Clinical Insights: September 15, 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

    Aliqopa™ (copanlisib) – September 14, 2017 – The U.S. Food and Drug Administration granted accelerated approval to Aliqopa™ (copanlisib) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior treatments known as systemic therapies. Read more. 

    Mvasi™ (bevacizumab-awwb) – September 14, 2017 – The U.S. Food and Drug Administration approved Mvasi™ (bevacizumab-awwb) as a biosimilar to Avastin® (bevacizumab) for the treatment of multiple types of cancer. Mvasi™ is the first biosimilar approved in the U.S. for the treatment of cancer. Read more. 

    Mylotarg™ (gemtuzumab ozogamicin) – September 1, 2017 – The U.S. Food and Drug Administration approved Mylotarg™ (gemtuzumab ozogamicin) for the treatment of adults with newly diagnosed acute myeloid leukemia whose tumors express the CD33 antigen (CD33-positive AML). The FDA also approved Mylotarg™ for the treatment of patients aged two years and older with CD33-positive AML who have experienced a relapse or who have not responded to initial treatment (refractory). RxS Clinical Insight: Mylotarg™ (gemtuzumab ozogamicin) is approved with an orphan designation. Read more.

    Kymriah™ (tisagenlecleucel) – August 30, 2017 – The U.S. Food and Drug Administration issued a historic action making the first gene therapy available in the United States, ushering in a new approach to the treatment of cancer and other serious and life-threatening diseases. The FDA approved Kymriah (tisagenlecleucel) for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL). Read more.

    Benznidazole – August 29, 2017 – The U.S. Food and Drug Administration granted accelerated approval to benznidazole for use in children ages two to 12 years old with Chagas disease. It is the first treatment approved in the United States for the treatment of Chagas disease. Read more.

    Vabomere™ (meropenem/vaborbactam) – August 29, 2017 – The U.S. Food and Drug Administration approved Vabomere™ for adults with complicated urinary tract infections (cUTI), including a type of kidney infection, pyelonephritis, caused by specific bacteria. Vabomere is a drug containing meropenem, an antibacterial, and vaborbactam, which inhibits certain types of resistance mechanisms used by bacteria. Read more.

    Cyltezo™ (adalimumab-adbm) – August 25, 2017 – Boehringer Ingelheim Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) approved Cyltezo™, a biosimilar to Humira®, in a pre-filled syringe for the treatment of multiple chronic inflammatory diseases. Read more.


    New Formulation Approval

    Tracleer® (bosentan) – September 6, 2017 – The FDA granted a new indication for a new 32-mg tablet for oral suspension for bosentan (Tracleer, Actelion Pharmaceuticals) for use in pediatric patients aged three years and older with idiopathic or congenital pulmonary arterial hypertension (PAH), to improve pulmonary vascular resistance, which is expected to result in an improvement in exercise ability. Read more.


    New Indication Approval

    Afluria® Quadrivalent (influenza vaccine) – New Expanded Indication Approval – September 14, 2017 – Seqirus announced that the U.S. Food and Drug Administration (FDA) has approved Afluria® Quadrivalent (Influenza Vaccine) for use in people five years of age and older, extending the company’s broad portfolio of influenza vaccine offerings. Afluria® Quadrivalent, which was first approved in the U.S. in August 2016 for people aged 18 and older, helps protect against two influenza A strain viruses and two B strain viruses. Read more.

    Actemra® (tocilizumab) – New Orphan Indication Approval – August 30, 2017 – Genentech announced that the U.S. Food and Drug Administration (FDA) has approved Actemra® (tocilizumab) intravenous injection for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in patients two years of age and older. Read more.

    Austedo® (deutetrabenazine) – New Indication Approval – August 30, 2017 – Teva Pharmaceutical Industries Ltd., announced that the U.S. Food and Drug Administration (FDA) has approved Austedo® (deutetrabenazine) tablets for the treatment of tardive dyskinesia in adults. Austedo® was previously approved for the treatment of chorea associated with Huntington’s disease in April 2017. Austedo® is the first and only FDA-approved product to treat both tardive dyskinesia in adults and chorea associated with Huntington’s disease. Read more.

