Clinical Insights: August 4, 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

    Vyxeos™ (cytarabine and daunorubicin) – August 3, 2017 – The U.S. Food and Drug Administration approved Vyxeos™ for the treatment of adults with two types of acute myeloid leukemia (AML): newly diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Vyxeos™ is a fixed-combination of chemotherapy drugs daunorubicin and cytarabine. Read More.

    Mavyret™ (glecaprevir and pibrentasvir) – August 3, 2017 – The U.S. Food and Drug Administration approved Mavyret™ (glecaprevir and pibrentasvir) to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis, including patients with moderate to severe kidney disease and those who are on dialysis. Mavyret™ is the first treatment of eight weeks duration approved for all HCV genotypes 1-6 in adult patients without cirrhosis who have not been previously treated. Read More.

    Idhifa® (enasidenib) – August 1, 2017 – The U.S. Food and Drug Administration granted regular approval to enasidenib (Idhifa®, Celgene Corp.) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test. Read More.


    New Formulation Approval

    No new updates.


    New Indication Approval

    Imbruvica® (ibrutinib) – August 2, 2017 – The U.S. Food and Drug Administration expanded the approval of Imbruvica® (ibrutinib) for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more treatments. This is the first FDA-approved therapy for the treatment of cGVHD. Read more.

    Epclusa® (Sofosbuvir/Velpatasvir) – August 1, 2017 – Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved updated labeling for Epclusa® (sofosbuvir 400mg/velpatasvir 100mg), the first all-oral, pan-genotypic, once-daily single tablet regimen (STR) for the treatment of adults with chronic hepatitis C virus (HCV) infection, to include use in patients co-infected with HIV. Read more.

    Kalydeco® (ivacaftor) – New Expanded Indication Approval – August 1, 2017 – Vertex Pharmaceuticals Incorporated announced that the U.S. Food and Drug Administration (FDA) has approved Kalydeco® (ivacaftor) for use in more than 600 people with cystic fibrosis (CF) ages 2 and older who have one of five residual function mutations that result in a splicing defect in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. This approval was based on Phase 3 clinical data for Kalydeco® in these mutations and follows the FDA’s approval of Kalydeco® in May 2017 for 23 other residual function mutations, which was based on analyses of in vitro data. Read more.

    Opdivo® (nivolumab) – July 31, 2017 – The U.S. Food and Drug Administration granted accelerated approval to nivolumab (Opdivo®, Bristol-Myers Squibb Company) for the treatment of patients 12 years and older with mismatch repair deficient (dMMR) and microsatellite instability high (MSI-H) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. Read more.

    Abilify Maintena® (aripiprazole) – July 28, 2017 – Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S announced Abilify Maintena® (aripiprazole) for extended-release injectable suspension was approved by the U.S. Food and Drug Administration for the maintenance monotherapy treatment of bipolar I disorder (BP‑I) in adults. Read more.


    New Drug Shortage

    No new updates.


    New Drug Recall Alert

    0.9% Sodium Chloride Injection by ICU Medical – July 31, 2017 – ICU Medical, Inc. is voluntarily recalling one lot of 0.9% Sodium Chloride Injection, USP 1000 mL to the hospital/user level due to a confirmed customer complaint of particulate matter identified as stainless steel within a single flexible container. Read more.

    Compounded Triamicinolone and Moxifloxacin Product for Intravitreal Injection – July 28, 2017 – FDA received adverse event reports on April 5 and June 1, 2017, concerning at least 43 patients who were administered intravitreal (eye) injections of a drug containing triamcinolone (steroid) and moxifloxacin (anti-infective) compounded by Guardian Pharmacy Services in Dallas, Texas. Read more.

    Cyclobenzaprine HCl and Amantadine HCl – July 28, 2017 – Apace Packaging LLC is voluntarily recalling one lot of Cyclobenzaprine HCl Tablet, USP 5 mg 50ct Unit Dose, NDC# 50268-190-15, Lot Number 16710 and one lot of Amantadine HCl Capsule, USP 100 mg 50ct Unit Dose NDC# 50268-069-15, Lot Number 16710 to the Retail level. These products have been recalled due to a potential mislabeling. Read more.


    New First Time Generic

    Transderm Scop® (scopolamine) – First-time Generic Launch – July 31, 2017 – Perrigo Company plc and its co-development partner Aveva Drug Delivery Systems, Inc., an Apotex Company, announced the prescription pharmaceutical launch of scopolamine 1.5 mg transdermal system patch, the AB rated generic equivalent to Transderm Scop® (scopolamine 1.5 mg). Read more.

    Epiduo® (adapalene/benzoyl peroxide) – July 28, 2017 – Teva Pharmaceutical Industries Ltd. announced the launch of generic Epiduo®1 (adapalene and benzoyl peroxide) gel, 0.1%/2.5% in the U.S. Teva was the first company to file a generic application for Epiduo and is expected to benefit from 180-days of generic product exclusivity. Read more.


    Clinical and Pharmacy News

    Errors in Opioid Prescribing for Adult Outpatients Common – August 4, 2017 – For adults receiving opioid medication prescriptions, errors are common, and most often occur on handwritten prescriptions, according to research published recently in the Journal of Opioid Management. Read more.

    Wal-Mart, Walgreens, CVS Turn Up the Heat on Generic Drugmaker Deals – August 3, 2017 – The largest U.S. retail pharmacies, including Wal-Mart Stores Inc. and Walgreens Boots Alliance Inc., are wielding more leverage when buying generic drugs, accelerating a decline in prices likely to affect drug companies for some time, industry experts said on Thursday. Read more. 

