RxStrategies Clinical Insights – January 2015, Issue 1

    Welcome to the January edition of 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

    Savaysa™ (edoxaban tablets)
    January 8, 2015 — The U.S. Food and Drug Administration approved the anti-clotting drug Savaysa™ (edoxaban tablets) to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem. Savaysa™ also has been approved to treat deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients who have already been treated with an anti-clotting drug administered by injection or infusion (parenterally), for five to ten days. Read more.

    Saxenda® (liraglutide [rDNA origin] injection)
    December 23, 2014 — The U.S. Food and Drug Administration approved Saxenda® (liraglutide [rDNA origin] injection) as a treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity. The drug is approved for use in adults with a body mass index (BMI) of 30 or greater (obesity) or adults with a BMI of 27 or greater (overweight) who have at least one weight-related condition, such as hypertension, type 2 diabetes, or high cholesterol (dyslipidemia). Read more.

    Opdivo® (nivolimab)
    December 22, 2014 — The U.S. Food and Drug Administration granted accelerated approval to Opdivo® (nivolumab), a new treatment for patients with unresectable (cannot be removed by surgery) or metastatic (advanced) melanoma who no longer respond to other drugs. Opdivo® works by inhibiting the PD-1 protein on cells, which blocks the body’s immune system from attacking melanoma tumors. Opdivo® is intended for patients who have been previously treated with ipilimumab (Yervoy®) and, for melanoma patients whose tumors express a gene mutation called BRAF V600, for use after treatment with ipilimumab (Yervoy®) and a BRAF inhibitor. RxS Clinical Insight: Opdivo® has been approved with Orphan status. Read more.

    Rapivab™ (peramivir)
    December 22, 2014 — On December 19, the U.S. Food and Drug Administration approved Rapivab™ (peramivir) to treat influenza infection in adults. Influenza, commonly known as the flu, is a contagious respiratory illness caused by influenza viruses. Rapivab™ is an inhibitor of influenza virus neuraminidase, an enzyme that releases viral particles from infected cells. Neuraminidase inhibitors are commonly used to treat flu infection. Rapivab™ is the first neuraminidase inhibitor approved for intravenous (IV) administration and is administered as a single IV dose. It is intended for patients 18 years and older who have acute uncomplicated influenza and have shown symptoms of flu for no more than two days. Read more.

    Zerbaxa™ (ceftolozane/tazobactam)
    December 19, 2014 — The U.S. Food and Drug Administration approved Zerbaxa™ (ceftolozane/tazobactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI). Zerbaxa™ is a combination product containing ceftolozane, a cephalosporin antibacterial drug, and tazobactam, a beta-lactamase inhibitor. Zerbaxa™ is used to treat cUTI, including kidney infection (pyelonephritis). It is used in combination with metronidazole to treat cIAI. Read more.

    Lynparza™ (olaparib)
    December 19, 2014 — The U.S. Food and Drug Administration granted accelerated approval to Lynparza™ (olaparib), a new drug treatment for women with advanced ovarian cancer associated with defective BRCA genes, as detected by an FDA-approved test. Lynparza™ is a poly ADP-ribose polymerase (PARP) inhibitor that blocks enzymes involved in repairing damaged DNA. It is intended for women with heavily pretreated ovarian cancer that is associated with defective BRCA genes. RxS Clinical Insight: Lynparza® has been approved with Orphan status. Read more.

    Viekira Pak™ (ombitasvir, paritaprevir, ritonavir tablets co-packaged with dasabuvir tablets)
    December 19, 2014 — The U.S. Food and Drug Administration approved Viekira Pak™ (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis. Viekira Pak™ contains three new drugs—ombitasvir, paritaprevir and dasabuvir—that work together to inhibit the growth of HCV. It also contains ritonavir, a previously approved drug, which is used to increase blood levels of paritaprevir. Viekira Pak™ can be used with or without ribavirin, but it is not recommended for patients whose liver is unable to function properly (decompensated cirrhosis). Read more.

    Xtoro™ (finafloxacin otic suspension)
    December 17, 2014 — The U.S. Food and Drug Administration approved Xtoro™ (finafloxacin otic suspension), a new drug used to treat acute otitis externa, commonly known as swimmer’s ear. Xtoro™ is an eardrop approved to treat acute otitis externa caused by Pseudomonas aeruginosa and Staphylococcus aureus. Xtoro™ is the newest drug belonging to the fluoroquinolone antimicrobial drug class to be approved by the FDA. Read more.


