Clinical Insights: September 13, 2019

    Welcome to RxStrategies’ Clinical Insights, designed to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy market place. Contact us to learn more.


    New Drug Approval

    Ibsrela® (tenapanor) – New Drug Approval – September 12, 2019 Ardelyx, Inc., announced that the U.S. Food and Drug Administration has approved Ibsrela® (tenapanor), a 50 mg, twice daily oral pill for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults. Ibsrela® is a minimally-absorbed small molecule that acts locally in the gastrointestinal (GI) tract to inhibit the sodium-hydrogen exchanger NHE3, resulting in an increase in bowel movements and a decrease in abdominal pain for IBS-C patients. Read More>

    Gvoke™ (glucagon injection) – New Drug Approval – September 10, 2019 Xeris Pharmaceuticals, Inc., a specialty pharmaceutical company leveraging its novel technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, announced that it has received regulatory approval from the U.S. Food and Drug Administration (FDA) for Gvoke™ (glucagon) injection, its ready-to-use, room-temperature stable liquid glucagon for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes ages 2 years and above. Read More>

    New Formulation Approval

    Riomet® ER (metfiormin extended release oral suspension) – New Formulation Approval – August 29, 2019 The FDA approved Sun Pharmaceuticals new drug application (NDA) for Riomet® ER (metformin hydrochloride for extended-release oral suspension) as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. Read More>

    New Indication Approval

    Nucala®(mepolizumab) – New Indication Approval – September 12, 2019 GlaxoSmithKline announced that the US Food and Drug Administration (FDA) has approved Nucala® (mepolizumab) for use in children as young as six years old who are living with severe eosinophilic asthma. Nucala® is the only targeted biologic to be approved for the condition in the six to 11-year age group in the US. Read More>

     Ofev® (nintedanib) – New Orphan Indication Approval – September 6, 2019 The U.S. Food and Drug Administration approved Ofev® (nintedanib) capsules to slow the rate of decline in pulmonary function in adults with interstitial lung disease associated with systemic sclerosis or scleroderma, called SSc-ILD. It is the first FDA-approved treatment for this rare lung condition. Read More>

    Juvéderm Voluma® XC – New Indication Approval – September 3, 2019 Allergan plc announced it received U.S. Food and Drug Administration (FDA) approval for the use of Juvéderm Voluma® XC, a hyaluronic acid gel dermal filler, with a TSK Steriglide™ cannula for cheek augmentation to correct age-related volume deficit in the mid-face in adults over 21. Read More>

    New Drug Shortage

    September 13, 2019

    September 12, 2019

    September 11, 2019

    September 09, 2019

    September 03, 2019

    August 28, 2019

    New Drug Recall and Safety Alerts

    Milk of Magnesia Oral Suspension by Plastikon Healthcare – New Drug Recall – September 9, 2019 Lawrence, KS, Plastikon Healthcare, LLC is voluntarily recalling Milk of Magnesia 2400 mg/30 mL Oral Suspension, lots 19027D and 19027E, to the patient level. Plastikon Healthcare initiated this recall because these product lots did not meet Plastikon’s in-house microbiological specification for Total Aerobic Microbial Count. Read More>

     Bacteriostatic Water for Injection USP by Hospira – New Drug Recall – September 6, 2019 Hospira, Inc., a Pfizer company, is voluntarily recalling Bacteriostatic WATER for Injection, USP, 30 mL, multi-dose vial, lot W20308, to the Hospital/Retail level. Hospira initiated this recall due to lack of confirmation of sterilization for some vials from this lot. Read More>

     Bevacizumab – New Drug Recall – August 30, 2019 AmEx Pharmacy announced a voluntary recall of all Lots of Bevacizumab 1.25mg/0.05mL 31G Injectable and all Lots of Bevacizumab 2.5mg/0.1ml Normject TB Injectable that are within expiry to the healthcare provider level. These lots are being recalled out of an abundance of caution following an FDA inspection. Read More>

    Mavyret™ (glecaprevir/pibrentasvir), Zepatier® (elbasvir/grazoprevir), and Vosevi® (sofosbuvir/velpatasvir/voxilaprevir) – New Drug Safety Alert – August 28, 2019 The Food and Drug Administration (FDA) has received reports that the use of Mavyret™, Zepatier®, or Vosevi® to treat chronic hepatitis C in patients with moderate to severe liver impairment has resulted in rare cases of worsening liver function or liver failure. All these medicines contain a hepatitis C virus (HCV) protease inhibitor and are not indicated for use in patients with moderate to severe liver impairment. Read More>

