RxStrategies Clinical Insights — November Issue 1

    Welcome to the first November 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

    Imlygic™ (talimogene laherparepvec)

    October 27, 2015 — The U.S. Food and Drug Administration approved Imlygic™ (talimogene laherparepvec), the first FDA-approved oncolytic virus therapy, for the treatment of melanoma lesions in the skin and lymph nodes. Imlygic™, a genetically modified live oncolytic herpes virus therapy, is used to treat melanoma lesions that cannot be removed completely by surgery. Imlygic™ is injected directly into the melanoma lesions, where it replicates inside cancer cells and causes the cells to rupture and die. Read more.


    Yondelis® (trabectedin)

    October 23, 2015 — The U.S. Food and Drug Administration approved Yondelis® (trabectedin), a chemotherapy, for the treatment of specific soft tissue sarcomas (STS)—liposarcoma and leiomyosarcoma—that cannot be removed by surgery (unresectable) or is advanced (metastatic). This treatment is approved for patients who previously received chemotherapy that contained anthracycline. Read more.


    Strensiq™ (asfotase alfa) Injection

    October 23, 2015 — The U.S. Food and Drug Administration approved Strensiq™ (asfotase alfa) as the first approved treatment for perinatal, infantile and juvenile-onset hypophosphatasia (HPP).  HPP is a rare, genetic, progressive, metabolic disease, in which patients experience devastating effects on multiple systems of the body, leading to severe disability and life-threatening complications. It is characterized by defective bone mineralization that can lead to rickets and softening of the bones that result in skeletal abnormalities. RxS Clinical Insight: Note Strensiq™ has orphan drug status. Read more.


    Veltassa™ (patiromer) for Oral Suspension

    October 21, 2015 — The U.S. Food and Drug Administration approved Veltassa™ (patiromer for oral suspension) to treat hyperkalemia, a serious condition in which the amount of potassium in the blood is too high. Potassium, a mineral that is delivered to the body by food, is needed for cells to function properly. The kidneys remove potassium from the blood to maintain a proper balance of potassium in the body. But when the kidneys are not able to remove enough potassium from the blood, the level of potassium can get too high. Read more.


    Coagadex® (coagulation factor X (human))

    October 20, 2015 — The U.S. Food and Drug Administration approved Coagadex®, Coagulation Factor X (Human), for hereditary Factor X (10) deficiency. Until today’s orphan drug approval, no specific coagulation factor replacement therapy was available for patients with hereditary Factor X deficiency. In healthy individuals, the Factor X protein activates enzymes to help with normal blood clotting in the body. Factor X deficiency is an inherited disorder, affecting men and women equally, where the blood does not clot as it should. Read more.


    Praxbind® (idarucizumab) Injection

    October 16, 2015 — The U.S. Food and Drug Administration granted accelerated approval to Praxbind® (idarucizumab), for use in patients who take the anticoagulant Pradaxa® (dabigatran) during emergency situations, when there is a need to reverse Pradaxa’s® blood-thinning effects. The FDA approved Pradaxa® in 2010 to prevent stroke and systemic blood clots in patients with atrial fibrillation, as well as for the treatment and prevention of deep venous thrombosis and pulmonary embolism. Read more.



    New Formulation Approval

    Belbuca™ (buprenorphine hydrochloride) Buccal Film

    October 26, 2015  — BioDelivery Sciences International, Inc. and its partner Endo Pharmaceuticals Inc. announced the U.S. Food and Drug Administration approved Belbuca™ (CIII) (buprenorphine HCl) buccal film, for use in patients with chronic pain that is severe enough to require daily, around-the-clock, long-term opioid treatment, for which alternative treatment options are inadequate. Read more.


    Onivyde™ (irinotecan liposomal) Injection

    October 22, 2015 — The U.S. Food and Drug Administration approved Onivyde (irinotecan liposome injection), in combination with fluorouracil and leucovorin, to treat patients with advanced (metastatic) pancreatic cancer, who have been previously treated with gemcitabine-based chemotherapy. Read more.


    Dyanavel™ XR (amphetamine) Extended-Release Oral Suspension

    October 20, 2015 — Tris Pharma, Inc. (“Tris”) announced the U.S. Food and Drug Administration approved Dyanavel™ XR (amphetamine), extended-release oral suspension, CII, for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children six years and older. With this approval, Dyanavel™ XR becomes the only once-daily, extended-release, amphetamine-based oral liquid approved for the treatment of ADHD in children. Read more.


    Enstilar® (betamethasone dipropionate and calcipotriene) Foam

    October 19, 2015 — LEO Pharma announced the U.S. Food and Drug Administration has approved Enstilar® (calcipotriol/betamethasone dipropionate 50 micrograms/g / 0,5 mg/g) Foam for the treatment of psoriasis vulgaris, in patients 18 years of age or older in the United States. Enstilar® is a once-daily, alcohol-free topical treatment. Read more.