    New Drug Formulations

    Duopa™ (carbidopa and levodopa)
    January 12, 2015 — The U.S. Food and Drug Administration (FDA) has approved AbbVie’s Duopa™ (carbidopa and levodopa) enteral suspension for the treatment of motor fluctuations for people with advanced Parkinson’s disease. Duopa™ is administered using a small, portable infusion pump that delivers carbidopa and levodopa directly into the small intestine for 16 continuous hours via a procedurally-placed tube. RxS Clinical Insight: Duopa™ has been approved with Orphan status. Read more.

    RYTARY™ (carbidopa and levodopa) extended-release capsules
    January 8, 2015 — Impax Pharmaceuticals, a division of Impax Laboratories, Inc., announced that the U.S. Food and Drug Administration (FDA) approved RYTARY, an extended-release oral capsule formulation of carbidopa-levodopa, for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication and/or manganese intoxication. Read more.

    Dyloject™ (diclofenac sodium) Injection
    December 30, 2014 — Hospira, Inc., the world’s leading provider of injectable drugs and infusion technologies, and a global leader in biosimilars, has received approval from the U.S. Food and Drug Administration (FDA) for Dyloject™ (diclofenac sodium) Injection, a proprietary nonsteroidal anti-inflammatory drug (NSAID) analgesic. Dyloject™ is indicated for use in adults for the management of mild to moderate pain and for the management of moderate to severe pain alone or in combination with opioid analgesics. Read more.

    Namzaric™ (memantine hydrochloride extended-release and donepezil hydrochloride)
    December 23, 2014 — Actavis and Adamas Pharmaceuticals Inc. announced the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Namzaric™, a fixed-dose combination (FDC) of memantine hydrochloride extended-release, a NMDA receptor antagonist, and donepezil hydrochloride, an acetylcholinesterase inhibitor. Namzaric™ was approved for the treatment of moderate to severe dementia, of the Alzheimer’s type, in patients stabilized on memantine hydrochloride and donepezil hydrochloride. Read more.

    Soolantra® (ivermectin) Cream
    December 23, 2014 — Galderma Laboratories, L.P. announced the U.S. Food and Drug Administration (FDA) approved Soolantra® (ivermectin) Cream, 1% for the once-daily topical treatment of inflammatory lesions, or bumps and pimples, of rosacea. Read more.

    Signifor® LAR (pasireotide)
    December 16, 2014 — Novartis announced the US Food and Drug Administration (FDA) approved Signifor® long-acting release (LAR) (pasireotide) for injectable suspension, for intramuscular use, for the treatment of patients with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. The approval of Signifor® LAR, a next-generation somatostatin analog (SSA), helps address a critical unmet need among the acromegaly patient population. Signifor® LAR has been studied and found effective in both medically naïve patients with acromegaly who have had prior surgery or for whom surgery was not an option, as well as patients whose disease is not fully controlled on first generation SSAs. Read more.


    New Drug Indications

    Kalydeco® (ivacaftor)
    December 29, 2014 — Vertex Pharmaceuticals Incorporated announced the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) for the use of Kalydeco® (ivacaftor) in people with cystic fibrosis (CF), ages 6 and older, who have the R117H mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Read more.

    Granix® (tbo-filgrastim) Injection
    December 23, 2014 — Teva Pharmaceutical Industries Ltd. today announced the U.S. Food and Drug Administration (FDA) has approved Granix® (tbo-filgrastim) Injection for self-administration by patients and caregivers. With the approval of this additional administration option, physicians will soon have the flexibility to prescribe Granix® for either in-office or at home use. Read more.


    New Drug Shortages

    January 15, 2015
    Fluoxymesterone (Androxy) Tablets, USP (Currently in Shortage)

    January 9, 2015
    Gentamicin Sulfate Injection, USP (premix products) (Discontinuation)

    January 8, 2015
    Dimercaprol (Bal-in-Oil) Injection (Currently in Shortage)

    January 6, 2015
    Imipenem and Cilastatin for Injection (Primaxin I.V. ADD-Vantage) (Discontinuation)

    December 23, 2014
    Quazepam (Doral) Tablets (Currently in Shortage)


    New Generic Drugs

    Clobetasol propionate spray (Clobex® Spray)
    January 12, 2015 — Perrigo Company plc announced it has launched clobetasol propionate spray, 0.05%, the generic equivalent to Clobex® Spray, 0.05%. Perrigo was the first generic filer against this product and it is entitled to 180 days of generic exclusivity. The launch date was agreed upon in a litigation settlement between Perrigo and Galderma Laboratories, L.P. Read more.

    Estradiol Transdermal System (Vivelle-DOT®)
    December 22, 2014 — Mylan Inc. announced the U.S. launch of its Estradiol Transdermal System USP, 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day (twice weekly), which is the generic version of Novartis’ Vivelle-DOT®. Read more.