    New Generic Approval and Launch

    NovoLog® and NovoLog® Mix– New Authorized Generic – September 6, 2019 Novo Nordisk announced it will be launching authorized generics, follow-on brand versions of NovoLog® and NovoLog® Mix. Which will be priced at a 50 percent discount compared to the current list price of the branded versions. NovoLog® is Novo Nordisk’s most widely prescribed insulin, used by approximately one million people with diabetes in the US. Read More>

    Clinical and Pharmacy News

    Senate Finance Committee Wants Trump Action on DIR Fees – September 12, 2019 Several pharmacy groups lauded a letter from the chairman and a majority of the Senate Finance Committee urging the Trump administration to reform direct and indirect remuneration (DIR) fees. Read More>

     Orphan Drugs Are Driving Skyrocketing Drug Costs, AHIP Find – September 12, 2019  The price of orphan drug medications is increasing at a far more rapid pace than that of other specialty and traditional drugs, according to a new report from America’s Health Insurance Plans (AHIP).The new study has shown that the average annual cost for orphan drugs is 25 times more expensive than traditional drugs. Orphan drugs have also been a key driver behind the sharp increase in annual drug costs at launch, which have grown from $9781 in 1998 to $106,149 in 2017. Read More>

    Pharmacy Groups Praise Senate Finance Committee Members’ Letter On DIR Fee Reform – September 12, 2019 Pharmacy organizations are celebrating a letter from members of the Senate Finance Committee calling for reform of direct and indirect remuneration, or DIR, fees. The chairman, ranking member, and an overwhelming majority of the Senate Finance Committee have asked the Trump Administration to do its part to close the Medicare regulation loophole that enables the fees to be assessed. Read More>

     States Pass Record Number Of Laws To Reel In Drug Prices – September 11, 2019 Whether Congress will act this year to address the affordability of prescription drugs — a high priority among voters — remains uncertain. But states aren’t waiting. So far this year, 33 states have enacted a record 51 laws to address drug prices, affordability and access. Read More>

    CDC Expands Age Indication for One Flu Vaccine, Changes Dosage for Another – September 11, 2019 The recommended use of two inactivated influenza vaccines has been changed for the upcoming flu season, according to public health officials. The CDC announced recent labeling changes for two IIV4s, Afluria Quadrivalent and Fluzone Quadrivalent. Based on discussions at three public meetings by the Advisory Committee on Immunization practices (ACIP), the age indication for Afluria Quadrivalent has been expanded from age 5 years or older to age 6 months or older. Read More>

     Report: Delayed Adoption Of Biosimilars Has Cost System $2.2B Since 2015 – September 11, 2019 The Biosimilars Council, a division of the Association for Accessible Medicines has released Part II of its white paper series, “Failure to Launch,” finding that anti-competitive rebating tactics by brand name manufacturers, coupled with policy failures and inadequate incentives for biosimilar use, stifle biosimilars adoption in the United States. This has resulted in nearly $2.2 billion in lost savings for America’s health care system and patients since 2015. Read More>

     Drug Prices Keep Rising Amid Political Pressure, But Not As Fast – September 10, 2019 Prices for the majority of drugs in the U.S. have started to rise more slowly, likely a result of public and political pressure, according to a five-year study released Tuesday by drug pricing startup GoodRx. Read More>

     The Evolving Role of Specialty Pharmacy – September 10, 2019 Specialty pharmacies have their roots in the 1970s, when they began delivering temperature-controlled drugs to treat cancer, infertility and hemophilia. In its infancy, specialty pharmacy was a niche industry serving a limited number of patients with a small number of high-cost, low-volume conditions such as hemophilia and Gaucher’s disease. Today, specialty pharmacy is one of the fastest-growing sectors in the pharmacy industry. Read More>

     Four Opportunities to Tap into Biosimilar Cost Savings – September 10, 2019 Biosimilars, or biologics that are highly similar to an FDA-approved innovator biologic (the branded product), represent a total future savings potential of $54 billion between 2017 to 2026. However, actualizing these savings will require adoption at a much higher rate than we have seen to date. Read More>

