RxStrategies Clinical Insights – May 2015 Issue 1

    Welcome to the May 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 Approvals

    Kybella™ (deoxycholic acid)

    April 29, 2015 – The U.S. Food and Drug Administration approved Kybella™ (deoxycholic acid), a treatment for adults with moderate-to-severe fat below the chin, known as submental fat. Using Kybella™ for the treatment of fat outside of the submental area is not approved and is not recommended. Kybella™ is identical to the deoxycholic acid that is produced in the body. Deoxycholic acid produced in the body helps the body absorb fats. Kybella™ is a cytolytic drug, which when injected into tissue physically destroys the cell membrane. When properly injected into submental fat, the drug destroys fat cells; however, it can also destroy other types of cells, such as skin cells, if it is inadvertently injected into the skin. Read more.


    New Drug Formulation

    Tuzistra™ XR (codeine polistirex and chlorpheniramine polistirex)

    May 1, 2015 – Vernalis plc and Tris Pharma Inc. announced the U.S. Food and Drug Administration has approved the New Drug Application (NDA) for Tuzistra XR (codeine polistirex and chlorpheniramine polistirex) extended-release oral suspension, CIII (DEA Schedule III). Tuzistra XR is an extended-release oral suspension combination of codeine, an opiate agonist antitussive, and chlorpheniramine, a histamine-1(H1) receptor antagonist, indicated for relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults aged 18 years and older. It is indicated for oral use, with or without food, and is to be dosed every 12 hours. Read more.

    Raplixa™ (fibrin sealant [human])

    April 30, 2015 – The U.S. Food and Drug Administration approved Raplixa™ (fibrin sealant [human]), the first spray-dried fibrin sealant approved by the agency. It is used to help control bleeding during surgery. Raplixa™ is a biological product approved for use in adults to help control bleeding from small blood vessels, when standard surgical techniques, such as suture, ligature or cautery, are ineffective or impractical. When applied to a bleeding site, Raplixa™ is dissolved in the blood and a reaction starts between the fibrinogen and thrombin proteins. This results in the formation of blood clots to help stop the bleeding. Raplixa™ contains fibrinogen and thrombin, two proteins found in human plasma, the liquid portion of blood. Read more.

    Ixinity® [coagulation factor IX (recombinant)]

    April 30, 2015 – Emergent BioSolutions Inc. announced the U.S. Food and Drug Administration has approved Ixinity® [coagulation factor IX (recombinant)], an intravenous recombinant human coagulation factor IX therapeutic for the control and prevention of bleeding episodes and for perioperative management in adults and children, ≥12 years of age, with Hemophilia B. Hemophilia B is a bleeding disorder caused by a mutation on the factor IX gene, resulting in a deficiency of clotting factor IX in the blood, which controls bleeding. Read more.


    New Drug Indication 

    Avelox® (moxifloxacin)

    May 11, 2015 – The U.S. Food and Drug Administration (FDA) approved Avelox® (moxifloxacin) to treat patients with plague, a rare and potentially fatal bacterial infection. The agency approval for plague includes use of the drug for the treatment of pneumonic plague (infection of the lungs), and septicemic plague (infection of the blood). Avelox® is also approved for prevention of plague in adult patients. Read more.

    Breo® Ellipta®

    April 30, 2015 – GlaxoSmithKline plc and Theravance, Inc. announced the U.S. Food and Drug Administration (FDA) has approved Breo® Ellipta® (fluticasone furoate/vilanterol [FF/VI]) for the once-daily treatment of asthma in patients aged 18 years and older. Breo® Ellipta® is not indicated for the relief of acute bronchospasm. Breo® is a fixed-dose combination of the inhaled corticosteroid (ICS) fluticasone furoate (FF) and the long-acting beta2-agonist (LABA) vilanterol (VI). Two strengths, 100/25mcg and 200/25mcg, have been approved in the U.S. for use in asthma, administered once a day using the Ellipta dry powder inhaler. Read more.

