Welcome to the February/March 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
February 25, 2015 — The U.S. Food and Drug Administration approved Avycaz (ceftazidime-avibactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including kidney infections (pyelonephritis), who have limited or no alternative treatment options. Read more.
February 23, 2015 — U.S. Food and Drug Administration granted accelerated approval to panobinostat (Farydak capsules, Novartis Pharmaceuticals) in combination with bortezomib and dexamethasone for the treatment of patients with multiple myeloma, who have received at least two prior regimens, including bortezomib and an immunomodulatory agent. As a condition of this accelerated approval, FDA requires the sponsor to conduct a trial to verify and describe the clinical benefit of panobinostat for patients with multiple myeloma. Read more.
February, 13 2015 — The U.S. Food and Drug Administration approved Lenvima™ (lenvatinib) to treat patients with progressive, differentiated thyroid cancer (DTC) whose disease progressed despite receiving radioactive iodine therapy (radioactive iodine refractory disease). The most common type of thyroid cancer, DTC is a cancerous growth of the thyroid gland, which is located in the neck and helps regulate the body’s metabolism. The National Cancer Institute estimates that 62,980 Americans were diagnosed with thyroid cancer and 1,890 died from the disease in 2014. Lenvima™ is a kinase inhibitor, which works by blocking certain proteins from helping cancer cells grow and divide. Read more.
February 3, 2015 — The U.S. Food and Drug Administration granted accelerated approval to Ibrance® (palbociclib) to treat advanced (metastatic) breast cancer. Ibrance® works by inhibiting molecules, known as cyclin-dependent kinases (CDKs) 4 and 6, involved in promoting the growth of cancer cells. Ibrance® is intended for postmenopausal women with estrogen receptor (ER)—positive, human epidermal growth factor receptor 2 (HER2)—negative metastatic breast cancer, who have not yet received an endocrine-based therapy. It is to be used in combination with letrozole, another FDA-approved product used to treat certain kinds of breast cancer in postmenopausal women. Read more.
Natpara® (parathyroid hormone)
January 23, 2015 – The U.S. Food and Drug Administration approved Natpara® (parathyroid horomone) to control hypocalcemia (low blood calcium levels) in patients with hypoparathyroidism, a rare disease that affects approximately 60,000 people in the United States. Hypoparathyroidism occurs when the body secretes abnormally low levels of parathyroid hormone, which helps regulate calcium and phosphorus levels in the body. Read more.
Triferic™ (ferric pyrophosphate citrate)
January 23, 2015 — Rockwell Medical, Inc. announced the U.S. Food & Drug Administration has approved its drug Triferic™ for commercial sale as an iron replacement product to maintain hemoglobin in adult patients with hemodialysis dependent chronic kidney disease. Triferic™ provides innovative iron drug delivered via dialysate, replaces dialytic iron loss and maintains hemoglobin concentration without increasing iron stores. Read more.
Bexsero® (meningococcal group B vaccine)
January 23, 2015 — The U.S. Food and Drug Administration approved Bexsero®, a vaccine to prevent invasive meningococcal disease caused by Neisseria meningitides serogroup B in individuals 10 through 25 years of age. Bexsero® is the second vaccine approved by the FDA in the past three months to prevent this disease. The agency approved the first meningococcal serogroup B vaccine (Trumenba®) in October 2014. Before these approvals, existing approved meningococcal vaccines in the U.S. covered only four of the five main serogroups of N. meningitidis bacteria that cause meningococcal disease: A, C, Y and W. Read more.
January 21, 2015 — The U.S. Food and Drug Administration approved Cosentyx™ (secukinumab) to treat adults with moderate-to-severe plaque psoriasis. Secukinumab is an antibody that binds to a protein (interleukin (IL)-17A), which is involved in inflammation. By binding to IL-17A, secukinumab prevents it from binding to its receptor, and inhibits its ability to trigger the inflammatory response that plays a role in the development of plaque psoriasis. Read more.
Phoxillum (renal replacement solution)
January 20, 2015 — Baxter International Inc. announced the U.S. Food and Drug Administration has approved Phoxillum Renal Replacement Solutions (BK4/2.5 and B22K4/0) as replacement solutions in continuous renal replacement therapy (CRRT) to correct electrolyte and acid-base imbalances, and in case of drug poisoning when CRRT is used, to remove dialyzable substances. Read more.
New Drug Formulation
Liletta™ (levonorgestrel-releasing intrauterine system)
February 27, 2015 — Actavis plc and Medicines360 announced the approval of Liletta™ (levonorgestrel-releasing intrauterine system) by the U.S. Food and Drug Administration (FDA) for use by women to prevent pregnancy for up to three years. Liletta™ is placed in the uterus by a health care professional and works by continuously releasing levonorgestrel, a progestin, to prevent pregnancy. Read more.
