Clinical Insights: October 10, 2017

    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

    Zilretta™ (triamcinolone acetonide extended-release) – October 6, 2017 – Flexion Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) approved Zilretta™ (triamcinolone acetonide extended-release injectable suspension), the first and only extended-release, intra-articular injection for osteoarthritis knee pain. Zilretta™ is a non-opioid medicine that employs Flexion’s proprietary microsphere technology to provide proven pain relief over 12 weeks. Read more. 

    Ascor® (ascorbic acid injection) – October 3, 2017 – McGuff Pharmaceuticals Inc., announced the United States Food and Drug Administration’s New Drug Approval (NDA) of Ascor® (Ascorbic Acid Injection, USP) is provided in a 50 mL vial labeled as a Pharmacy Bulk Package with a strength of 500mg/mL. Read more.

    Fiasp® (insulin aspart) – September 29, 2017 – Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) approved Fiasp® (insulin aspart injection) 100 Units/mL, a fast-acting mealtime insulin indicated to improve glycemic control in adults with type 1 and type 2 diabetes. Fiasp® can be dosed at the beginning of a meal or within 20 minutes after starting a meal. Fiasp® is a new formulation of NovoLog®, in which the addition of niacinamide (vitamin B3) helps to increase the speed of the initial insulin absorption, resulting in an onset of appearance in the blood in approximately 2.5 minutes. Read more.


    New Formulation Approval

    No new updates.


    New Indication Approval

    Botox® Cosmetic (onabotulinumtoxinA) – October 3, 2017 – Allergan plc announced the FDA approval of Botox® Cosmetic for its third indication, the temporary improvement in the appearance of moderate to severe forehead lines associated with frontalis muscle activity in adults. This approval makes the brand the first and only neurotoxin indicated for three facial treatment areas – forehead lines, crow’s feet lines and glabellar lines. Read more.


    New Drug Shortage

    October 6, 2017

    October 5, 2017


    New Drug Recall and Safety Alerts

    Intralipid 20 Percent IV Fat Emulsion by Baxter – New Drug Recall Alert – October 6, 2017 – Baxter International Inc. announced it is voluntarily recalling one shipment from a single lot of INTRALIPID 20% IV Fat Emulsion, 100 mL, distributed between 8/11/17 and 8/31/17 to hospitals and healthcare providers in the United States, to the user level. The product has been exposed to subfreezing temperatures during transit to a distribution facility. Read more.

    Intraocular Injections of a Compounded Triamcinolone, Moxifloxacin, and Vancomycin (TMV) Formulation – New Drug Safety Alert – October 3, 2017 – FDA received an adverse event report on August 14, 2017, from a physician concerning a patient who was diagnosed postoperatively with bilateral hemorrhagic occlusive retinal vasculitis (HORV) after being administered injections of a compounded triamcinolone, moxifloxacin, and vancomycin (TMV) formulation in each eye at the conclusion of cataract surgery procedures that were done two weeks apart. Read more.


    New First Time Generic

    Glatiramer Acetate (Copaxone®) – October 3, 2017 – Mylan N.V., announced that the U.S. Food and Drug Administration (FDA) has approved Mylan’s Abbreviated New Drug Applications (ANDAs) for Glatiramer Acetate Injection 40 mg/mL for 3-times-a-week injection, an AP-rated, substitutable generic version of Teva’s Copaxone® 40 mg/mL, and Glatiramer Acetate Injection 20 mg/mL for once-daily injection, an AP-rated, substitutable generic version of Teva’s Copaxone® 20 mg/mL, which are indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS), a chronic inflammatory disease of the central nervous system. Mylan will begin shipping imminently. Read more.


    Clinical and Pharmacy News

    Reported Penicillin Allergy Appears to Increase the Risk of Surgical Site Infections – October 9, 2017 – Investigators found that surgical patients believed to be allergic to penicillin were significantly more likely to develop surgical site infections than were patients with no documented allergy, a difference totally attributable to the alternative antibiotics used to prevent such infections. Read more. 

    Amazon Will Make Decision on Online Drug Sales by Thanksgiving, Report Says – October 9, 2017 – Web giant Amazon could be prepping to move into the multibillion-dollar prescription drug market just two months after digging deeper into the grocery market with its acquisition of Whole Foods. The company will make a decision before Thanksgiving, according to an email and an inside source cited by CNBC on Friday. If Amazon moves into selling prescription drugs online, it will work to bulk up its senior team with drug supply chain experts. Read more.

    People on HIV Medication Cannot Transmit the Virus, Declares CDC – October 9, 2017 – The Center for Disease Control (CDC) has declared that HIV-positive people taking effective medication to suppress the virus cannot pass it on through sex, and that it will update its guidelines accordingly. The landmark step by the U.S. public health institute follows years of clinical trials showing that those using effective anti-retroviral therapy (ART) do not risk infecting their sexual partners. Read more. 

