Clinical Insights: June 13, 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

    FulphilaTM (pegfilgrastim-jmdb) – New Biosimilar Drug Approval – June 4, 2018 – The U.S. Food and Drug Administration approved FulphilaTM (pegfilgrastim-jmdb) as the first biosimilar to Neulasta®(pegfilgrastim) to decrease the chance of infection as suggested by febrile neutropenia (fever, often with other signs of infection, associated with an abnormally low number of infection-fighting white blood cells), in patients with non-myeloid (non-bone marrow) cancer who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia. Read more.


    New Formulation Approval

    No new updates.


    New Indication Approval

    Keytruda® (pembrolizumab) – New Indication Approval – June 12, 2018 – The Food and Drug Administration approved pembrolizumab (Keytruda, Merck and Co. Inc.) for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. Read more.

    Venclexta® (venetoclax) – New Indication Approval – June 8, 2018 – The Food and Drug Administration granted regular approval to venetoclax (VENCLEXTA, AbbVie Inc. and Genentech Inc.) for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy. Read more.

    Rituxan® (rituximab) – New Indication Approval – June 7, 2018 – Genentech announced that the U.S. Food and Drug Administration (FDA) has approved Rituxan® (rituximab) for the treatment of adults with moderate to severe pemphigus vulgaris (PV), a rare, serious, potentially life-threatening condition characterized by progressive painful blistering of the skin and mucous membranes. Read more.

    Mircera® (Methoxy polyethylene glycol-epoetin beta) – New Expanded Indication Approval – June 7, 2018 – The Food and Drug Administration approved methoxy polyethylene glycol-epoetin beta (Mircera, Vifor Pharma Inc.) for the treatment of pediatric patients five to 17 years of age on hemodialysis who are converting from another ESA after their hemoglobin level was stabilized with an ESA. Read more.

    Alimta® (pemetrexed) – New Expanded Indication Approval – June 5, 2018 – Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has granted approval for a new indication for Alimta® (pemetrexed for injection) in combination with carboplatin and Keytruda® (pembrolizumab) for the initial treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), irrespective of PD-L1 expression status. Under the FDA’s accelerated approval regulations, this indication is approved based on tumor response rate and progression-free survival (PFS). Read more.


    New Drug Shortage

    June 12, 2018 

    June 11, 2018 

    June 6, 2018 

    June 5, 2018 


    New Drug Recall and Safety Alerts

    Naloxone Hydrochloride Cartridge Syringe System by Hospira – New Drug Recall Alert – June 4, 2018 – Hospira, Inc., a Pfizer company, is voluntarily recalling lots 72680LL and 76510LL of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system (NDC 0409-1782-69), to the hospital/institution level due to the potential presence of embedded and loose particulate matter on the syringe plunger. Read more.


    New Generic Launch

    No new updates.


    Clinical and Pharmacy News

    Trump Administration is Shutting Down Practice-Guidelines Clearinghouse for Doctors – June 13, 2018 – Diagnostic and treatment guidelines aren’t sexy, but they play a vital role in the practice of medicine. Physician societies, government agencies and others issue detailed recommendations for everything from who should receive cardiac stents to which antibiotics patients should get to avoid infections after knee surgery. Read more.

    Role of Pharmacists in Harm Reduction: Syringe/Needle Exchange – June 13, 2018 – Historically, harm reduction (public health initiatives to minimize injurious social and physical consequences of human behavior) has successfully contributed to declining rates of teen pregnancy and HIV. As a result of the persistent opioid epidemic, a current harm reduction initiative focuses on reducing adverse consequences in drug users. Read more.

    More Than a Third of American Adults Take Prescription Drugs that can Cause Depression: Study – June 12, 2018 – More than one-third of American adults may be using prescription medications that can potentially cause depression or increase the risk of suicide, according to a study published Tuesday in the Journal of the American Medical Association. Read more.