    New Indication Approval

    Yervoy™ (ipilimumab)

    October 28, 2015 — Bristol-Myers Squibb Company announced the U.S. Food and Drug Administration has approved Yervoy™ (ipilimumab) 10 mg/kg for the adjuvant treatment of patients with cutaneous melanoma, with pathologic involvement of regional lymph nodes of more than 1 mm, who have undergone complete resection, including total lymphadenectomy. Read more.



    New Generic Approval

    Memantine Hydrochloride Oral Solution (Namenda® Oral Solution)

    Oct. 14, 2015 /PRNewswire/ — Lannett Company, Inc. announced its wholly owned subsidiary, Silarx Pharmaceuticals, Inc., has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Memantine Hydrochloride Oral Solution 2 mg/mL, the therapeutic equivalent to the reference listed drug Namenda® Oral Solution, 2 mg/mL of Forest Pharmaceuticals. Read more.



    New Drug Shortage

    October 27, 2015


    October 21, 2015


    October 14, 2015



    Drug Safety Alert

    Entacapone: Drug Safety Communication

    October 26, 2015 — An FDA safety review has found no clear evidence of an increased risk of heart attacks, stroke, or other cardiovascular events associated with the use of entacapone for the treatment of Parkinson’s disease. As a result, recommendations for using Comtan™ (entacapone) and Stalevo™ (a combination of entacapone, carbidopa, and levodopa) will remain the same in the drug labels. Read more.


    Hepatitis C Treatments Viekira Pak and Technivie™

    October 22, 2015 — The FDA warns hepatitis C treatments Viekira Pak™ and Technivie™ can cause serious liver injury, mostly in patients with underlying advanced liver disease. As a result, the FDA is requiring the manufacturer to include information about serious liver injury adverse events to the Contraindications, Warnings and Precautions, Postmarketing Experience, and Hepatic Impairment sections of the Viekira Pak™ and Technivie™ drug labels. Read more.


    Kayexalate (sodium polystyrene sulfonate)

    October 22, 2015 — The FDA is requiring the Kayexalate manufacturer to conduct studies to investigate Kayexalate’s potential to bind to other medications administered by mouth—drug interactions that could affect how well the other medications work. Read more.



    Drug Recall Alert

    Acetaminophen Tablets by Medline Industries

    October 14, 2015 — On Oct. 9, 2015, Medline Industries, Inc. announced it will initiate a voluntary nationwide recall of lot # 45810 of Acetaminophen tablets, 500mg, uncoated compressed tablets, to the consumer level. The Acetaminophen 500mg, Tab 100/BT (OTC20101) has been found to be mislabeled, displaying “Acetaminophen 325mg” (OTC10101) instead of “Acetaminophen 500mg.” Read more.



    Clinical and Pharmacy News

    Six Guidelines for Treating Unexplained Chronic Cough

    October 29, 2015 — There is a great need to identify effective treatment approaches for unexplained chronic cough, as the condition can lead to significant decreases in patients’ qualify of life. The American College of Chest Physicians has completed a systematic review of randomized controlled clinical trials to create guideline suggestions, which will be published in an upcoming issue of CHEST. Read more.


    Studies Raise Questions About Impact of Statins on Flu Vaccination in Seniors

    October 29, 2015 — A new pair of studies suggest statins, drugs widely used to reduce cholesterol, may have a detrimental effect on the immune response to influenza vaccine, and the vaccine’s effectiveness at preventing serious illness in older adults. Published in the Journal of Infectious Diseases, the findings, if confirmed by additional research, may have implications for flu vaccine recommendations, guidelines for statin use around the time of vaccination, and future vaccine clinical trials in seniors. Read more.


    Walgreens-Rite Aid Merger Would Pose Challenge to CVS

    October 29, 2015 — When the nation’s second- and third-largest pharmacy chains agree to merge, there can be only one goal: becoming number one. The company that holds that spot, as measured by revenue, is CVS Health Corp. The Woonsocket, R.I., company could soon face new competitive challenges, if regulators and shareholders approve the merger announced this week of its two chief rivals, Walgreens Boots Alliance Inc., of Deerfield, Ill., and Rite Aid Corp., of Camp Hill, Pa., analysts said. Read more.


    Walgreens Store Sales Seen as Hurdle for Rite Aid Deal Approval

    October 29, 2015 — Walgreens Boots Alliance Inc.’s deal to acquire Rite Aid Corp. is expected to draw antitrust scrutiny, not only because the company would grow to 12,700 locations, but because of what goes on behind the scenes with drug payments. Antitrust experts say the Federal Trade Commission, which is likely to review the transaction, will look closely at whether the merging of these pharmacy chains will lead to higher prices for prescription drugs. Read more.