    Pressure Mounts to Lift FDA Restrictions on Off-Label Drugs – October 8, 2017 – When the Food and Drug Administration gives its okay for a new drug to be sold, it specifies the diseases or conditions for which the medicine has been approved. That does not mean doctors can’t prescribe that drug for other ailments. They do. All the time. And it’s perfectly legal. But for decades drugmakers have been barred from promoting their drugs for uses that hadn’t gone through clinical trials. Worried about safety issues, the FDA has prosecuted numerous drugmakers for illegal promotion of off-label uses and extracted billions of dollars in fines and settlements. Read more.

    FDA Awards 15 Grants for Clinical Trials to Stimulate Product Development for Rare Diseases – October 6, 2017 – The U.S. Food and Drug Administration announced that it has awarded 15 new clinical trial research grants totaling more than $22 million over the next four years to boost the development of products for patients with rare diseases. These new grants were awarded to principal investigators from academia and industry across the country. Read more.

    Amazon’s Getting into The Pharmacy Business Is A ‘Matter of When, Not If’ – October 6, 2017 – Whether online retailer Amazon plans to enter the pharmacy-services space has been the subject of speculation for months, and Leerink analyst David Larsen is now going public with his position on the will-it-or-won’t-it question. Read more.

    Looming Biosimilars May Impact Top Selling Rheumatoid Arthritis Drug – October 6, 2017 – The QuintilesIMS Institute released data on the use of and spending on medicines in the United States for 2016, including multiple data on specific drug markets and an outlook toward 2021. The report included the top medicines based on invoice spending, a list led by rheumatoid arthritis (RA) treatment adalimumab (Humira, AbbVie) with $13.6 billion in spending in 2016. With this, adalimumab extended its reign atop the list to five consecutive years. Spending for the drug has tripled from 2012, increased from $4.5 billion. Read more.

    The FDA Is Approving Drugs at a Staggering Pace – October 6, 2017 – Gridlock under the Trump administration, particularly the repeated failures to repeal and replace Obamacare, is riveting the nation’s attention. Yet at least one government agency is running smoothly – and even accelerating its operations. The U.S. Food and Drug Administration, under Commissioner Scott Gottlieb, is taking advantage of policy groundwork laid in past years to speed drug approvals. Thirty-four new drugs – treating everything from cancer to rare genetic diseases – have been approved so far this year. Read more.

    Patients Want to Interact with Their Pharmacists on Social Media – October 4, 2017 – Social media has become a crucial tool for organizations and businesses to interact with their customers and discuss the services they offer. Many Americans look to social media for recommendations and to build stronger relationships with the brands they use. The results of the 2017 Pharmacy Social Media Survey—conducted by Propellar Insights on behalf of PrescribeWellness—indicate that Americans want to interact with their pharmacies on social media. Read more.

    Medicaid Drug Pricing Rule May Inhibit Value-Based Contracts – October 4, 2017 – A Medicaid drug pricing rule which safeguards deep discounts for the public program can potentially inhibit value-based contracts agreements between payers and pharmaceutical companies, according to research from the Journal of Health Politics, Policy and Law. Under the best-price rule, Medicaid is legally entitled to a minimum rebate of 23.1 percent for a manufacturer’s price for FDA-approved new drugs. The program is entitled to even lower prices if a drug manufacturer offered extended discounts to another payer or organization. Read more.

    PBM: Specialty Medications Drive Increased US Prescription Drug Spending – October 4, 2017 – The number of people who had annual prescription medication costs of $50,000 or more in 2016 was 35 percent higher than it was in 2014, according to pharmacy benefit manager (PBM) Express Scripts. The company’s new report, Super Spending: U.S. Trends in High-Cost Medication Use, indicates that nearly 0.3 percent of Express Scripts members had annual medication costs at or greater than $50,000 in 2016. While 0.3 percent seems like a very small population, the company notes, it accounted for 21.3 percent of total pharmacy costs. Read more.

    Hepatitis C Drug’s Lower Cost Paves Way for Medicaid, Prisons to Expand Treatment – October 3, 2017 – Valerie Green is still waiting to be cured. The Delaware resident was diagnosed with hepatitis C more than two years ago, but she doesn’t qualify yet for the Medicaid program’s criteria for treatment with a new class of highly effective but pricey drugs. The recent approval of a less expensive drug that generally cures hepatitis C in just eight weeks may make it easier for more insurers and correctional facilities to expand treatment. The drug, Mavyret, is the first to be approved by the Food and Drug Administration that can cure all six genetic types of hepatitis C in about two months in patients who haven’t previously been treated. Read more.

    Updates and Tips for Pharmaceutical Waste Management – October 3, 2017 – Institutions across the country are faced with two key challenges related to pharmaceutical waste management: 1) the proper disposal of drugs, particularly if they are deemed hazardous, and 2) the safe and secure disposal of unused controlled substances—an effort that can contribute to the national goal of addressing the ongoing opioid epidemic. Read more.