    Generic Competition Not a Cure-All for High Drug Prices – June 12, 2018 – Bringing more generic drugs to market is a critical component of lowering drug prices, but it is not a panacea, according to a new report. The U.S. Food and Drug Administration has looked to increase generic competition as the primary lever to stem sky high drug prices. While the agency has succeeded in doing so, there’s a ceiling on the ultimate impact of that plan, researchers from PricewaterhouseCoopers said. Read more.

    OIG: HIV Telemedicine Program Doesn’t Violate Anti-Kickback Laws – June 12, 2018 – A healthcare provider offering free telemedicine equipment to a county health clinic for use in HIV treatment and support services won’t be sanctioned under federal anti-kickback laws, according to the Health and Human Services Department’s Office of the Inspector General. Read more.

    CMS Offers Opioid Coverage, Health IT Guidance for Medicaid Plans – June 11, 2018 – CMS has issued new opioid coverage strategies and health IT guidance to help states improve opioid safety within Medicaid plans. The guidelines include advice for state programs about treating infants with neonatal abstinence syndrome (NAS) and how to use health IT tools to enhance treatment for opioid-related disorders. Read more.

    Panel: Independent Pharmacies Need Changes to PBM Relationship – June 9, 2018 – Change is needed to create a better working relationship between pharmacy benefit managers (PBMs) and independent pharmacies, according to a panel of experts at the American Pharmacy Purchasing Alliance (APPA) conference in Orlando, FL. The five professionals appeared to share a common sentiment that current PBM practices are hurting the business of independent pharmacy, as well as the patients they serve. Read more.

    Insurers Continue to Deny Coverage for Life-Saving Hepatitis C Drugs at High Rates – June 8, 2018 – More than half of patients with hepatitis C are denied coverage by private insurers for life-saving treatments, according to a new study published in Open Forum Infectious Diseases. The number of patients denied coverage from public insurance also remains high. Read more.

    Oncologist Org Fights Medicare Reimbursement Cut to Cancer Drugs – June 7, 2018 – A group representing over 5,000 independent, community-based oncologists is suing HHS over the implementation of a two percent sequester cut to Medicare reimbursement for Part B cancer drugs. The Community Oncology Alliance (COA) is arguing that the Medicare reimbursement reduction implemented in April 2013 and extended by the Bipartisan Budget Act of 2018 is unconstitutional. Read more.

    Stroke Survivors Could Gain the Most from New Blood Pressure Guidelines – June 6, 2018 – Treating high blood pressure in stroke survivors more aggressively, could cut deaths by one-third, according to new research in Journal of the American Heart Association, the Open Access Journal of the American Heart Association/American Stroke Association. Read more.

    New Mobile Health Program Offers Pharmacy Access Through a Kiosk – June 6, 2018 – Express Scripts is piloting an mHealth program in Arizona where consumers can get prescriptions filled and video-chat with a pharmacist through a kiosk. Read more.

    Co-Pay Tactic by Benefit Managers Credited with Cutting Prescription Drug Prices – June 6, 2018 – A recently adopted tactic by U.S. health plans to limit the financial assistance drugmakers provide directly to consumers for prescription medicines is taking a toll on drug prices, according to a new analysis released on Tuesday. Read more.

    Point-of-Care Testing: Coming to a Pharmacy Near You? Maybe – June 6, 2018 – Point-of-care testing (POCT; tests performed outside of the laboratory, wherever patients are) increase patients’ access to care and treatment. In two areas—influenza and streptococcal pharyngitis—POCT is available, but not used as often as it could be. Annually, individuals in the United States contract 9.2 to 60.8 million cases of influenza and 11,000 to 13,000 cases of group A streptococcal pharyngitis. And older Americans contract an unacceptable number of cases of group B streptococcal pharyngitis. Read more.

    Pharmacy Benefit Managers are not the Cause of High Prescription Drug Prices – June 6, 2018 – The press has found no shortage of villains for the high cost of prescription drugs today. While the pharmaceutical companies typically receive the lion’s share of the blame, of late the Pharmacy Benefit Managers have come under fire for their supposed role in high drug prices. Read more.