    Cyramza® (ramucirumab)

    April 24, 2015 – The U. S. Food and Drug Administration approved ramucirumab (Cyramza®) for use in combination with FOLFIRI for the treatment of patients with metastatic colorectal cancer (mCRC), whose disease has progressed on a first line bevacizumab-, oxaliplatin- and fluoropyrimidine-containing regimen. Ramucirumab is a recombinant human monoclonal IgG1 antibody that binds to the human vascular endothelial growth factor-receptor 2 (VEGF-R2), preventing the interaction of VEGF-R2 to its ligands. This approval is based on the results of a randomized, double-blind, multinational trial, enrolling patients with mCRC that progressed during or within six months of discontinuation of bevacizumab-, oxaliplatin- and fluoropyrimidine-based combination chemotherapy. Read more.


    New Generic Approval

    Aripiprazole (Abilify®)

    April 28, 2015 – The U.S. Food and Drug Administration today approved the first generic versions of Abilify® (aripiprazole). Generic aripiprazole is an atypical, antipsychotic drug, approved to treat schizophrenia and bipolar disorder. Alembic Pharmaceuticals Ltd., Hetero Labs Ltd., Teva Pharmaceuticals and Torrent Pharmaceuticals Ltd. have received FDA approval to market generic aripiprazole in multiple strengths and dosage forms. Read more.


    New Drug Shortage

    May 11, 2015

    Calcium Chloride Injection, USP (Currently in Shortage)

    April 21, 2015

    Methylene Blue Injection (Currently in Shortage)


    Drug Recall Alert 

    Adrucil (fluorouracil Injection, USP) 5 g/100 mL (50 mg/mL)

    May 5, 2015 – Teva Parenteral Medicines issued a voluntary recall of eight lots of Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL), due to the potential presence of particulate matter identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals. Administration of an intravenous product with particulate matter has the potential to result in inflammation, allergic reactions, or blockage of blood vessels, leading to tissue death, which may be life-threatening if vital organs are affected. Read more.

    Injectable Products by Mylan: Recall

    April 24, 2015 – Mylan N.V. is conducting a voluntary nationwide recall to the hospital/user level of select lots of injectable products (Gemcitabine for Injection, Carboplatin Injection, Methotrexate Injection, Cytarabine Injection) due to the presence of visible foreign particulate matter observed during testing of retention samples. Administration of a sterile injectable that has foreign particulates has the potential of severe health consequences. Intrathecal administration could result in a life-threatening adverse event or in permanent impairment of a body function. Intravenous administration has the potential to damage and/or obstruct blood vessels, which could induce emboli, particularly in the lungs. If a right-to-left cardiac shunt is present, the particulate may lead to arterial emboli and result in stroke, myocardial infarction, respiratory failure, loss of renal and hepatic function or tissue necrosis. Read more.

    Bupivacaine HCl Injection by Hospira

    April 24, 2015 – Hospira issued a voluntary recall of one lot of Preservative-Free Bupivacaine HCl Injection, USP, 0.5% (5 mg/mL), 30 mL Single-dose (NDC: 0409-1162-02, Lot 38-515-DK, Expiry 1FEB2016), due to one confirmed customer complaint of orange and black, visible particles embedded and free floating within a single-dose glass teartop vial. The particles were identified as iron oxide. This recall is being carried out to the user level (both human and veterinary). Read more.


    Clinical and Pharmacy News 

    High Prices for Drugs to Treat Rare Diseases Take a Toll

    May 12, 2015 – Let me start with a confession: I had never heard of the little Synageva BioPharma Corp. before another company agreed to buy it for $8.4 billion last week. The sale of the Lexington biotech company was remarkable on many counts—none more striking than the fact that it has no products for sale. Synageva hopes to win U.S. approval later this year for a drug to treat a disease estimated to afflict just 3,000 people in the entire developed world. It also has some other potential drugs in its development pipeline. Read more. 

    Big Win for Pharmacist Provider Status in Washington State

    May 11, 2015 – Washington State Governor Jay Inslee signed into law on May 11, 2015 a bill that makes Washington the first state in the country to require that pharmacists are included in health insurance provider networks. Washington State Pharmacy Association (WSPA) CEO Jeff Rochon, PharmD, said it was a team effort to push this bill through. The association worked hand-in-hand with sponsoring legislator Senator Linda Evans Parlette, a pharmacist herself, on SB 5557. Read more.