Minivelle® (estradiol transdermal system) — New Dosage Strength
February 12, 2015 — Noven Pharmaceuticals, Inc. announced the new 0.025 mg/day dosage strength for Minivelle® (estradiol transdermal system) is now available by prescription nationwide for only the prevention of postmenopausal osteoporosis. The FDA initially approved Minivelle® in October 2012 to treat moderate to severe vasomotor symptoms (VMS) due to menopause, commonly known as hot flashes. In September 2014, the FDA approved a new indication for prevention of postmenopausal osteoporosis for all doses of Minivelle®. The new 0.025 mg/day low dose was approved for this indication only. Read more.
Dutrebis™ (lamivudine and raltegravir)
February 6, 2015 — U.S. Food and Drug Administration approved Dutrebis™, a fixed dose combination tablet containing 150 mg of lamivudine and 300 mg of raltegravir. Dutrebis™ tablet is approved for use in combination with other antiretroviral products for the treatment of HIV-1 infection in adults and pediatric patients greater than or equal to 6 years of age, weighing at least 30 kg. The recommended dosage of Dutrebis is one tablet taken twice daily with or without food. According to the manufacturer, Merck Pharmaceuticals, Dutrebis will not be made commercially available in the U.S. at this time. Read more.
Zohydro ER® (hydrocodone bitartrate extended-release)
January 30, 2015 — The FDA has approved a new formulation of Zohydro® ER (hydrocodone bitartrate) extended-release capsules. The new formulation contains abuse-deterrent properties using the proprietary technology BeadTek. Zohydro® ER is indicated for patients with severe pain that requires daily, around-the-clock, long-term opioid treatment and in cases where other treatment options are inadequate. It will be available in the second quarter of 2015 in dosage strengths from 10 to 50 mg. Zohydro® ER does not contain acetaminophen and is to be taken every 12 hours. Read more.
Glyxambi® (empagliflozin and linagliptin)
January 30, 2015 — The U.S. Food and Drug Administration has approved Glyxambi® (empagliflozin/linagliptin) tablets, from Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (T2D), when both empagliflozin (Jardance®) and linagliptin (Tradjenta®) are appropriate treatments. Read more.
Pazeo™ (olopatadine hydrochloride ophthalmic solution)
January 30, 2015 — Alcon, a division of Novartis, received approval from the U.S. Food and Drug Administration for Pazeo™ (olopatadine hydrochloride ophthalmic solution) 0.7%, for the treatment of ocular itching associated with allergic conjunctivitis. Pazeo™ solution is dosed one drop daily, and was approved with efficacy data at 24 hours, post dose. Read more.
Prezcobix™ (cobicistat and darunavir)
January 29, 2015 — Janssen Therapeutics, Division of Janssen Products, LP (Janssen) announced the U.S. Food and Drug Administration approved Prezcobix™ (darunavir 800 mg/cobicistat 150 mg) tablets, an HIV-1 protease inhibitor combined with a CYP3A4 inhibitor, for the treatment of human immunodeficiency virus (HIV-1), in combination with other antiretroviral agents for treatment-naive and treatment-experienced adults, with no darunavir resistance-associated substitutions. Prezcobix™ is a once-daily, fixed-dose antiretroviral combination tablet containing 800 mg of darunavir, marketed as Prezista® in the United States, and 150 mg of cobicistat, a pharmacokinetic enhancer or “boosting” agent, developed and marketed as Tybost® by Gilead Sciences, Inc., taken orally with other HIV-1 medications and with food. Read more.
Evotaz™ (atazanavir and cobicistat)
January 29, 2015 — Bristol-Myers Squibb Company announced the U.S. Food and Drug Administration has approved Evotaz™ (atazanavir 300 mg and cobicistat 150 mg) tablets in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. Evotaz™ is coformulated to be one pill, once-daily, combining the protease inhibitor atazanavir, which is marketed as Reyataz® (atazanavir 200 mg/300 mg) capsules, and cobicistat (Tybost®), a pharmacokinetic enhancer marketed by Gilead Sciences, Inc. Read more.
Prestalia® (amlodipine besylate and perindopril arginine)
January 26, 2015 — Symplmed Pharmaceuticals announced the U.S. Food and Drug Administration has approved Prestalia® (perindopril arginine and amlodipine) tablets for the treatment of hypertension. Prestalia®, the first fixed-dose combination of these two medications (ACE inhibitors and calcium channel blocker), may be used in patients whose blood pressure is not adequately controlled on monotherapy. Read more.
