RxStrategies Clinical Insights – September 2014, Issue 1

    Welcome to this month’s RxStrategies Clinical Insights, a concise communication to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy market place.


    New Drug Approvals

    Keytruda® (pembrolizumab) – New Orphan Drug Approval

    September 4, 2014 – The U.S. Food and Drug Administration approvedKeytruda® (pembrolizumab) for treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs. Keytruda® (pembrolizumab) is the first approved drug that blocks a cellular pathway known as PD-1 (programmed death receptor -1), which restricts the body’s immune system from attacking melanoma cells. RxS Insight: Merck’s Keytruda® is a highly selective IgG4 antibody dosed by IV infusion every 3 weeks. Merck expects the drug to be available by mid-September 2014 and it is estimted the cost will be $12.5k per month. Bristol-Myers Squibb has a competitor product in the pipeline that was recently approved in Japan.  Read More>

    New Drug Indications

    • Promacta® (eltrombopag) – New Indication – GlaxoSmithKline announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for the once-daily use of Promacta® (eltrombopag) in patients with severe aplastic anemia (SAA) who have had an insufficient response to immunosuppressive therapy (IST).  Read More>
    • Zorvolex® (diclofenac) – New Indication – August 25, 2014The U.S. Food and Drug Administration (FDA) approved Zorvolex® (diclofenac) for the management of osteoarthritis (OA) pain, the company announced today. OA pain is the second indication for Zorvolex®, first approved by the FDA in October 2013 for mild-to-moderate acute pain in adults.  Read More>
    • Eliquis® (apixaban) – New Indication – August 21, 2014 – The U.S. Food and Drug Administration approved Eliquis® (apixaban) for the Treatment of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE), and for the reduction in the risk of recurrent DVT and PE following initial therapy. Read More>

    New Drug Formulations

    • Kabiven® and Perikabiven® (parenteral nutrition (PN) products) – New Formulation Approval; August 26, 2014 – Fresenius Kabi announced it received approval from the U.S. Food and Drug Administration for Kabiven® and Perikabiven® intravenously infused solutions of lipids, dextrose, amino acids and electrolytes in three-chamber parenteral nutrition bags that efficiently deliver these nutrients in volumes and concentrations that meet the nutritional needs of most patients.  Read More>
    • Triumeq® (abacavir, dolutegravir and lamivudine) – New Formulation Approval; August 22, 2014 – ViiV Healthcare announced that the U.S. Food and Drug Administration has approved Triumeq® (abacavir 600mg, dolutegravir 50mg and lamivudine 300mg) fixed-dose tablets for the treatment of HIV-1 infection. Triumeq® represents the first dolutegravir-based fixed-dose combination, offering that combines the integrase strand transfer inhibitor (INSTI) dolutegravir, (Tivicay®) with the nucleoside reverse transcriptase inhibitors (NRTIs) abacavir and lamivudine (Epzicom®).  Read More>
    • Arnuity™ Ellipta® (fluticasone furoate inhalation powder) – New Formulation Approval; August 20, 2014 – GlaxoSmithKline announced that the Food and Drug Administration has approved Arnuity™ Ellipta® (fluticasone furoate inhalation powder), a once-daily inhaled corticosteroid (ICS) for maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older. Arnuity is not indicated for relief of acute bronchospasm.
    • Arnuity (fluticasone furoate) is administered once daily via the dry powder inhaler called Ellipta. Read More>


    New Generic Approvals

    • Entecavir – New Generic Approval; September, 4, 2014 – Teva Pharmaceutical Industries Ltd., announced the launch of the generic equivalent to Baraclude® (Entecavir) Tablets, 0.5mg and 1mg, in the United States. Teva was first to file, making the product eligible for 180 days of marketing exclusivity. Read More>
    • Megesterol Acetate – New Generic Approval; August 28, 2014. TWi Pharmaceuticals, Inc. announced that it has received final approval from the U.S. Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for megestrol acetate 125mg/ml oral suspension, the generic equivalent to Par Pharmaceutical’s Megace® ES. TWi is the first-to-file and under Hatch Waxman rules, it will be entitled to 180 days of marketing exclusivity. Read More> 
    • Amoxicillin Extended-Release Tablets – Authorized Generic; August 25, 2014 – Fera Pharmaceuticals announced that it has been selected by Pragma Pharmaceuticals to launch Amoxicillin Extended-Release Tablets, the authorized generic for Moxatag®.  Read More> 