    New Product Recall 

    December 23, 2014 — Hospira, Inc. announced it has initiated a worldwide voluntary recall to the user level of 10 lots of MitoXANTRONE (both human and veterinary), due to confirmed sub potency and elevated impurity levels. Risk factors associated with these types of out of specifications may include the potential for decreased potency, which can lead to decreased effectiveness, additional dosing and the potential for cumulative impurity toxicity requiring medical intervention. Read more.

    Virazole (Ribavirin Powder for Solution) by Valeant Pharmaceutical North America, LLC: Recall– Due to Microbial Contamination
    January 2, 2015 — Valeant Pharmaceuticals North America LLC (VPNA) issued a voluntarily recall of one lot of Virazole (ribavirin powder for solution), 100 mL, 6g Vial, 4-pack, to the user level. Inhalation of a non-sterile product with microbial contamination into the airways could increase the risk of respiratory infection. The risk is higher in patients who are immunocompromised (because of underlying disease), and are more susceptible. Read more.


    Drug Safety Alerts

    Prescription and Over-the-Counter (OTC) Pain Medicines: Drug Safety Communication – FDA Review of Possible Risks of Pain Medicine Use During Pregnancy
    January 9, 2015 — The FDA is aware of and understands the concerns arising from recent reports questioning the safety of prescription and over-the-counter (OTC) pain medicines when used during pregnancy. As a result, the FDA evaluated research studies published in the medical literature and determined they are too limited to make any recommendations based on these studies at this time. Because of this uncertainty, the use of pain medicines during pregnancy should be carefully considered. The FDA urges pregnant women to always discuss all medicines with their health care professionals before using them. Read more.


    Clinical and Pharmacy News 

    What’s the True Cost of Exclusive Drug Deals?
    January 17, 2015 — In the past several weeks, Express Scripts and CVS Healthcare have announced exclusivity deals with AbbVie and Gilead, respectively, for their hepatitis C medications. The agreements offer access to the extremely costly medications that have been previously denied formulary inclusion by these massive PBMs. Read more.

    Provider Status: What It Means to Pharmacy Practice
    January 15, 2015 — Pharmacists have extensive specialized education and training in the use of medications to treat, manage and prevent disease, as well as decrease the incidents of adverse drug reactions and interactions. When pharmacists are involved members of the health care team, costs are reduced and patient outcomes are improved. Read more.

    CDC: Some Hospital Super Bugs Losing Their Power
    January 15, 2015 — Overall health care–associated (HCA) infections in acute care hospitals have decreased nationally, including a 10% decrease in Clostridium difficile infections and an 8% decrease in methicillin resistant Staphylococcus aureus (MRSA) bacteremia between 2012 and 2013, according to a new report. Read more.

    Why Drugs Cost so Much
    January 14, 2015 — Eli Lilly charges more than $13,000 a month for Cyramza, the newest drug to treat stomach cancer. The latest medicine for lung cancer, Novartis’s Zykadia, costs almost $14,000 a month. Amgen’s Blincyto, for leukemia, will cost $64,000 a month. Why? Drug manufacturers blame high prices on the complexity of biology, government regulations and shareholder expectations for high profit margins. In other words, they say they are hamstrung. But there’s a simpler explanation. Read more.

    American Pharmacists Association Launches New PharmacistsProvideCare.com Website
    January 14, 2015 — This week, the American Pharmacists Association launched the new and improved PharmacistsProvideCare.com, APhA’s website dedicated to the “Pharmacists Provide Care” campaign for pharmacists’ provider status and the promotion of patient access to and coverage of pharmacists’ patient care services. PharmacistsProvideCare.com is a resource for patients and policymakers who want to learn more about the recognition of pharmacists and their services. Additionally, the website provides information for pharmacists to help them get engaged and involved in this important campaign. Read more.

    The New Guidelines for Prophylactic Antibiotic Use Are Finally Here
    January 14, 2015 — This article will review the highlights of the report, “The use of prophylactic antibiotics prior to dental procedures in patients with prosthetic joints,” but you’re encouraged to read the entire ADA report. Nearly one million total hip replacements or total knee replacements are performed in the United States each year. It is estimated that by 2030, more than four million hip and knee replacements will be performed annually in the U.S. In a retrospective study evaluating 462 cases of prosthetic hip or knee infection, the major risk factor associated with infection was superficial surgical site infection. Prosthetic joint infection occurs in 1% to 2% of joint replacement surgeries and is one of the leading causes of arthroplasty failure. Read more.

    CVS Health Research Institute Provides More Evidence that Broader Prescription Drug Coverage Improves Health Outcomes
    January 13, 2015 — A new analysis by researchers at Brigham and Women’s Hospital and the CVS Health (NYSE: CVS) Research Institute, published online first in the American Journal of Public Health, shows that enhanced prescription drug insurance can improve patient health outcomes and reduce use of other, often costly, health care services. Read more.