New Drug Indication
February 18, 2015 — Celgene Corporation announced the U.S. Food and Drug Administration has expanded the existing indication for Revlimid® (lenalidomide), in combination with dexamethasone, to include patients newly diagnosed with multiple myeloma (NDMM). Revlimid®, plus dexamethasone, was previously approved in June 2006 for use in multiple myeloma patients, who have received at least one prior therapy. Read more.
February 16, 2015 — Eisai Co., Ltd. announced its U.S. subsidiary Eisai Inc. has received approval of an additional pediatric indication for Eisai’s antiepileptic drug (AED) Banzel® (rufinamide) from the U.S. Food and Drug Administration (FDA). Through this approval, Banzel®, which had been approved for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children four years older and adults, is now additionally approved for the same indication in pediatric patients from one to less than four years of age in the United States. Read more.
Lucentis® (ranibizumab injection)
February 6, 2015 — Genentech announced the U.S. Food and Drug Administration approved Lucentis® (ranibizumab injection) for the treatment of diabetic retinopathy (DR) in people with diabetic macular edema (DME). DME impacts nearly 750,000 Americans, about 10 percent of people with DR. Read more.
Vyvanse® (lisdexamfetamine dimesylate)
January 30, 2015 — The U.S. Food and Drug Administration expanded the approved uses of Vyvanse® (lisdexamfetamine dimesylate) to treat binge-eating disorder in adults. The drug is the first FDA-approved medication to treat this condition. Read more.
January 29, 2015 — The U. S. Food and Drug Administration approved Imbruvica® (ibrutinib) for the treatment of patients with Waldenstrom’s macroglobulinemia (WM). Imbruvica® was initially approved in November 2013 for the treatment of patients with mantle cell lymphoma (MCL), who have received at least one prior therapy. Imbruvica® also received approval in February 2014 for the treatment of chronic lymphocytic leukemia (CLL) in patients who received at least one prior therapy and in July 2014 for the treatment of CLL with 17p deletion. Read more.
New Drug Shortage
February 27, 2015
• Magnesium Sulfate Injection (Currently in Shortage)
February 23, 2015
• Clonidine HCL Injection (Duraclon) (Resolved)
February 17, 2015
• Cefotaxime Sodium (Claforan) Injection (Currently in Shortage)
February 05, 2015
• Gentamicin Sulfate Injection, USP (premix products) (Discontinuation)
• Ketorolac Tromethamine Injection (Currently in Shortage)
January 23, 2015
• Nebivolol (BYSTOLIC) Tablets (Currently in Shortage)
January 22, 2015
• Tobramycin Injection (Currently in Shortage)
January 20, 2015
• Boceprevir (VICTRELIS) Capsules (Discontinuation)
New Generic Drug
Nexium® (esomeprazole magnesium delayed-release capsules)
January 26, 2015 — The U.S. Food and Drug Administration approved the first generic version of Nexium® (esomeprazole magnesium delayed-release capsules) to treat gastroesophageal reflux disease (GERD) in adults and children ages 1 and older. Esomeprazole is a proton pump inhibitor that reduces the amount of acid in the stomach. Ivax Pharmaceuticals, Inc., a subsidiary of Teva Pharmaceuticals USA, has gained approval to market esomeprazole in 20 and 40 milligram capsules. Read more.
Lamictal® ODT (lamotrigine orally disintegrating tablets)
January 26, 2015 — Impax Laboratories, Inc. announced the U.S. Food and Drug Administration (FDA) has approved generic Lamictal® (lamotrigine orally disintegrating tablets,) 25mg, 50mg, 100mg and 200mg, in blister packaging. Impax will promptly initiate commercialization of this product through Global Pharmaceuticals, Impax’s generic division. In July 2014, Impax acquired from Actavis plc the approved Abbreviated New Drug Application (ANDA) for generic lamotrigine ODT packaged in bottles pursuant to an Asset Purchase Agreement with Actavis. Impax believes its ANDA was the first substantially complete ANDA with a paragraph IV certification and expects to be entitled to 180 days of market exclusivity. Read more.
Drug Safety Alerts
Colistimethate for Injection USP, 150 mg, and Rifampin for Injection USP, 600 mg/vial, by Heritage Pharmaceuticals: Recall – Lack of Sterility Assurance
February 25, 2015 — Heritage Pharmaceuticals Inc. announced the voluntary nationwide recall of ten (10) lots of Colistimethate for Injection, USP, 150 mg Single-Dose vial (NDC 23155-193-31) and three (3) lots of Rifampin for Injection, USP, 600 mg Single-Dose vial (NDC 23155-340-31) manufactured by Emcure Pharmaceuticals Ltd. and distributed by Heritage. Heritage has initiated this voluntary recall to the user level, due to FDA observations pertaining to aseptic and GMP practices at the manufacturer’s site potentially impacting product sterility. Read more.