    Lower Diabetes Costs by Improving Medication Adherence

    October 28, 2015 — Although the death rate due to diabetes complications has declined, the rate of patients developing diabetes has risen in recent years, according to the Centers for Disease Control and Prevention (CDC). An estimated 20.9 million Americans were diagnosed with the disease in 2011, and it is the seventh leading cause of death. During the session, “Diabetes—Exploring the New Frontier,” at the Academy of Managed Care Pharmacy Nexus 2015 in Orlando, Heather Sundar, PharmD, vice president, clinical, research and new solutions at Express Scripts, discussed how new diabetes management approaches can help address this growing problem. Read more.


    Pharmacy’s Sales Tactics Disclosed

    October 28, 2015 — A mail-order pharmacy, used by Valeant Pharmaceuticals International Inc., had a simple message for staffers charged with getting health insurers to pay up: Don’t take no for an answer. If a health insurer wouldn’t work with Philidor Rx Services LLC, the pharmacy instructed staff to try again using the identification number of a partner pharmacy to secure payment. Read more.


    Don’t Bank on U.S. Drug Price Rises, Warns GSK Boss

    October 28, 2015 —Pharmaceutical companies cannot depend on ever-increasing prices in the United States, and will need to find a new balance between incentives for innovation and access to medicines, according to the chief executive of GlaxoSmithKline. High drug prices have come under fierce political fire recently in America, the industry’s biggest and most profitable market, with Democratic presidential candidate Hillary Clinton attacking “excessive profiteering.” Read more.


    Walgreen’s Deal Likely to Raise Consumer Costs

    October 28, 2015 — Walgreens Boots Alliance says it isn’t trying to bolster its bargaining clout with its $17.2 billion acquisition of the Rite Aid drug store chain. Instead, it’s trying to improve health care delivery for consumers, CEO Stefano Pessinam says. Others aren’t sure that’s the case. Read more.


    How the Cloud Is Turning Retail Health Providers into Power Players

    October 28, 2015 — Retail health is changing the face of health care delivery by moving care outside the four walls of the hospital, and offering care in drug store chains, grocery stores and superstores. Retail health clinics are staffed by nurse practitioners, who provide treatment for minor illnesses, preventative care and vaccinations. Retail health is on the upswing—more and more people are choosing retail health care before seeking medical treatment in physician offices and hospitals. Read more.


    Rising Fees Pinch Some Pharmacies

    October 28, 2015 — These fees, known as DIR (direct and indirect remuneration), are a small piece of the tangle of contracts, rebates and reimbursements involved in the sale of prescription drugs in the U.S., which totaled $374 billion in 2014, according to the IMS Institute for Healthcare Informatics, a research group. Read more.


    Study Highlights How Little Is Known About How Cancer Spreads

    October 28, 2015 — The rate of breast cancer that doctors diagnose only after it has spread has remained steady through the last three decades. But, rates have dropped for prostate cancer, report researchers in the New England Journal of Medicine, who suggest the reason for the difference underscores the limits of breast cancer science and screening. Three researchers, who include an oncologist and a surgical urologist, propose the steady rate of metastatic breast cancer points to a failure by mammography “to identify at an earlier stage, before symptoms appear, cancers that are destined to become metastatic.” Read more.


    ASHP Updates Best Practices Guidance for Pharmacists

    October 28, 2015 — The American Society of Health-System Pharmacists (ASHP) offers updated guidance for pharmacists, with the release of the ASHP Best Practices 2015-2016 book. This annual publication includes 28 new policy positions, five revised statements and guidelines, and two new guidelines about pharmacist involvement in HIV care, and the design of database-driven clinical decision support (CDS). Read more.


    Electronic Decision Support Improves ADHD Treatment Guideline Adherence

    October 27, 2015 — The use of an electronic template and a uniform workflow improved adherence to AAP evidence-based guidelines for the treatment of attention-deficit hyperactivity disorder with stimulant medication, according to data presented at the 2015 AAP National Conference and Exhibition. Read more.


    Budget Deal Targets High Drug Prices

    October 27, 2015 — A tiny provision in the budget deal takes on soaring generic drug prices, which would hit companies that have been heavily criticized for raising prices. The proposed budget deal, announced by Congress and the White House, would include a provision requiring generic drug makers to rebate Medicaid, if the cost of their drugs outpaces inflation. Read more.


    Patient Engagement and Wellness: A Critical Piece of the Puzzle as Health Care Moves to Value-Based Models

    October 27, 2015 — When the Institute of Medicine (IOM) released its landmark 2001 “Crossing the Quality Chasm” report, it called for providers to support continuous healing “relationships” with their patients. Although we have seen some progress through the proliferation of patient-centered medical homes (PCMHs), most clinicians have not fundamentally altered their basic approach to engaging with their patients. Read more.


