Clinical Insights — September 2016 Issue

    Welcome to the September 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

    Amjevita™ (adalimumab-atto) – September 23, 2016 – The U.S. Food and Drug Administration (FDA) approved Amjevita™ (adalimumab-atto) as a biosimilar to Humira® (adalimumab) for multiple inflammatory diseases. Read More.

    Lomaira™ (phentermine hydrochloride) Tablets September 20, 2016 – KVK Tech, Inc. announced that the FDA has approved Lomaira™ (phentermine hydrochloride USP) 8 mg tablets CIV, a low-cost, low-dose prescription medicine used for a short period of time (a few weeks) for weight reduction in adults with an initial body mass index* (BMI) of 30 or more (obese) or 27 or more (overweight) with at least one weight-related condition such as controlled high blood pressure, diabetes, or high cholesterol. Read More.

    Exondys 51™ (eteplirsen) – September 19, 2016 – The FDA approved Exondys 51™ (eteplirsen) injection, the first drug approved to treat patients with Duchenne muscular dystrophy (DMD). Exondys 51™ is specifically indicated for patients who have a confirmed mutation of the dystrophin gene amenable to exon 51 skipping, which affects about 13 percent of the population with DMD. RxSClinical Insights: Eteplirsen is a new molecular entity (not previously approved in the US). Additionally, this product was approved with an Orphan drug indication. Read More.

    Kyleena™ (levonorgestrel) Intrauterine System – September 19, 2016 – Bayer announced that the FDA approved Kyleena™ (levonorgestrel-releasing intrauterine system) 19.5 mg, a progestin-containing intrauterine system (IUS), for the prevention of pregnancy for up to five years. Kyleena™ will be available by prescription only in October 2016. Read More.

    Yosprala™ (aspirin and omeprazole) Delayed-Release Tablets – September 14, 2016 – Aralez Pharmaceuticals Inc. announced that the FDA has approved once-daily Yosprala™, the only prescription fixed-dose combination of aspirin, an anti-platelet agent, and omeprazole, a proton pump inhibitor (PPI) in the U.S. Yosprala™ is indicated for patients who require aspirin for secondary prevention of cardiovascular (CV) and cerebrovascular events and who are at risk of developing aspirin associated gastric ulcers. Read More.

    Cuvitru™ (immune globulin subcutaneous (human)) Injection – September 14, 2016 – Shire plc announced that the FDA has granted approval for Cuvitru™ [Immune Globulin Subcutaneous (Human), 20% Solution] in adult and pediatric patients two years of age and older. Cuvitru™ is a treatment for patients with primary immunodeficiency (PI), a group of more than 300 genetic disorders in which part of the body’s immune system is missing or functions improperly; it affects up to six million people worldwide. Read More.

    Erelzi™ (etanercept-szzs) Injection – August 30, 2016 – The FDA approved Erelzi™, (etanercept-szzs) for multiple inflammatory diseases. Erelzi™ is a biosimilar to Enbrel® (etanercept), which was originally licensed in 1998. Read More.

    Troxyca® ER (naltrexone and oxycodone) Extended-Release Capsules – August 19, 2016 – Pfizer Inc. announced that the FDA has approved Troxyca® ER (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules, for oral use, CII for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Troxyca® ER has properties that are expected to reduce abuse when crushed and administered by the oral and intranasal routes. However, abuse of Troxyca® ER by these routes is still possible. It is the only oxycodone with oral abuse-deterrent features described in the labeling. Read More.

    New Formulation Approval

    Invokamet® XR (canagliflozin and metformin hydrochloride extended-release (XR)) – September 21, 2016 – Janssen Pharmaceuticals, Inc. (Janssen) announced the FDA has approved Invokamet® XR—a once-daily, fixed-dose combination therapy of canagliflozin and metformin hydrochloride extended-release (XR)—for first-line use as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes when treatment with the two medications is appropriate. Read More.

    New Indication Approval

    Ilaris® (canakinumab) – September 23, 2016 – The FDA approved three new indications for Ilaris® (canakinumab). The new indications are for rare and serious auto-inflammatory diseases in adult and pediatric patients: Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS); Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD); and Familial Mediterranean Fever (FMF). All three syndromes are hereditary diseases that are characterized by periodic attacks of fever and inflammation, as well as severe muscle pain. There are no previously approved therapies for TRAPS or HIDS/MKD. Read More.

    Arzerra® (ofatumumab) – August 31, 2016 – Genmab A/S, announced that the FDA has approved a supplemental Biologics License Application (sBLA) for the use of ofatumumab (Arzerra®) in combination with fludarabine and cyclophosphamide (FC) for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL). The application, which received Priority Review in May 2016, was submitted to the FDA by Novartis under the ofatumumab collaboration between Novartis and Genmab. Read More.