Atracurium Besylate Injection by Sagent Pharmaceuticals: Recall – Product Sterility
February 24, 2015 — Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of two lots of Atracurium Besylate Injection, USP, 50mg/5mL single-dose vials (NDC 25021-659-05) and four lots of Atracurium Besylate Injection, USP, 100mg/10mL multi-dose vials (NDC 25021-672-10) manufactured by Emcure Pharmaceuticals Ltd. and distributed by Sagent. Read more.
Ketorolac Tromethamine Injection by Hospira: Particulate in Glass Vials –Product Recall
February 11, 2015 — Hospira announced a voluntary recall of ketorolac tromethamine injection, USP in the United States and Singapore due to potential particulate. The presence of particulate has been confirmed through a customer report of visible, floating particulate identified in glass fliptop vials. The particulate was identified as calcium-ketorolac crystals. If particulates are not observed prior to administration, intramuscular (IM) or intravenous (IV) administration theoretically could result in localized inflammation, allergic reaction, granuloma formation or micro embolic effects (IV only). Read more.
0.9 Percent Sodium Chloride Injection, USP, 250 mL by Hospira: Recall – Particulate Matter
January 23, 2015 — Hospira, Inc. announced a voluntary nationwide recall of one lot of 0.9% Sodium Chloride Injection, USP, 250 mL (NDC 0409-7983-02, Lot 44-002-JT, Expiry 1AUG2016), to the user level, due to one confirmed customer report of particulate in a single unit. Hospira has identified the particulate as a human hair, sealed in the bag at the additive port area. To date, Hospira has not received reports of any adverse events associated with this issue for this lot. Read more.
Clinical and Pharmacy News
An Inside Job: Hospital Adds $1.6 Million in Billables Via MTM
February 19, 2015 — An Oregon hospital has demonstrated that inpatient medication therapy management (MTM)—traditionally thought of as an outpatient pharmacy service—is financially lucrative, as well as a boon to clinical pharmacists. The project’s researchers said the success of their inpatient MTM service nearly doubled the number of clinical consultations they conducted over a four-year period and generated approximately $1.6 million in billable pharmacy services in 2014. Read more.
Pharmacy Deserts: Another Way Your Address May Affect Your Health
February 19, 2015 — You may have heard of food deserts—communities that lack access to fresh produce and other healthy foods. Now researchers in Chicago have found another type of desert, one that could play a similarly significant role in U.S. health disparities. Pharmacy deserts are communities without access to nearby drugstores. Residents in these areas have to travel much farther than others to get prescriptions filled, buy over-the-counter medications or visit the growing number of urgent care clinics found inside stores. Read more.
FDA Releases Draft Documents on Compounding, Repackaging
February 17, 2015 — The FDA has released five draft guidance documents related to drug compounding and repackaging that aim to help pharmacies, federal facilities, outsourcing facilities and physicians comply with important public health provisions. The new category of outsourcing facilities was created under the Drug Quality and Security Act (DQSA), enacted by Congress in November 2013 in response to a deadly fungal meningitis outbreak that was linked to contaminated sterile compounded drug products. Read more.
Specialty Medications Have PBMs on Edge
February 17, 2015 — The HCV price war, which seemed to dominate the summer drug conversation, looked as though it was going to be superseded by new worry over the price of cancer medications. A Health Affairs blog post by execs at CVS Health, however, indicates that these fights are part of a much larger issue: the anticipated watershed in the specialty medication category itself. Read more.
Fighting for Fair PBM Auditing Practices, State by State
February 13, 2015 — Many instances of abuse’; minor clerical errors often targeted. PBM audits were happening so frequently at the five community pharmacies operated in Ohio by John Coler, BSPharm, that two staff members were assigned the task of digging through them. The problem was that the large sums of money PBMs wanted were for minute errors like misspelling a person’s name. “We were getting audited for reasons that didn’t affect the patient, outcomes, or the payer in a negative way,” Coler told Pharmacy Today. “It was mostly clerical errors.” Read more.
FDA Seeks $4.9 Billion for FY 2016 to Implement the FDA Food Safety Modernization Act and Improve the Quality and Safety of the Medical Products Americans Use
February 10, 2015 — The U.S. Food and Drug Administration is requesting a budget of $4.9 billion to protect and promote public health as part of the President’s fiscal year (FY) 2016 budget—a nine percent increase over the enacted budget for FY 2015. The overall request includes $147.7 million in budget authority for initiatives tied to several key areas, including the implementation of the FDA Food Safety Modernization Act and the management of critical medical products issues. Read more.