     Fred’s Files for Chapter 11 Protection – September 9, 2019 Fred’s has filed for bankruptcy. The chain on Monday said it had commenced Chapter 11 proceedings in the U.S. Bankruptcy Court for the District of Delaware. The company also has begun liquidation sales at its stores, which it said are expected to close in the next 60 days. Most of Fred’s pharmacies will continue filling scripts as it continues to pursue selling them as part of the proceedings. Read More>

     FDA Finalizes Revised Guidance on REMS Revisions and Modifications – September 8, 2019 The US Food and Drug Administration (“FDA”) finalized a revised guidance on making modifications to risk evaluation and mitigation strategies (“REMS”). The document, entitled “Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry,” defines the types of changes to approved REMS, how applicants should submit changes to approved REMS and how the FDA will process these submissions. Read More>

     My Word: Middlemen Fees Driving Up Cost Of Prescriptions – September 5, 2019 The U.S. Senate Finance Committee is working on reforms to bring down the cost of prescription drugs. Senators are considering a measure that would address the lack of transparency in how pharmaceuticals are priced. Several large corporations are at the heart of the problem, and as an owner of Cloney’s Pharmacy, Inc., a local independent pharmacy, it is my hope to shed light on these corporations. Read More>

    AHA Issues New Scientific Advisory on Prescription Omega-3 Fatty-Acid Benefits – September 4, 2019 With all of the hype about the benefits of omega-3 fatty acids, how effective are they in patients with high triglyceride levels? A science advisory from the American Heart Association provides an answer, stating that prescription omega-3 fatty acid medication reduces triglyceride levels by 20% to 30% among the majority of people who require treatment for high triglyceride levels. Read More>

    USPSTF: Screen Adults 18-79 for Hepatitis C Infection – September 4, 2019 More than 4 million people in the United States have a past or current hepatitis C virus infection, and it’s the most common cause of death from a reportable infectious disease. Compounding this, there are now more than three times as many cases of acute HCV infection than there were 10 years ago, and the disease is disproportionately affecting more young people than ever before, especially injection drug users in rural areas.  Read More>

    Inappropriate Treatment for Asymptomatic Bacteriuria Is Common, Risky – September 4, 2019 inappropriate antimicrobial treatment for asymptomatic bacteriuria (ASB) is common and has been associated with longer hospital stays, a new study found, suggesting that sending urine out for testing in asymptomatic patients should be avoided. Read More>

    Updated VTE Treatment Guideline For Patients With Cancer Revealed by ASCO – September 3, 2019 Patients with cancer are at a higher risk of developing VTE, including deep vein thrombosis (DVT) and pulmonary embolism (PE), than those without cancer, and have higher rates of VTE recurrence and bleeding during VTE treatment. Consequently, VTE is an “important cause of morbidity and mortality” among cancer patients. Read More>

    Walmart Tests Dentistry and Mental Care As It Moves Deeper Into Primary Health – August 29, 2019 Walmart, the world’s biggest retailer, is moving deeper into the primary care and mental health market, opening a new clinic called Walmart Health in Georgia.The company recently updated its website with a link to Walmart Health, describing its “newest location in Dallas, GA.”  Read More>

    Are Reasonable Restraints On Drug Price Increases Doomed By Pharma Lobbying? – August 29, 2019 In a rare but important display of congressional bipartisanship, Sens. Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.) have co-sponsored the Prescription Drug Pricing Reduction Act, which includes a meaningful solution to the crisis created by runaway drug price increases. The act would put a cap on drug price increases in Medicare Part D by requiring drug manufacturers to rebate 100% of any price increase that exceeds the rate of inflation. Read More>

     Depression Drugs Market to Generate $5,000 Million – August 29, 2019 A recent study conducted by the University of Virginia Health System and published by Transparency Market Research (TMR) suggests that the depression drugs market will generate $5,000 million between 2018 and 2026. The new projection is actually the result of an anticipated decrease at a negative compound and annual growth rate of -2% over the forecasted period. Previously, the depression drugs market was valued at $6,500 million. Read More>

    FDA Issues Further Information on ARB Impurities – August 28, 2019 After the recent recall of angiotensin II receptor blockers (ARBs), the FDA released further information about how nitrosamine impurities may affect the public and how many patients have been affected. Read More>


    340B in the News

     K&L Gates Triage: Recent Developments Impacting Drug Pricing and the 340B Program: Part 2 – September 12, 2019 In Part Two of this two-part series on recent developments in pharmacy law and the 340B drug pricing program, Richard Church and Ryan Severson discuss several recent developments related to the 340B drug pricing program. Read More>