    Embracing Competition to Empower Biosimilars – June 5, 2018 – In 2017, there were 46 new novel drug innovations, including new treatments for cancers, Parkinson’s disease and serious skin infections. These innovations are essential for improving the quality of healthcare in the U.S. However, innovation is not sufficient. It is equally imperative to promote drug affordability through greater competition. Read more.

    Learning from IV Drug Shortages: Be Prepared and Proactive – June 5, 2018 – Drug shortages aren’t going away anytime soon, which is why it’s important for pharmacies to put preparedness plans in place ahead of future IV shortages, according to an interactive discussion held this week at the ASHP Summer Meeting and Exhibition in Denver, CO. Read more.

    U.S. Drug Prices Hit by Insurer Tactic Against Copay Assistance: Analysis – June 5, 2018 – A recently adopted tactic by U.S. health plans to limit the financial assistance drugmakers provide directly to consumers for prescription medicines is taking a toll on drug prices, according to a new analysis released on Tuesday. Real U.S. drug prices, including discounts and rebates, fell 5.6 percent in the first quarter of this year, compared to a 1.7 percent drop in the same period a year ago, according to Sector & Sovereign research analyst Richard Evans. Read more.

    Medicare Part D Drug Spending Spikes by 77 Percent – June 5, 2018 – Despite a decrease in the number of prescriptions for brand-name drugs going down, Part D spending and out-of-pocket costs both spiked up from 2011 to 2015, according to a new report from the Office of the Inspector General. The total reimbursement for all brand-name drugs in Part D rose by 77 percent from 2011 to 2015 even though there was a 17-percent drop in prescriptions for those drugs. Even after taking into account manufacturer rebates, reimbursement for Part D brand-name drugs still swelled by 62 percent during that time period, the report said. Read more.

    There Might be a Cheaper Drug, But Pharmacists Can’t Tell You That – June 4, 2018 – A few months ago, Rhode Island state Rep. Brian Kennedy had a mild sinus infection, for which he was prescribed an antibiotic. That would be unremarkable, except for what happened next. Kennedy had a friend behind the pharmacy counter where he went to fill the prescription. The pharmacist-friend said he would charge Kennedy the retail price for the small drug dose he needed, without going through his insurance company, because the retail price was cheaper than the insurance copayment. Read more.

    Spending on Medicare Drugs Soars Despite Drop in Prescriptions – June 4, 2018 – Medicare paid 77 percent more for brand-name drugs over a five-year span, despite a 17 percent drop in the number of medicines prescribed, an inspector general study found. The study from the Department of Health and Human Services’ watchdog looked at the impact of high drug prices on costs for Medicare Part D, the program’s prescription drug plan. Read more.


    340B in the News

    Hospitals Urge Congress to Pass New 340B Legislation – June 12, 2018 – Hospitals on Tuesday urged Congress to pass a newly introduced bill to strengthen the 340B Drug Discount Program. Under the Stretching Entity Resources for Vulnerable (SERV) Communities Act introduced by Rep. Doris Matsui (D-Calif.), the HHS secretary must audit 340B providers and drug manufacturers. The bill also would force drug manufacturers to disclose drug pricing information publicly. Read more.

    340B Drug Pricing Program Final Rule Delayed…Again – June 12, 2018 – In a notice published on June 5, 2018, the Health Resources and Services Administration (HRSA) announced that the January 2017 340B Drug Pricing Program final rule (the “Final Rule”) will again be delayed. The Final Rule, which had an original intended implementation date of March 2017, is further delayed until July 1, 2019. Read more.

    340B Cuts Sting Struggling Hospitals, Hurt Credit Ratings, S&P Says – June 4, 2018 – Massive cuts to the 340B Drug Pricing Program could severely weaken, even cripple the already-struggling nonprofit hospitals who relied on savings gleaned from it, said a recent report from S&P Global Ratings. The $1.6 billion cut could weaken their operating performance, potentially leading to negative rating actions if hospital-specific funding cuts aren’t buffered by other management actions. Read more.