    Trokendi XR® (topiramate) – August 19, 2016 – Supernus Pharmaceuticals, Inc., a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, announced that the FDA has granted tentative approval to the Company’s Supplemental New Drug Application (sNDA) requesting a label expansion for Trokendi XR® to include prophylaxis of migraine headache in adults. Read More.

    New Generic Drugs

    daptomycin (Cubicin®) – September 15, 2016 – Teva Pharmaceutical Industries Ltd., announced the launch of an authorized generic of Cubicin® (daptomycin for injection) 500 mg per vial in the United States. Read More.

    epinephrine injection (EpiPen® Auto-Injector) – August 29, 2016 – Mylan N.V., announced that its U.S. subsidiary will launch the first generic to EpiPen® Auto-Injector (epinephrine injection, USP) at a list price of $300 per generic EpiPen® two-pack carton, which represents a discount of more than 50% to the Mylan list price, or wholesale acquisition cost (“WAC”), of the branded medicine. Read More.

    nitroglycerin (Nitrostat®– August 29, 2016 – Dr. Reddy’s Laboratories Limited announced that it has launched Nitroglycerin sublingual tablets USP, 0.3 mg, 0.4 mg and 0.6 mg, a therapeutic equivalent generic version of Nitrostat in the US market on August 26, following the approval from the FDA. Read More.

    New Drug Shortage

    September 19, 2016 – Ketoprofen Capsules (Currently in Shortage)

    September 16, 2016 – Etoposide Phosphate (Etopophos) Injection (Currently in Shortage)

    September 16, 2016 – Water-Miscible Vitamin A Palmitate (Aquasol A Parenteral) (Currently in Shortage)

    September 15, 2016 – Scopolamine (Transderm Scop) Transdermal System Patch (Currently in Shortage)

    September 02, 2016 – Oxazepam Capsules (Discontinuation)

    New Drug Safety Alert

    Opioid Pain or Cough Medicines Combined with Benzodiazepines – August 31, 2016 – An FDA review has found that the growing combined use of opioid medicines with benzodiazepines or other drugs that depress the central nervous system (CNS) has resulted in serious side effects, including slowed or difficult breathing and deaths. Read More.

    New Drug Recall Alert

    Sterile Products by Wells Pharmacy Network – September 22, 2016 – Wells Pharmacy Network is voluntarily recalling all sterile human and veterinary products prepared between February 22, 2016 and September 14, 2016, and that remain within expiry due to FDA concern over a lack of sterility assurance. Read More.

    Hyoscyamine Sulfate 0.125mg by Virtus Pharmaceuticals – September 15, 2016 – Virtus Pharmaceuticals Opco II, LLC (Virtus) is voluntarily recalling seven batches of Hyoscyamine sulfate (0.125mg) to the consumer level which include the tablet, sublingual, and orally disintegrating tablet form. This recall is being initiated due to both superpotent and subpotent test results. All of these batches were manufactured by Pharmatech LLC for distribution by Virtus throughout the United States and Puerto Rico. Read More.

    GlucaGen HypoKit (glucagon [rDNA origin] for injection) – September 9, 2016 – Novo Nordisk Inc. is recalling six batches of the GlucaGen HypoKit in the U.S. due to two customer complaints from the UK and Portugal involving detached needles on the syringe with Sterile Water for Injection (SWFI). A syringe with a detached needle cannot be used as prescribed. Read more.

    United Exchange Corp Issues Voluntary Nationwide Recall of Family Care Brand Eye Wash – September 7, 2016 – Cerritos, CA, United Exchange Corp. is voluntarily recalling the following lots of Family Care Eye Wash 4 oz. due to microbial contamination. Read More.

    Lamotrigine Orally Disintegrating Tablet 200 mg – August 29, 2016 – Impax Laboratories, Inc. issued a voluntary nationwide retail level recall on August 19, 2016 for one lot of Lamotrigine Orally Disintegrating Tablet (ODT) 200 mg, NDC 0115-1529-08, Lot # 502240. The affected lot was distributed between June 13, 2016 and August 10, 2016 to wholesale distributors and retail pharmacies nationwide. Read more.