    SCPC: New Study of Medicare “DIR” Fee Legislation Helps Demonstrate PBMs as Bad Actors Across Full Spectrum of Transactions – October 3, 2017 – The Senior Care Pharmacy Coalition (SCPC) praised a new study by the Wakely Consulting Group finding the elimination of “clawbacks” Medicare Part D Prescription Drug Plans (PDPs) impose after sale to unjustifiably reduce payments to pharmacies would save the federal government $3.4 billion over ten years. These “clawbacks” are technically known as “Direct and Indirect Remuneration” (DIR) fees. Read more.

    Chronic Pain Management in Patients With HIV: New Guidelines – October 3, 2017 – In new guidelines published in Clinical Infectious Diseases, the HIV Medicine Association of the Infectious Diseases Society of America recommends that people living with HIV be screened for pain and offered both nonpharmacologic and pharmacologic treatment options. Read more.

    Experts Offer Tips on Deprescribing To Manage Polypharmacy – October 3, 2017 – Ways for pharmacists to communicate with patients and the care team. Sooner or later, every hospital pharmacist is bound to pull up a medication list for a senior patient and stare agog at the polypharmacy. A study published in the April 2016 issue of JAMA Internal Medicine found that 35.8 percent of older adults take at least five prescription medications, and 67.1 percent take five or more medications or supplements of any kind, including OTC medications. Read more.

    Cancer and Weight Gain: CDC Links High BMI with 13 Fatal Types of Disease – October 3, 2017 – A new report from the U.S. Centers for Disease Control and Prevention (CDC) affirms what experts keep saying: Being overweight puts a person at significantly higher risk for cancer. A study published Tuesday in Vital Signs, a publication from the CDC and based on data from the 2014 United States Cancer Statistics, finds excess body fat increases the risk for at least 13 different types of cancer. Read more.


    340B in the News

    Why West Virginia needs 340B Drug Pricing Program – October 9, 2017 – Like many states, West Virginia faces many challenges in providing necessary healthcare for its residents. Over a third of state residents live in rural areas, which means hospitals may be far away and doctors few and far between. West Virginia has 371 Health Professional Shortage Areas (HPSAs), of which my own county, Monongalia, contributes six. Read more.

    HHS Proposal Would Hurt Health-Care Providers and Their Most Vulnerable Patients – October 5, 2017 – While Congress remains gridlocked on healthcare reform, a significant change is making its way through the regulatory process that could dramatically reduce affordable access to prescription therapies for some of the nation’s most vulnerable patients. Read more.

    Proposed Changes To 340B Program Would Hurt Nonprofit Hospital Margins, Moody’s Says – October 3, 2017 – The program has allowed hospitals of varying size to realize meaningful operating cash flow, Moody’s says. Hospitals will continue to pay more for inpatient drugs, though Moody’s predicts the pace will moderate due to pharmaceutical scrutiny. Pharmaceutical costs have outpaced hospital revenue, contributing to weaker operating margins, according to the Moody’s Investors Service report released Tuesday. Read more.

    Providers Pinched by Rising Drug Costs, Looming Policy Changes – October 3, 2017 – Not-for-profit and public hospitals are reining in their spending as they cope with rising drug prices and proposed cuts to the 340B program that threaten to batter their margins. The gap between growth in not-for-profit and public providers’ revenue and supply costs widened between 2015 and 2016, according to a report from Moody’s Investors Service. Total drug spending rose by 8.5 percent, which marks a slight decline in sharp spending spikes, but could trend higher if the CMS’ proposal to reduce outpatient drug reimbursement to 340B hospitals by about 30 percent comes to fruition. Read more. 

    HRSA Delays 340B CMP And Ceiling Price Rule to July 1, 2018 And Intends to Reopen Rulemaking – October 2, 2017 – Last week, the Health Resources and Services Administration (HRSA) issued a Final Rule delaying the effective date and the enforcement date of the 340B Drug Pricing Program Ceiling Price and Civil Monetary Penalties Rule (the “CMP and Ceiling Price Final Rule”) from October 1, 2017, until July 1, 2018. The Final Rule is effective immediately. Read more.

    No, Health Costs Aren’t Rising Because Of Drug Discount Programs – October 2, 2017 – Why would a group that claims to hate government waste want to tear down a small federal healthcare program that saves taxpayers money? We should first start by following the money. In The Hill, the group Citizens Against Government Waste tore into the tiny 340B drug discount program, claiming it’s a reason why healthcare costs are rising. That’s absurd. 340B saves hospitals that serve low-income and rural communities (plus other smaller safety-net health-care providers) around $6 billion a year on medicine. Read more.

    Modernize Drug Discount Program – October 2, 2017 – There are countless examples of good government gone wrong, and the 340B drug discount program may be another. Created in 1992, it states that if drug manufacturers participate in Medicaid, they are required to give discounts to safety-net healthcare providers that serve low-income or uninsured patients. Read more.