CMS Oncology Care Model Names NCCN Guidelines as High-Quality Care and Evidence-Based Recommendations
February 12, 2015 — Centers for Medicare & Medicaid Services Innovation (CMS Innovation Center) announced an Oncology Care Model (OCM) with the goal to utilize appropriately aligned financial incentives to improve care coordination, appropriateness of care, and access to care for beneficiaries undergoing chemotherapy. To participate in the OCM, participating practices will be required to treat patients with therapies consistent with nationally recognized clinical practice guidelines, such as those published by the National Comprehensive Cancer Network® (NCCN®) and American Society of Clinical Oncology (ASCO), reporting both when patients are and are not treated in concordance with such recommendations. Read more.
New Dosage Strength Available for Teva’s Generic Focalin XR Caps
February 3, 2015 — Teva Pharmaceuticals on Tuesday announced the introduction of dexmethylphenidate hydrochloride extended-release capsules, CII, in 10-mg dosage strength. The drug is the generic equivalent to Focalin XR® from Novartis. Read more.
Guideline Clarifies First-Line Treatment for Allergic Rhinitis
February 2, 2015 — First-line treatment for allergic rhinitis should include intranasal steroids, as well as less-sedating second-generation oral antihistamines for patients whose primary complaints are sneezing and itching, according to a new clinical practice guideline published online Feb. 2 in Otolaryngology–Head and Neck Surgery. Read more.
Want to Control Drug Prices? Reject Price Controls.
January 26, 2015 — The past year has seen an epic confrontation pitting insurers and payers against drug companies. In the process, Sovaldi and, more recently, once-a-day interferon-free Harvoni Hepatitis C (HCV) treatments have become the new poster children for pharmaceutical companies profiteering off the sick. Priced at $84,000 and $94,500, respectively, the two HCV drugs drew stinging rebukes from pharmaceutical benefit managers (PBMs), patient groups and even the House Energy and Commerce Committee, in part because they were seen as breaking an unspoken rule. Read more.
Rx Trends 2015: Pharmacy-Based Diagnostic Screenings January 23, 2015 — Patient screenings and advanced, gene-based diagnostics may soon become a standard and universally accepted part of retail pharmacy’s service platform. The shrinking pool of overburdened family doctors is shifting more primary care services to pharmacists, just as the field of genomics explodes and rapid advances in diagnostic technology put cheap, easy-to-use screening tools into the hands of pharmacists. Read more.
New Guideline Released on Pharmacological Management of Obesity
January 23, 2015 — The Endocrine Society has released a clinical practice guideline on the pharmacological management of obesity that includes recommendations on strategies for prescribing weight loss drugs. Read more.
The American Headache Society Announces New Treatment Guidelines
January 21, 2015 — New guidelines are being set for assessing medications aimed at treating acute migraine onsets. This is to help ensure that patients get the proper care with the least amount of risk. Obviously, this involves the updating of the classification of pain medications used to treat migraine headaches, such as NSAIDs (nonsteroidal anti-inflammatory drugs), butorphanol nasal spray, triptans and others. Read more.
FDA Releases Draft Documents on Compounding, Repackaging
February 18, 2015 — The FDA has released five draft guidance documents related to drug compounding and repackaging that aim to help pharmacies, federal facilities, outsourcing facilities and physicians comply with important public health provisions. The new category of outsourcing facilities was created under the Drug Quality and Security Act (DQSA), enacted by Congress in November 2013 in response to a deadly fungal meningitis outbreak that was linked to contaminated sterile compounded drug products. Drugs compounded in an outsourcing facility that meet certain conditions may be entitled to exemptions from certain provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), including the new drug approval requirements and the requirement to label drug products with adequate directions for use. Read more.
Tomorrow’s 340B: Accountability, Growth and Transparency for the Covered Entity
February 2, 2105 — Reducing or eliminating 340B could cripple safety net providers across the country. Over the last two decades, Republicans and Democrats jointly supported legislation to expand 340B, the federal program that provides significant discounts on high cost, life-sustaining outpatient drugs to hospitals that serve a disproportionate share of low-income patients. Read more.
HHS Asks DC Court to Nix PhRMA’s 340B Orphan Drug Suit
January 28, 2015 — The U.S. Department of Health and Human Services asked a D.C. federal court to toss Pharmaceutical Research and Manufacturers of America’s complaint challenging a department rule on discounting so-called orphan drugs in the 340B program, saying the interpretive rule wasn’t subject to the court’s review. Read more.