    Novartis shells Out $390M to Settle Specialty Pharmacy Kickback Claims

    October 27, 2015 — Novartis ($NVS) agreed to pay about $390 million to wrap up federal kickback claims, before the $3.3 billion case went to trial. The Justice Department and a number of U.S. states had sought up to $3.4 billion in damages in the case, which zeroed in on the Swiss drug maker’s relationships with specialty pharmacies. Read more.


    Big Pharma Won’t Stay Silent in Drug Pricing Debate for Long

    October 22, 2015 — Lately, pharma execs have been taking yet another volley of criticism over drug pricing practices from Hillary Clinton and Marco Rubio—and plenty of others—without offering much in the way of a defense. Now two CEOs say the industry—whose stocks tumbled after a Clinton tweet about ‘price gouging’ and whose share prices have been ailing since July—is quietly formulating its response plan. Read more.


    U.S. Drug Prices Should Reflect Value to Patients: Expert Panel

    October 23, 2015 — A panel of medical experts said the prices of prescription medicines in the United States need to be brought in line with the value they bring to patients, instead of continuing to let drugmakers set any price they choose. “Americans at the same time are getting tremendously ripped off with drugs, and also getting tremendous value, and we almost never know when we’re getting ripped off, and when we’re getting real value, and that has to change,” said Steven Pearson, president of the Institute for Clinical and Economic Review (ICER), an independent nonprofit group that evaluates clinical and cost-effectiveness of new medicines. Read more.


    NCPA Urges Congress, Medicare to Expand MTM Utilization

    October 21, 2015 — Medicare can achieve the dual goals of better health outcomes for the program’s beneficiaries and lower overall costs, if the medication therapy management (MTM) services of community pharmacists are better utilized, the National Community Pharmacists Association (NCPA) said in comments submitted to a congressional committee. As the House Energy and Commerce Subcommittee on Health conducted a hearing on MTM in the Medicare Part D program, NCPA proposed several enhancements to benefit patients and taxpayers alike. Read more.


    Drug Makers Sidestep Barriers on Pricing

    October 19, 2015 — The pain reliever Duexis is a combination of two old drugs, the generic equivalents of Motrin and Pepcid. If prescribed separately, the two drugs together would cost no more than $20 or $40 a month. By contrast, Duexis, which contains both in a single pill, costs about $1,500 a month. Read more.


    To Reduce the Cost of Drugs, Look to Europe

    October 19, 2015 — When anyone proposes reducing prescription drug prices—as Hillary Rodham Clinton and Bernie Sanders recently have—the most commonly heard criticism is that it would squelch innovation. But not all pharmaceutical innovation is valuable. Though some drugs are breakthroughs, some offer only marginal benefits at exorbitant cost. Read more.


    Four Reasons Drugs Are Expensive, of Which Two Are False

    October 13, 2015 — If I offered to buy your shoes you would think I was strange, but we could probably haggle a price. If I offered to buy your children, we would not get to the haggling stage. The difference between trading shoes and children is not merely legal. It is also moral. People find it unpalatable, even taboo, to put prices on things that we treat as absolutes; life, liberty, or health. People have moral qualms about the cost of medicines for the sick or dying, but not about the cost of Botox or liposuction. Read more.


    An Antidote for Escalating Drug Prices: ‘Reciprocity’ of Regulatory Approvals

    October 14, 2015 — The highly publicized, sudden, 55-fold spike in the cost of the anti-parasite drug, Daraprim, has elevated drug pricing to the political realm—with unfortunate consequences. On Sept 18, the Center for American Progress, aka Hillary Clinton’s think tank, released a plan for “Public- and Private-Sector Reforms to Curb Rising Drug Costs,” which largely substitutes the wisdom of bureaucrats and jerry-built price controls for entrepreneurship and markets. Read more.


    Valeant Under Investigation for Its Drug Pricing Practices

    October 14, 2015 — Valeant Pharmaceuticals International, which has come under fire for aggressively increasing the prices of its drugs, said it had received two federal subpoenas related to its pricing, distribution and patient support practices. The subpoenas were issued by the United States attorney’s offices in Manhattan and Massachusetts. Read more.



    Key 340B News

    340B Orphan Drug Interpretive Rule Struck Down by D.C. District Court: HHS and HRSA Lose in Second Round of Litigation over 340B Orphan Drug Rules

    October 26, 2015 — In an Opinion issued October 14, 2015, D.C. District Court Judge Rudolph Contreras granted Pharmaceutical Research and Manufacturers of America’s (PhRMA) motion for summary judgment against the U.S. Department of Health and Human Services (HHS) (and, by extension, the Health Resources and Services Administration (HRSA)). Read more.