    Faslodex® (fulvestrant) – Expanded Indication Approval – August 28, 2017 – AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has approved Faslodex (fulvestrant) 500mg as monotherapy for expanded use in women with hormone-receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer, who have gone through menopause and have not received previous endocrine therapy. Read more.


    New Drug Shortage

    September 13, 2017

    September 12, 2017

    September 11, 2017

    September 8, 2017

    September 1, 2017


    New Drug Recall and Safety Alerts

    Activase (alteplase) 100mg by Genentech – New Drug Recall Alert – September 9, 2017 – Genentech is voluntarily recalling three lots of Activase (alteplase) 100mg vials, that were co-packaged with Sterile Water for Injection, to the hospital level. The vials of Sterile Water for Injection, manufactured by Hospira Inc., a Pfizer company, and packaged with Activase 100 mg, may be cracked or chipped at the neck of the vial and leaking. Read more.

    Kayexalate (sodium polystyrene sulfonate) – New Drug Safety Alert – September 9, 2017 – FDA is recommending that patients avoid taking the potassium-lowering drug sodium polystyrene sulfonate (Kayexalate) at the same time as other medicines taken by mouth. A study found that sodium polystyrene sulfonate binds to many commonly prescribed oral medicines, decreasing the absorption and therefore effectiveness of those oral medicines. To reduce this likelihood, we recommend separating the dosing of sodium polystyrene sulfonate from other orally administered medicines by at least three hours. Read more.

    Unexpired Lots of Oxytocin Compounded with Either Lactated Ringers or Lactated Ringers and Dextrose by PharMEDium – Drug Recall Alert – September 1, 2017 – PharMEDium Services, LLC (PharMEDium) is voluntarily recalling all unexpired lots of Oxytocin compounded with Lactated Ringers and all unexpired lots of Oxytocin compounded with Lactated Ringers and Dextrose products that were produced between July 6, 2017 and August 29, 2017 to the hospital/user level. The recall is being issued based on laboratory test results indicating a lower than expected potency on certain lots of Oxytocin compounded with Lactated Ringers and Oxytocin Compounded with Lactated Ringers and Dextrose which would lead to a lower dose being administered. Read more.

    Keytruda (pembrolizumab) in Patients with Multiple Myeloma – Drug Safety Communication – August 31, 2017 – Based on data from two recently halted clinical trials, the U.S. Food and Drug Administration is issuing this statement to inform the public, healthcare professionals, and oncology clinical investigators about the risks associated with the use of Keytruda (pembrolizumab) in combination with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) for the treatment of patients with multiple myeloma. Keytruda (pembrolizumab) is not approved for treatment of multiple myeloma. Read more.

    Vancomycin Hydrochloride for Injection, USP, 750 mg/vial by Hospira – Drug Recall Alert – August 31, 2017 – Hospira is voluntarily recalling one lot of Vancomycin Hydrochloride for Injection, USP, 750 mg/vial (NDC 0409-6531-02) lot 632153A, to the hospital/retailer level. The recall was due to a confirmed customer report for the presence of particulate matter, confirmed as glass, within a single vial. To date, Hospira has not received reports of any adverse events associated with this issue for this lot. Read more.


    New First Time Generic

    No new updates.


    Clinical and Pharmacy News

    What Does It Cost to Create a Cancer Drug? Less Than You’d Think – September 15, 2017 – What does it really cost to bring a drug to market? The question is central to the debate over rising healthcare costs and appropriate drug pricing. United States President Donald Trump campaigned on promises to lower the costs of drugs. But numbers have been hard to come by. For years, the standard figure has been supplied by researchers at the Tufts Center for the Study of Drug Development: US$2.7 billion (S$3.6 billion) each, in 2017 dollars. Read more. 

    FDA OKs Prescription-only App to Help Patients with Substance Use Disorders – September 15, 2017 – Officials with the FDA have granted marketing permission for the first mobile medical application (Reset, Pear Therapeutics) to help treat people with substance use disorders (SUD), including alcohol, cocaine, marijuana and stimulant SUDs. The application is not intended to be used to treat opioid dependence. Read more. 