    New Drug Shortages

    August 28, 2014

    August 26, 2014

    Pharmacy News

    • U.S. to Allow Pharmacies to Take Back Unused Prescription Drugs; September 4, 2014 – Federal authorities will soon allow pharmacies and clinics to take back unused prescription drugs from customers in an effort to get addictive painkillers off the street. The change, to be issued in new government regulations, will address a long-standing complaint from those fighting opioid addiction that government rules make it difficult to safely dispose of unused pills. Under current rules for controlled substances, even a pharmacy that fills a painkiller prescription may not take back any unused pills. Read More>
    • New Genzyme pill will cost patients $310,250 a year; September 2, 2014 – Cambridge biotech Genzyme has priced its new pill to treat Gaucher disease at $310,250 a year for the small population of US patients suffering from the rare genetic disorder. The price — listed as $23,800 for a 28-day supply — is slightly higher than the $300,000 average annual cost of Genzyme’s flagship Gaucher treatment Cerezyme, a protein-based enzyme replacement therapy that patients typically take by two-hour infusions every two weeks.
    • New Guidelines for Treating Form of Advanced Breast Cancer; September 2, 2014 -A leading group of oncologists has released updated guidelines for the treatment of the major form of advanced breast cancer.  Read More>
    • PBMs fight new payment, trade secret regulations; September 1, 2014 -The pharmacy benefits industry is challenging a new state law, trying to protect a key management tool that insurers, employer groups and public payers have been relying on for cost stability. The Pharmaceutical Care Management Association wants to overturn a new Iowa law regulating maximum allowable cost lists for generic drugs, arguing that any state involvement in the practice is preempted by the federal Employee Retirement Income Security Act’s national framework. Read More>
    • New cholesterol guideline outperforms ATP III; August 25, 2014 – The controversial 2013 American Heart Association/American College of Cardiology guideline on the assessment of cardiovascular risk matches statin use to patients’ total plaque burden better than did its predecessor, the 2001 National Cholesterol Education Program Adult Treatment Panel III recommendation, according to a retrospective study published online Aug. 25 in the Journal of the American College of Cardiology. Read More>
    • How Much? Some Generic Drug Prices Are Skyrocketing: Analysis; August 14, 2014 – Are generic drugs still the bargain that everyone thinks? A new analysis finds that half of all generic drugs sold through retailers became more expensive over the past 12 months.  Read More>

    340B News

    Recertification deadline for 340B drug pricing program nears – September 2, 2014- Hospitals participating in the 340B program provided $28.4 billion in uncompensated care in 2012. Perhaps the biggest critics of the 340B program are large pharmaceutical companies that don’t reap financial benefits from providing discounted drugs. However, it’s notable that 340B drugs represent only two percent of a $300 billion big pharma market. These drugs represent a very low percentage of overall pharmaceutical profits. Discounting these drugs makes a significant difference for providers without gouging profits for drug manufacturers.  Read More>

    Fortifying the integrity of hospitals’ 340B programs – September, 1 2014 – Over the past few years, the 340B Drug Pricing Program has received increased scrutiny from Congress and the pharmaceutical industry. The Health Resources and Services Administration (HRSA) recently announced a renewed focus on making sure participants in the 340B program are adhering to specified policies and rules by conducting audits of covered entities. “Audits allow HRSA and all stakeholders the opportunity to improve oversight, monitor for potential violations, prevent and detect diversions of the discount, and most importantly, share information and create compliance,” said CDR Krista Pedley, PharmD, MS, Director of the HRSA Office of Pharmacy Affairs. Read More>  

    The case for drug discounts – August 28, 2014 – It is truly disappointing to see Howard Dean carrying the water for the pharmaceutical industry in his August 6op-ed, “How drug discounts are being manipulated.” His position on the vital 340B drug discount program is both misleading and at odds with his own track record of supporting universal healthcare.  Read More>

    Growth of 340B Triggers Battle Over Big Money – August 25, 2014 – The 340B Drug Pricing Program makes life-saving treatments available to low-income, uninsured and underinsured patients at extreme discounts. Proponents contend the program — created as part of the 1992 Public Health Service Act — greatly improved access to comprehensive cancer care.  Read More>