    Clinical and Pharmacy News

    Death by Prescription – September 27, 2016 – By one estimate, taking prescribed medications is the fourth leading cause of death among Americans. Americans are taking more medications than ever before. Nearly 60 to 70 percent of us take at least one prescribed drug, depending upon the estimate; for many it amounts to a fistful, potpourri of pills per day. Meanwhile, new drug approvals have reached a 19-year high. It’s a mark cheered notably for the swift minting of medications to tackle so-called “orphan diseases,” rare conditions for which few or no treatment options exist. Read More.

    Negotiation Plus: A Framework for Value-Based Drug Pricing Negotiation – September 26, 2016 – Today, pharmaceutical industry executives set the prices that Americans pay for drugs with their own profits in mind, rather than based on how well the drug works. Surveys show that roughly two-thirds of Americans—including majorities of Democrats, Republicans, and Independents—support government action to make prescription drugs more affordable. Read More.

    Humira Biosimilar Approved, But Not Interchangeable – September 26, 2016 – The FDA recently approved Amjevita (adalimumab-atto), which is a biosimilar to AbbVie’s popular anti-inflammatory drug, Humira (adalimumab). This is the fourth biosimilar that has received FDA-approval thus far. Biosimilars are biologic products that receive approval based on showing the new product is highly similar to a biological product that already has received FDA approval. Read More.

    Competition, Generics Not Always Limiting Drug Costs – September 26, 2016 – A large number of drugs that saw substantial price increases in the last four years were generics, and many of those drugs had competitors that didn’t prevent prices from declining, according to an analysis of National Average Drug Acquisition Cost (NADAC) data by Bloomberg BNA. Read More.

    NCCN Publishes New Clinical Practice Guidelines for Myeloproliferative Neoplasms – September 26, 2016 – New NCCN Guidelines for Myeloproliferative Neoplasms Focus on the Treatment of Myelofibrosis, a Rare Bone Marrow Cancer; the New Recommendations Are the Most Comprehensive Treatment Guidance Available to U.S. Clinicians Today. Read More.

    Changes in the Technician Profession – September 21, 2016 – The pharmacy technician profession is continuously evolving, with increases in medication safety standards bringing about changes in technician requirements. In an effort to identify the shifts in the pharmacy landscape that have impacted pharmacy technicians, participants in Our Voice, a journaling project powered by the American Association of Pharmacy Technicians under the leadership of Association President Judy Neville, were asked to describe major workflow changes they have experienced throughout their careers as pharmacy technicians. Read More.

    The Value of Prescription Monitoring Programs – September 20, 2016 – A recent study from Vanderbilt University in Nashville proclaimed that prescription drug monitoring programs (PDMPs) can reduce prescription drug–related overdose deaths. According to the study results published in the June issue of Health Affairs, “If Missouri adopted its own PDMP, and every state enhanced its existing program, some 600 overdose deaths would be avoided annually.” Read more.

    Measuring Best Practices in Specialty Pharmacy – September 20, 2016 – The escalation in health care costs, the growing complexity of drug therapies, the shortage of primary care physicians, the demand for improved medical outcomes, and the heightened role of the pharmacist in the patient care team are just a few of the catalysts demanding a gravitation of the pharmacy profession towards specialization. Read More.

    Postmenopausal Osteoporosis Evaluation, Diagnosis and Treatment the Focus of Updated Clinical Practice Guidelines and Algorithm Published by American Association of Clinical Endocrinologists/American College of Endocrinology – September 20, 2016 – The American Association of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE) announced the publication of new clinical practice guidelines and an accompanying algorithm to assist physicians and other medical professionals with the diagnosis, fracture risk assessment and treatment of postmenopausal osteoporosis patients. Read More.

    ISMP Updates Guidelines for Sterile Compounding – September 20, 2016 – The Institute for Safe Medication Practices (ISMP) has updated its “Guidelines for the Safe Preparation of Compounded Sterile Preparations” to address new technologies and safety strategies. Read More.

    Senators Echo Call for Investigation Over Medicaid Rebates for EpiPen – September 20, 2016 – Republicans on the Senate Finance Committee have joined the chorus calling for an investigation into Medicaid’s handling of manufacturer rebates for EpiPen. Read More.

    Behind Battle Over Drug Prices, Quiet Money from Big Pharma – September 19, 2016 – Nothing about a Washington state lawsuit called B.E. v. Teeter is as simple as it seems. It was filed this year by two hepatitis C patients against the state’s Medicaid program to help the poor gain access to drugs such as Gilead Sciences Inc.’s $1,000-a-pill cure. Read More.

    FDA Launches Competition to Spur Innovative Technologies to Help Reduce Opioid Overdose Deaths – September 19, 2016 – The FDA announced the 2016 Naloxone App Competition, a public contest focused on developing innovative technologies to combat the rising epidemic of opioid overdose. Read More.

