Clinical Insights: April 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

    No new updates.


    New Formulation Approval

    Afinitor Disperz® (everolimus) – New Formulation and Indication Approval – April 10, 2018 – On April 10, 2018, the Food and Drug Administration approved everolimus tablets for oral suspension (Afinitor Disperz®, Novartis Pharmaceuticals Corp.) for the adjunctive treatment of adult and pediatric patients aged two years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures. Read more.


    New Indication Approval

    Exparel® (bupivacaine liposome injectable suspension) – New Indication Approval – April 6, 2018 – Pacira Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) to broaden the use of Exparel® (bupivacaine liposome injectable suspension) to include administration via interscalene brachial plexus block to produce postsurgical regional analgesia. Read more.

    Rubraca® (rucaparib) – New Indication Approval – Apr. 6, 2018 – Clovis Oncology, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Rubraca® (rucaparib) tablets for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Read more.

    Emend™ (fosaprepitant) – New Expanded Indication Approval – April 3, 2018 – The FDA approval of Merck’s Emend (fosaprepitant) for injection in pediatric patients for the prevention of chemotherapy-induced nausea and vomiting in patients ages six months of age and older. Read more.

    Bydureon® (exenatide extended-release) – New Expanded Indication Approval – April 3, 2018 – AstraZeneca announced the U.S. Food and Drug Administration (FDA) has approved Bydureon® (exenatide extended-release) for injectable suspension as an add-on therapy to basal insulin in adults with type 2 diabetes (T2D) with inadequate glycemic control. Read more.


    New Drug Shortage

    April 11, 2018 

    April 10, 2018 

    April 6, 2018 

    April 4, 2018 

    April 3, 2018 


    New Drug Recall and Safety Alerts

    Sterile Injectable Products by Premier Pharmacy Labs – Drug Recall Alert – April 12, 2018 – Premier Pharmacy Labs is voluntarily recalling injectable products due to a potential lack of sterility assurance. Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products. Read more.

    Coastal Meds – All Products Marketed as Sterile – Drug Recall Alert – On April 5, 2018 – Coastal Meds initiated a voluntarily recall of all products intended to be sterile. FDA requested the compounder inform the public, but they have not done so. Therefore, FDA is alerting healthcare professionals to dispose of and not administer sterile drug products intended for injection that were produced and distributed by Coastal Meds. Read more.

    Kratom-containing Products by Triangle Pharmanaturals – Drug Recall Alert – April 3, 2018 – FDA issued a mandatory recall order for all food products containing powdered kratom manufactured, processed, packed or held by Triangle Pharmanaturals LLC, after several were found to contain salmonella. The agency took this action after the company failed to cooperate with the FDA’s request to conduct a voluntary recall. Read more.


    New Generic Launch

    No new updates.


    Clinical and Pharmacy News

    Drug Prices Are Too Expensive: Here’s How Technology Can Fix That – April 16, 2018 – The cost of drug development has skyrocketed, but disruptive technologies can bring it back down to earth. Over the past several decades, drug-development costs have risen significantly, from $250 million per approved drug prior to the 1990s to $403 million in the 2000s and $873 million in 2010 ($1.778 billion if capitalization over the 14-year approval period is accounted for). Read more.

    Prescription Drug Costs: Insurers Look to Pass Price Breaks Straight to The Consumer – April 14, 2018 – Some major health insurers plan to take a little sting out of prescription drug prices by giving customers rebates at the pharmacy counter. Aetna and UnitedHealthcare both say they will begin passing rebates they get from drugmakers along to some customers starting next year. Read more.

    U.S. Appeals Court Strikes Down Maryland Drug Price-Gouging Law – April 13, 2018 – A federal appeals court on Friday declared unconstitutional a 2017 Maryland law that lets the state attorney general sue generic drugmakers who sharply raise prices on medications. Read more.

    NACDS Tells House Committee how Pharmacy can Fight Opioid Abuse – April 13, 2018 – The House Energy and Commerce Committee has been looking into legislative solutions to the opioid crisis, and the National Association of Chain Drug Stores has highlighted pharmacy as a key player in curbing opioid abuse and misuse. Read more.

    Heparin-induced Thrombocytopenia: A Guide for Pharmacists – April 13, 2018 – Heparin-induced thrombocytopenia (HIT) is a complication of heparin therapy and is characterized by two types. HIT I is a benign, mild thrombocytopenia, which usually occurs within two days after heparin administration. Because the platelet count normalizes even with continued heparin therapy, it is not associated with increased thrombotic risk. Read more.