    Americans Taking More Prescription Drugs Than Ever – August 3, 2017 – A new survey finds 55 percent of Americans regularly take a prescription medicine — and they’re taking more than ever. Those who use a prescription drug take four, on average, and many also take over-the-counter drugs, vitamins and other dietary supplements, the survey done by Consumer Reports shows. Read more. 

    NASP President Discusses Affect of DIR Fees on Medicare Patients, Specialty Pharmacies – August 3, 2017 – Direct and indirect remuneration (DIR) fees are significantly impacting specialty pharmacies and seniors enrolled in Medicare Part D. Pharmacy benefit managers (PBMs) are charging DIR fees retroactively, surprising pharmacies with bills months after medications have already been dispensed to seniors. Read more.

    CVS Health Removes 17 Drugs from Formulary, Adds Outcomes-Based Program – August 2, 2017 – CVS Health on Wednesday put out its standard control formulary for 2018, days after competitor Express Scripts announced its own drug coverage list for next year. The pharmacy benefit manager (PBM) claims its management approach will have saved its clients a cumulative $13.4 billion from 2012 through 2018. Read more.

    Brace for A Barrage of Biosimilars – August 2, 2017 – On March 23, 2010, former President Obama signed the Patient Protection and Affordable Care Act (ACA) into law, which amended the Public Health Service Act to create an abbreviated licensure pathway for biological products that are demonstrated to be biosimilar to or interchangeable with an FDA-licensed biological product. Read more.

    Regulation, Competition Needed to Lower Drug Prices, Says Panel – August 2, 2017 – Seven years ago, David Mitchell was diagnosed with myeloma, an incurable but treatable blood cancer. The combination of drugs he requires costs $20,000 per injection — $440,000 for one year of treatment — and regularly changes as the cancer becomes resistant to current treatment. Read more.

    Cardinal Health Profit Declines as Generic Drug Prices Deflate – August 2, 2017 – Cardinal Health reported an 18 percent drop in earnings in its fourth quarter, driven by dwindling generic drug prices, the company said Wednesday. The Dublin, Ohio-based pharmaceutical and medical products distributor saw its earnings fall to $274 million for the quarter ended June 30, down from $333 million from the same period the year before. Revenue was up 5 percent to $33 billion. Read more. 

    Your Prescription Expiration Date Might Be Inaccurate – August 2, 2017 – Throwing out a few bottles of expired prescriptions you come across in your medicine cabinet doesn’t seem that wasteful, right? But for pharmacies and hospitals, the pile of expired drugs they’re required to toss out adds up to about $200,000 per hospital each year. Read more.

    If Trump Wanted, He Could Take Steps to Lower Soaring Drug Prices – August 1, 2017 – After last year’s election, Donald Trump declared his determination “to bring down drug prices.” As president, he’s now reportedly cooking up an executive order aimed at cutting regulations for drug companies, which probably won’t do much to lower prices but should please industry execs. Read more.

    The generic drug industry has brought huge cost savings. That may be changing – August 1, 2017 – A decade ago, physicians who treat epilepsy got what seemed like a piece of good news: Eight companies had received federal approval to sell a generic version of an injectable lifesaving drug. Doctors liked the brand-name drug Cerebyx because it was safer and easier to use than a previous medicine that stopped seizures but could cause terrible skin reactions. The only problem was that it was too expensive for many hospital pharmacy budgets. A widely available and cheaper generic version would remove those cost barriers — or so doctors thought. Read more.

    Reining in Drug Prices: Easier Said than Done – August 1, 2017 – Some of the so-called solutions for reducing the price of prescription drugs are not as easy as they seem, experts said at a panel here hosted by the Alliance for Health Policy. Ideas such as having the federal government negotiate drug prices or allowing importation of prescription drugs from other countries “sound good, but they’re probably not going to work, or get through Congress,” former House member Henry Waxman (D-Calif.) said at the event on Friday. Read more.

    Express Scripts Shuts Out 64 Branded Drugs From 2018 Formulary – July 31, 2017 – Express Scripts, a top-three pharmacy benefit manager (PBM) in the U.S., will exclude an additional 64 drugs from its national listing of preferred drugs next year, sending shares in several biotechs affected spinning in Monday trading. Read more.

    Advocates Disagree on the Impact of DIR Fees on Part D Drugs – July 31, 2017 – Advocates on both sides of the ongoing debate surrounding direct and indirect remuneration (DIR) fees continue to argue about the real world impact these fees have across the health care landscape. The Pharmaceutical Care Management Association (PCMA) recently commissioned Milliman to write report about DIR fees and how they may be beneficial to the federal government. Read more.


    340B in the News

    CMS’s 340B Proposal Is Likely Unlawful—Here’s Why – August 4, 2017 – As has been widely reported in the trade press, the Centers for Medicare & Medicaid Services (CMS) recently promulgated an extraordinary proposal under Medicare to reduce reimbursement for drugs used in hospital outpatient departments when those drugs have been purchased under the 340B Program. Read more.

    GOP Should Tackle High Drug Costs – August 3, 2017 – Republicans not only hold the White House, but both chambers of Congress as well, thanks in no small part to rural voters. If they want to hold on to that power into 2018 and beyond, they’d be wise not to ignore the base that gave it to them. Read more. 

    Update on Successes and Hurdles in Improving 340B Program Oversight – August 2, 2017 – On July 18, 2017, the Government Accountability Office (GAO) issued a follow-up report entitled “Update on Agency Efforts to Improve 340B Program Oversight.” In its initial report in 2011, the GAO highlighted the inherent weakness of federal 340B Drug Pricing Program (referred to as the “340B Program”) oversight, which is administered by the Health Resources and Services Administration (HRSA), Office of Pharmacy Affairs (housed within the U.S. Department of Health and Human Services). Read more.