    Curing AIDS, The Time Is Now: Gene-Editing Technology May Eliminate HIV – September 15, 2017 – Excision BioTherapeutics secured $10 million in seed funding to enter human clinical trials using a CRISPR-based gene editing platform to eradicate HIV. The financing, led by ARTIS Ventures, will give Excision the first chance to remove the HIV-1 genome from all human cells and tissues, according to a press release. Read more.

    Retail Pharmacy Again Steps to The Plate as The South Recovers from The Latest Hurricane – September 14, 2017 – Recent hurricane relief efforts have expanded to incorporate the aftermath of Hurricane Irma in Florida and neighboring southern states as retail pharmacy operators continue to provide support to the associates and customers impacted by floods and power outages. Read more.

    Insurers Cutting Back on Drug Coupons Amid Concerns Over Consumer Costs – September 14, 2017 – With many drug prices rising, consumers often pull out coupons or discount cards from drugmakers to save money when they buy medications at pharmacies. But some insurers, including in Illinois, are limiting how those discounts could be applied amid concerns they’re driving up healthcare costs for everyone. Read more.

    HIVMA Releases Chronic Pain Treatment Guidelines for Patients With HIV – September 14, 2017 – All patients with HIV should be screened for chronic pain because research has shown that many suffer from it, according to guidelines published by the HIV Medicine Association. For those who have chronic pain, HIV clinicians should take a multidisciplinary approach using nondrug treatment as the first-line option, the guidelines’ authors wrote in Clinical Infectious Diseases. Read more. 

    New Gene-Therapy Treatments Will Carry Whopping Price Tags – September 14, 2017 – The first gene therapy treatment in the United States was approved recently by the Food and Drug Administration, heralding a new era in medicine that is coming faster than most realize — and that perhaps few can afford. The treatment, Kymriah, made by Novartis, is spectacularly effective against a rare form of leukemia, bringing remissions when all conventional options have failed. It will cost $475,000. Read more.

    Specialty Drug Prices Increase at Fastest Rate in Over a Decade – September 14, 2017 – Retail prices for specialty prescription drugs widely used by older Americans ballooned by an average of 9.6 percent between 2014 and 2015, the highest increase since at least 2006, while retail prices for some generic drugs saw more mixed results, with 11 percent showing price increases according to two new AARP Public Policy Institute reports released Thursday. Read more.

    Tips for Helping Seniors with Their Medications – September 13, 2017 – I recently received a request from a pharmacy technician who fills in at our store now and again. He is in nursing school, and in his pharmacology class they were tasked with coming up with useful ways to teach seniors medication adherence and help them increase their understanding of their medications. He asked me if I had any specific tools I use with senior patients to fulfill these specific needs. Read more.

    Drug Plans Are Fighting States to Keep Prices in the Dark – September 13, 2017 – California is the biggest state so far to seek to pull back the curtain on pharmacy-benefits managers, as the industry aggressively tries to thwart a wider push for transparency. Read more.

    PBMs Look to the Future – September 12, 2017 – Pharmacy benefits managers have evolved from claims processing to home delivery, managing formulary, specialty pharmacy, and negotiating with manufacturers. With the ongoing backlash against them—complaints of lack of transparency and regulation, conflicts of interest created through owning specialty and mail order pharmacies, perverse incentives, and rising pharmacy costs—PBMs may decide to make some changes in how they operate. Read more.

    Express Scripts’ New Formulary Favors Biosimilars, Cuts Opioids – September 12, 2017 – The biosimilar Zarxio is in and the painkillers Opana ER and extended release oxycodone are out on Express Scripts’ 2018 National Preferred Formulary (NPF). These are just two of the changes the PBM made among the 64 new drug exclusions for the 2018 benefit year. Read more.

    Are You Keeping Your Patients’ Digital Info Safe? – September 12, 2017 – Pharmacists strive to do no harm. However, they could be unintentionally exposing patients to risk through gaps in cybersecurity and outdated technology. Across the globe, healthcare systems have become the targets of ransomware attacks—attacks where hackers gain access and essentially kidnap data and patient information to hold it hostage until a ransom is paid. Read more.