    Everything Pharmacists Need to Know About DIR Reform – April 13, 2018 – Direct and indirect remuneration (DIR) fees are the bane of many pharmacists’ lives. Now, changes may be coming. At last. “DIR fees have been disastrous for community pharmacy in part because of how much money they are clawing back, but just the uncertainty, the unpredictability of it is also a problem,” says Bradley J. Arthur, RPh, co-owner of two independent pharmacies in Buffalo, NY and past president of NCPA. Read more.

    As Cancer Drug Prices Climb, Value not Keeping Pace – April 12, 2018 – The cost of new anti-cancer drugs increased more than five-fold from 2006 to 2015, but a new analysis suggests that cancer patients and insurers may be getting less for their money. Read more.

    PBM Transparency, DIR Fees Top Priorities for Pharmacists on Capitol Hill – April 12, 2018 – The practices of pharmacy benefit managers (PBMs) and direct and indirect remuneration (DIR) fees continue to spark controversy in the pharmacy space, as many stakeholders are calling on lawmakers for more regulation. Read more.

    Odds of Prescribing Drugs Up with Receipt of Pharmaceutical Industry Payments – April 12, 2018 – Physicians receiving general payments from pharmaceutical companies are more likely to prescribe their drugs, according to a research letter published online April 9 in JAMA Internal Medicine. Read more.

    Costs Slashed When Prostate Cancer Drug Taken with Low-Fat Breakfast – April 11, 2018 – Prostate-cancer patients prescribed the drug abiraterone acetate are usually advised to take the drug on an empty stomach. A new study suggests, however, that following the advice causes patients to have to take higher dosages of the expensive drug and also are more likely to experience digestive issues. Read more.

    Telepharmacy Market is Projected to be Fueled by Rapid Technological Advancements – April 11, 2018 – There is no doubting the exponential surge of the telemedicine and telehealth market. The market is poised to expand at a significant rate in the next few years. Additionally, the advent of telepharmacy is expected to substantially impact the telemedicine and telehealth market in terms of enhancing its rural reach as well as worldwide penetration. Read more.

    ADA Updates Guidelines for Cardiovascular Risk Management in Diabetes – April 11, 2018 – The American Diabetes Association (ADA) has published its 2018 Clinical Standards of Medical Care guidelines focused on recommendations for the identification and management of cardiovascular (CV) risk factors in patients with diabetes. Read more.

    Why We May Lose Generic Drugs – April 11, 2018 – The mood at the annual generic drug industry confab in Orlando in February was especially somber. The discussion during one panel was all about plunging drug prices, consolidation among drug-buying groups, and the increasingly cutthroat nature of the business. Read more.

    Study: Despite Decline in Prescriptions, Opioid Deaths Skyrocketing due to Heroin and Synthetic Drugs – April 10, 2018 – Fatalities from heroin and black-market synthetic opioids skyrocketed while the nation saw a decline in the number of opioid painkiller prescriptions and the overdose deaths attributed to them, according to a study. Read more.

    AUA: New Guidelines for Diagnosis, Management of Testosterone Deficiency – April 10, 2018 – The American Urological Association (AUA) has issued new clinical guidelines on the diagnosis and management of testosterone deficiency. An expert panel was assembled to conduct a systematic review to provide an evidence-based document for the appropriate assessment and management of patients with testosterone deficiency. Read more.

    Payers Seize Opportunities to Control Diabetes Drug Costs – April 6, 2018 – Diabetes remains the top overall traditional drug spend category for commercial, Medicare D and Medicaid clients, according to the 2017 Drug Trend Report from Prime Therapeutics. Read more.

    How RA, Cancer, Hep C Drug Costs Will Change Over Next Five Years – April 6, 2018 – Inflammatory conditions took the lead in drug spending in 2017—a 15.3 percent increase over 2016—with $157.49 per person per year. Spending is expected to climb another 16 percent in 2018, 15 percent in 2019 and 14 percent in 2020, according to the Express Scripts 2017 Drug Trend Report. Read more.

    Adding a Pharmacist to the Home Health Team – April 5, 2018 – PPN’s David Bronstein talks with Amy A. Lemieux, PharmD, a staff pharmacist at Hallmark Health System, in the northern suburbs of Boston, about using home visits to help reduce 30-day readmissions. Read more.

    Point-of-Sale DIR Fees Addressed in New Medicare Part D Rule – April 5, 2018 – The Centers for Medicare and Medicaid Services (CMS) issued a final 2019 Medicare Part D rule on Monday addressing direct and indirect remuneration (DIR) fees. In the rule, CMS asserted its statutory authority to require that some portion of rebates and pharmacy DIR fees be applied at point of sale, according to a National Community Pharmacy Association (NCPA) press release. Read more.