    Medical Costs Jump in August by Largest Amount in 32 Years, CPI Shows – September 16, 2016 – Higher rents and surging medical and prescription-drug costs are putting a dent in the wallets and pocketbooks of American consumers, new government data show. The consumer price index rose 0.2% in August, according to a government index that tracks the cost of living. Read More.

    Modification of the Dosage Regimen for Nivolumab – September 13, 2016 – The FDA modified the dosage regimen for nivolumab (Opdivo, Bristol-Myers Squibb Co.) for the currently approved indications for renal cell carcinoma, metastatic melanoma, and non-small cell lung cancer. The currently approved recommended dosage regimens were modified to 240 mg intravenously (IV) every two weeks. Read More.

    Hypertension Uncontrolled in 70% of Americans Over 65 – September 13, 2016 – About 25% of people with Medicare Part D prescription drug insurance are not taking their antihypertensive medication as prescribed, according to Tom Frieden, MD, MPH, the director of the Centers for Disease Control and Prevention (CDC), increasing their risk for heart and kidney disease, stroke and death. Read More.

    Benefits of Statins Underestimated; Harms Exaggerated – September 9, 2016 – The benefits of statin therapy have been underestimated, and the harms exaggerated, because of a failure to acknowledge properly both the wealth of evidence from randomized trials and the limitations of other types of studies, according to a new review. Read More.

    New Technology Could Potentially Compete with Pharmacy Supplement Sales – September 8, 2016 – Multiply Labs has designed what it claims to be the “first-ever personalized supplement pill.” Will it ultimately wipe out pharmacy’s supplement market share? The short answer is no, at least not for the time being. Read More.

    Federal Survey Finds 119 Million Americans Use Prescription Drugs – September 8, 2016 – Nearly half of all Americans over the age of 12 take prescription pain relievers, tranquilizers, sedatives or stimulants, according to a federal survey. And 16 percent of the time those drugs are misused by nearly 19 million Americans. Health officials are calling for more drug treatment, but also for more care in prescribing drugs in the first place. Read More.

    How Much Do Drugs for Rare Diseases Add to Health Care Spending? – September 7, 2016 – Rising concerns about spending on prescription drugs that treat rare diseases are overblown, according to an analysis published Wednesday in the journal Health Affairs. Read More.

    How PBMs Make the Drug Price Problem Worse – August 31, 2016 – Recent price increases on the lifesaving allergy drug EpiPen have spawned a conversation about how drug pricing works in this country. Unfortunately, the focus on this one product by a one-note media and headline chasing polls has obscured a far bigger issue — the corrosive role of Pharmacy Benefit Managers (PBMs) who oversee drug prescription plans in driving up consumer prices. Read More.

    340B in the News

    The Drug Discount Program (340B) Saves Lives – September 25, 2016 – The healthcare industry is undergoing dramatic transformation as we shift from fee-for-service reimbursement to a fee-for-value payment system, promoting the value and outcome of the healthcare services we deliver. We’re focused on providing the best care for the people we serve, measuring the efficiency of our healthcare delivery and striving to improve outcomes at a lower cost. Read More.

    Crucial Drug 340B Discount Program at Risk – September 24, 2016 – Regional One Health is a safety-net provider. That means we treat all sick people regardless of their ability to pay. Seventy-seven percent of our patients are on Medicaid, Medicare or lack health insurance altogether. A little-known federal statute called the 340B drug discount program helps us care for the neediest in our community. Read More.

    New 340B Dispute Resolution Process: Will It Level the Playing Field? – August 29, 2016 – On August 12, HRSA published a formal proposed rule regarding a 340B Drug Pricing Program administrative dispute resolution (ADR) process. HRSA’s use of the administrative rulemaking process is a rare occasion given its perceived limited rulemaking authority granted by Congress. Read More.

    Final Drug Discount Program Guidance Moves Closer to Release – September 8, 2016 – Final guidance intended to provide more clarity for drug makers and safety-net providers participating in the federal 340B drug discount program is moving closer to release. The White House Office of Management and Budget started its review Sept. 1 of the final guidance document (RIN:0906-AB08), according to the OMB’s website. Read More.

    Commentary: Continue Drug Pricing Program for Families in Need – September 1, 2016 – Last year, as my little girl was transitioning to adulthood, she experienced headaches so painful that we raced to the hospital fearing meningitis. The doctors at Dell Children’s quickly ruled out that risk, but it took two months to pinpoint Ariana’s condition, a normally benign disease that was attacking her central nervous system called juvenile xanthogranuloma. Read More.