    A New Study Undermines Big Pharma’s Justification for Charging High Drug Prices – September 11, 2017 – It’s hard to get a clear estimate on how much it costs to develop a new medication from start to finish, with some estimating it costs more than $2 billion. But a new study, published Monday, found that the cost to develop a new cancer drug is closer to $648 million, a much lower figure. Read more.

    Providers Reduce Waste to Work Around Ballooning Drug Prices – September 11, 2017 – Cleveland Clinic is one of the most prolific users of the heart drugs nitroprusside and isoproterenol, so when their respective prices surged 30-fold and 70-fold over a three-year span, it caught the provider’s attention. Read more.

    State Monitoring Program Reduces Prescription Drug Abuse – September 10, 2017 – Pennsylvania was one of the last states to implement a prescription drug monitoring program, but it has been critical in reducing doctor shopping, the state’s physician general said. Read more.


    340B in the News

    CMS’s Proposed 340B Payment Cuts Draw Both Criticism and Praise – September 14, 2017 – Healthcare organizations took up expected positions to the Centers for Medicare & Medicaid Services’ (CMS’s) proposed cuts to hospital 340B drug payments in comments released this week, just in time for the agency’s Sept. 11 deadline. In the agency’s proposed rule revising certain Medicare payment policies, promulgated in July, hospitals would be paid 22.5 percent less than the average sales price (ASP) under the 340B program, instead of the 6 percent above the ASP they are currently paid. Read more.

    Hospital Groups Oppose 340B Cuts, Site Neutral Payments in Comments To CMS – September 13, 2017 – In comments to the CMS released this week, hospital organizations fervently opposed the agency’s proposals to cut hospital 340B drug payments and reduce reimbursement for off-campus hospital outpatient departments. Read more.

    Hospitals and Cancer Doctors Urge Trump Administration to Withdraw Medicare Drug Reimbursement Proposal – September 11, 2017 – A Trump administration agency proposal to cut Medicare drug payments to hospitals serving poor and rural Americans is counterproductive and would actually reduce access to care, a group of over 1,300 hospitals says in comments submitted to the U.S. Department of Health and Human Services (HHS). Read more.

    Community Oncology Alliance Backs Hospital Payment Cuts In 340B Rule – September 11, 2017 – In the ongoing battle between oncologists and hospitals over the 340B drug program, the Community Oncology Alliance has sent a letter to the Centers for Medicare and Medicaid Services supporting the agency’s payment cuts to hospitals. Read more.

    The Swamp Is Incoherent on the Rule of Law, Thanks to Pharma – September 9, 2017 – The bipartisan Washington, DC “consensus” has so many blind spots, you’d think its exponents lived in a black box. Recently, it has become clear that one of the biggest of those blind spots is the federal government’s treatment of the pharmaceutical industry. Read more.

    Another View: 340B Drug Pricing Plan Vital to Low-Income Health – September 8, 2017 – One can only imagine the hardship associated with telling a patient who lives below the poverty line that they are unable to afford life-saving medications to help manage their chronic disease or fight cancer. However, thanks to a newly embattled federal initiative – the 340B Drug Pricing Program – our most vulnerable patients have access to the medication they need. Read more.

    Proposed Changes to 340B May Curb Hospital Abuses – September 2, 2017 – Outpatient branded drug sales in the 340B Drug Pricing Program now amount to almost 8 percent of the total market, well up from 5.4 percent in 2012, according to a whitepaper from the Berkeley Research Group. The new figure highlights the dramatic growth of 340B and fuels concerns about the abuse that government officials believe is rampant in the program. Read more.

    Advisory Group Warns CMS Against 340B Medicare Reimbursement Cuts – August 28, 2017 – The CMS Advisory Panel on Hospital Outpatient Payment recently called on the federal agency to abandon proposed changes to the 340B Drug Pricing Program in 2018, which would reduce Medicare reimbursement to qualifying hospitals for drugs acquired under the program. Read more.