    Is Telepharmacy Taking Pharmacy Jobs? – April 5, 2018 – Arizona is poised to become the 24th state to adopt telepharmacy legislation. The legislation is expected to be signed into law this year with the first outlets scheduled to open in early 2019. Read more.

    CDC Program Tries to Put Out Spark Before Resistance Spreads ‘Like Wildfire’ – April 3, 2018 – The CDC reported on bacteria with unusual antibiotic resistance genes that are widespread across the country, according to CDC Principal Deputy Director Anne Schuchat, MD, who discussed a new aggressive strategy to control the spread of these resistant organisms. Read more.

    CDC Report Highlights Current Trends in Opioid Prescriptions – April 3, 2018 – President Trump in late August declared that he considered opioids to be “a national emergency,” thereby increasing the intensity of an already bright spotlight on the current state of opioid prescriptions in the United States. While healthcare providers have been aware of the issues of overprescribed and inappropriately prescribed opioids, addiction potential and overdose risk, the general population may not have been—until recently. Read more.

    CMS Final Rule Aims to Lower Medicare Prescription Drug Costs – April 3, 2018 – CMS is planning to lower Medicare prescription drug costs through a final rule that allows members to purchase less expensive biosimilars and generic drugs and increases the potential value of Medicare Advantage (MA) and Part D plans. Read more.

    Walmart Reportedly Mulling Acquisition of Pharmacy Startup PillPack – April 3, 2018 – PillPack would help expand Walmart’s already extensive brick-and-mortar pharmacy operations and boost e-commerce through online prescription orders. The retail giant has been working hard to expand its digital storefront, mostly through acquisitions starting with the 2016 takeover of Read more.

    DEA Surge in Prescriber and Pharmacy Investigations Touted – April 3, 2018 – The U.S. Drug Enforcement Administration reports it is increasing the pressure on prescribers and pharmacies that it believes “dispensed disproportionately large amounts of controlled prescriptions.” Read more.


    340B in the News

    Recent 340B Program Developments – April 13, 2018 – Legal challenges to the significant Medicare reimbursement cuts for drugs purchased by most hospitals under the 340B program continue. As previously reported, the Centers for Medicare & Medicaid Services (CMS) issued a final rule effective January 1, 2018, cutting 340B-purchased drug reimbursement by nearly 27 percent for DSH hospitals. Read more.

    CMS Issues Updated Medicare Payment and Billing Policies for 340B Hospitals – April 12, 2018 – On April 2, 2018, CMS issued updated guidance related to the dramatic Medicare payment reductions that went into effect this year for certain 340B hospitals. The guidance explains the planned application of the payment cuts as they relate to Medicare Advantage (MA) plans, and it may have implications for how hospitals bill MA plans for 340B drugs given to out-of-network enrollees. Read more.

    HRSA Seeks Fifth Delay of Final Rule on 340B Pricing and Manufacturer CMPs; Budget Document Sheds Light on 340B User Fee and Other HRSA Priorities – April 10, 2018 – The 340B Drug Pricing Program (“340B Program”) remains in the regulatory spotlight. Most recently, on March 27, 2018, the Health Resources and Services Administration (“HRSA”) indicated it is poised to delay for the fifth time its final rule addressing drug pricing calculations and civil monetary penalties (“CMPs”) for manufacturers that knowingly and intentionally overcharge covered entities under the 340B Program. Read more.

    Our Rural Hospitals and Clinics are Under Attack – April 5, 2018 – Right now, policy developments in Washington, D.C. are placing rural North Dakota hospitals and other healthcare providers at significant risk of shutting down, choking off healthcare access for thousands of patients in rural communities who have few other options. In January, an agency in Washington, the Centers for Medicare and Medicaid Services, issued a troublesome ruling that will raise prices on prescription drugs for millions of Medicare beneficiaries who rely on the 340B drug program for reduced rates on medications (340B is simply the place in federal law that establishes this program). Read more.

    AHF Demands U.S. Rep. Scott Peters (D-CA) Name ‘Bad Actors’ Allegedly Abusing 340B Drug Program – April 3, 2018 – AIDS Healthcare Foundation (AHF) continues to sound the alarm that a nationwide drug discount pricing program vital to the country’s healthcare safety net – and its HIV/AIDS response – is once again under attack by the drug industry under the guise of ‘reform.’ Read more.