 – A new study finds that treating breast cancer with the drug Herceptin may work just as well with a briefer treatment regimen and reduce adverse effects, NPR reported. In a study of more than 4,000 women, the study authors determined that women with early-stage HER2-positive breast cancer did just as well with six months of treatment with Herceptin as did women who received a 12-month treatment course. Read more.

    Shifting Vaccinations to the Pharmacy Lowers Healthcare Costs – May 17, 2018 – Pharmacies can administer a wide range of vaccines to patients at significantly lower healthcare costs than physician practices and other medical settings, a new report from the Pacific Research Institute found. Read more.

    Statement from FDA Commissioner Scott Gottlieb, M.D., On New Agency Efforts to Shine Light on Situations Where Drug Makers May be Pursuing Gaming Tactics to Delay Generic Competition – May 17, 2017 – No patients should be priced out of medicines they need to support their health. As stressed by the President and Secretary Azar last week, one of the Administration’s highest priorities is advancing policies that increase competition as a way to help make drugs more affordable and improve access. Read more.

    Many Drugs Could Come Equipped with Ingestible Sensors – May 16, 2018 – Proteus Digital Health recently announced a new pipeline of research using their bioingestible sensors. Now, if you are not familiar with Proteus Digital Health, you may at least have heard of one of their recent products that got FDA approval. Read more.

    Opioid Use in Chronic Low Back Pain: A Population Study – May 16, 2018 – The most common prescription drug in U.S. adults with chronic low back pain (LBP) are opioids, according to a population study based on the 2009 to 2010 National Health and Nutrition Examination Survey and published in the Journal of Pain. Opioids in this population were found to be used long-term and in combination with other central nervous system-acting agents. Read more.

    The Winners and Losers Under Trump’s Plan to Combat High Drug Prices – May 16, 2018 – Last week, Donald Trump unveiled his blueprint to combat rising drug prices, called the “American Patients First” plan. The plan includes persuading other countries to pay more for prescription drugs, trying to lower drug prices for Medicare, more regulation around drug ads, banning the “gag clauses” for pharmacists, reining in patients and fixing the rebate system. Read more.

    CMS Highlights Drug Price Transparency Data Dashboards – May 16, 2018 – CMS has released redesigned drug price dashboards to provide information about manufacturer drug costs and advance the agency’s goals of promoting consumer price transparency. Read more.


    340B in the News

    Early 340B Hospitals Gave More Uncompensated Care than Later Participants – May 22, 2018 – Hospitals that joined the 340B Drug Pricing Program at its onset provided more uncompensated care and low-profit services to patients than those who joined in its later years, according to a new research letter published in JAMA from researchers at Vanderbilt University and the University of Chicago. Read more.

    In the Senate, the 340B Drug Pricing Program Finds More Backers than Detractors – May 18, 2018 – It is not an easy thing for a Ryan White clinic or community health center to serve the needs of all their clients who are living with or affected by HIV. In fact, in the current political climate where receiving level funding year after year is often the best-case scenario, providing the extensive amount of care required is often impossible. That most Ryan White clinics and community health centers have been able to survive and even expand during these lean budgetary times is remarkable. Read more.

    CMS Administrator Seema Verma Promotes Cuts to 340B Drug Payments – May 17, 2018 – The Centers for Medicare and Medicaid Services’ focus on lowering drug prices now includes the contentious 340B Drug Pricing Program. On Wednesday, CMS Administrator Seema Verma told the Pharmacy Quality Alliance that the agency’s change in the 340B payment rate to qualifying hospitals would save Medicare beneficiaries $320 million this year. Read more.

    HHS Solicits Comments on Possible 340B Program Changes to Reduce Drug Prices – May 17, 2018 – The Department of Health and Human Services (HHS) is soliciting comments from the public on the Administration’s proposals to reduce drug prices and is targeting the 340B Drug Pricing Program as an area of focus. The 340B program requires drug manufacturers to sell outpatient drugs at discounted rates to certain public and non-profit hospitals that treat high volumes of low-income patients or are located in rural areas and other safety net providers that receive federal grant funding. Read more.

    Hospital Leaders: Further Cuts to 340B Would be ‘Devastating’ – May 16, 2018 – As legislators continued to debate the future of the 340B Drug Discount Program on Wednesday, leaders at several major health systems in both urban and rural settings raised concerns over the serious risks they face if those savings sustain significant cuts. Read more.