    ASCO Calls for Medicaid Reform to Improve Cancer Care for Beneficiaries
    January 13, 2015 — State Medicaid programs must strengthen and expand access to high-quality cancer care for patients with low incomes, according to a new policy statement from the American Society of Clinical Oncology (ASCO). About a fifth of the U.S. population, or 67.9 million individuals, is enrolled in Medicaid, and an estimated 2.1 million of them either have cancer or have previously been treated for it, according to the ASCO statement. Read more.

    As Biotech Booms, High Drug Costs Cause Worry
    January 12, 2015 — These are boom times for biotechnology. Forty-one new drugs were approved for U.S. sale in 2014, the biggest number in 18 years. A record 63 biotech startups went public, breaking the 1999 record of 52 initial public offerings. The value of biopharma merger deals nearly tripled to $223 billion from a year earlier. Read more.

    The Role of Retail Pharmacies in CVD Prevention after the Release of the ATP IV Guidelines
    January 8, 2015 — November 2013 marked the release of the much-awaited National Cholesterol Education Program Adult Treatment Panel IV (ATP IV) guidelines for cholesterol management, which sent shockwaves throughout the health care system. The guidelines fundamentally altered long-held conceptions about how to best manage hypercholesterolemia in order to reduce cardiovascular risk. The effectiveness and safety of statins had not been in question as the cornerstone of therapy. However, we had always been advised to start at a low dose and to treat to specific low-density lipoprotein (LDL) targets, intensifying therapy incrementally until those targets were met. Read more.

    FDA Panel Recommends Approval for First Generic Biotech Drug
    January 7, 2015 — Generic biotech drugs took one step closer to reality after a Food and Drug Administration advisory panel recommended the agency approve a Novartis AG version of Amgen’s Inc.’s drug Neupogen, according to media reports. In a 14-0 vote, the panel agreed with FDA staff that Novartis’s Zarxio was “highly similar” to Neupogen, which is used to treat infections during chemotherapy. Read more.

    Bronchiolitis Guidelines: Diagnosis, Management and Prevention
    January 1, 2015 — Updated clinical practice guidelines by the American Academy of Pediatrics provide new recommendations that emphasize supportive care and select use of prophylactic palivizumab. Read more.

    A Tale of Two Health Systems: New Care Models Showcase Pharmacists’ Skills across the Continuum of Care
    January 1, 2015 — The hospital pharmacist’s role in transitions of care is one of the hottest topics in health-system pharmacy. It is an area in which clinical pharmacists are uniquely qualified to help patients at every point along the health care continuum, from hospital admission to discharge to follow-up care in the community or home setting. Two health systems on the east coast have developed innovative transitions of care programs that include hospital pharmacists, community pharmacists and clinical pharmacists as part of the primary care health team. Read more.

    A Prescription for Better Health and Cost Savings
    December 23, 2014 — Business-driven analytics and integrated patient insights provide information and opportunities for retail pharmacies and other community health care organizations to better understand their customers and improve quality of care. With the right tools and data, these companies can deliver better outcomes for patients and contain escalating costs. Read more.

    New PBM Transparency Bill Covers More Federal Programs
    December 23, 2014 — A bill to make pharmacy benefit managers’ reimbursements for generic drugs more transparent will cover more federal health care programs than a bill introduced earlier this year. Representative Doug Collins (R-GA) and Representative Dave Loebsack (D-Iowa) introduced both bills. The earlier bill applied only to Medicare Part D; however, the new bill will also cover the military’s TRICARE program and the Federal Employees Health Benefits Program. The earlier bill, called the Generic Drug Pricing Transparency Act, introduced in April, would clarify the process used to determine Maximum Allowable Cost lists, the timing of updates to the lists, and the appeals process for disputes over payment levels. It would also force pharmacy benefit managers to disclose deceptive practices used to generate profit. Read more.


    340B News

    340B Program Demands Compliance; Are You Ready?
    January 14, 2014Given the complex requirements of the federal 340B Drug Pricing Program, chief pharmacy officers and other stakeholders need to dedicate resources to manage its complex components, according to Christopher A. Hatwig, the president of Apexus, the prime vendor for 340B participants. Read more.

    My View: Drug Manufacturers Not Truthful about Discount Program
    December 27, 2014 – I wish I could say David Miller’s piece, “My View: Hospitals abuse drug program meant to help poor,” (Rockford Register Star) presents new arguments. Sadly, it’s just more of the same tired and deceptive messaging from the bio/pharmaceutical industry. Why do drug companies dislike the 340B drug discount program so much? Because they hate selling medicines at a reduced profit to health providers that treat high numbers of poor people—despite the good it does in Illinois and across the country. Read more.