    New Accreditation Process Available for Compounding Pharmacies

    May 7, 2015 – United Compounding Management (UCM) announced a strategic partnership with the National Association of Boards of Pharmacy (NABP) to enhance the process and standards of accreditation for compounding pharmacies. NABP, a national, impartial professional organization, whose key mission is focused on supporting state boards of pharmacy in protecting public health, will be administering the United Compounding Credentialing and Accreditation Program (UCAP) exclusively for UCM. UCM is an independent compounding management company that applies techniques and tools to make quality compounding affordable and accessible. Read more.

    FDA to Hold Public Meeting on Off-Label Use of Prescription Drugs

    May 7, 2015 – The U.S. Food and Drug Administration will hold a public meeting this summer to address drug company concerns that restrictions on what they can say about off-label use of drugs violate their First Amendment right to free speech. The meeting, announced last month by FDA chief counsel Elizabeth Dickinson, comes as a bill known as 21st Century Cures, designed to speed new drugs to market, is moving through Congress. Language in the bill is adding pressure on the agency to relax its guidelines. Read more. 

    Hot Drugs Show Sharp Price Hikes in Shadow Market

    May 6, 2015 – On May 30 last year, the price for a vial of the blockbuster diabetes medication Lantus went up by 16.1 percent. The next day, Lantus’s direct competitor, Levemir, also registered a price increase of 16.1 percent. The pattern repeated itself six months later when Lantus, from French drugmaker Sanofi, was marked up 11.9 percent, and Levemir, made by Novo Nordisk A/S, matched again exactly. In 13 instances since 2009, prices of Lantus and Levemir—which dominate the global market for long-acting injectable insulin with $11 billion in combined sales—have gone up in tandem in the U.S., according to SSR Health, a market researcher in Montclair, New Jersey. Read more. 

    New Cancer Drugs Are Expensive, but Price Controls Are Misguided

    May 6, 2015 – CBS’s Sixty-Minutes recently featured cancer specialists decrying the high prices charged for anti-cancer drugs in America. They claimed patients are suffering and even prematurely dying, because they cannot access or take prescribed doses of these drugs. They have launched a grassroots campaign of physicians and patients demanding the government control drug prices. Their remedy, however, based on “conflict-of-interest” myths, is misguided. “Conflict-of-interest” myths debase the medical products industry and health care professionals who interact with it. The cancer specialist’s particular myth is that medical product companies do not really innovate, but simply expropriate university research to make drugs for which they overcharge. Here’s why they are wrong. Read more.

    AJHP Explores Trends in Increased US Drug Spending

    May 5, 2015 – A wave of innovation in specialty medications, which caused U.S. prescription drug spending to spike significantly in 2014, is examined in three separate articles in the May 1 issue of the American Journal of Health-System Pharmacy (AJHP). The articles provide a deeper look into the factors driving drug expenditures and the increasing role of specialty pharmacies. A special feature analyzes trends in pharmaceutical spending and presents projections for 2015, including nonfederal hospital and clinic settings. Using data from IMS Health, the authors analyze 2014 drug expenditures by sector, drug and drug class, and explore factors that may impact future drug spending, such as new drug approvals and patent expirations. They conclude spending will increase in 2015 by 7 to 9 percent across all settings, by 12 to 14 percent in clinics, and by 5 to 7 percent in hospitals. Read more.

    The Cancer Drug Market Just Hit $100 Billion and Could Jump 50% in Four Years

    May 5, 2015 – The global market for cancer drugs has hit $100 billion in annual sales, and could reach $147 billion by 2018, according to a new report by the IMS Institute for Healthcare Informatics, a unit of drug data provider IMS Health. This figure does not include discounts or rebates paid to insurers and government programs; IMS says in the case of cancer drugs, this should not make a big difference in the overall figure. Read more.

    New Study Suggests Prominent Role for Pharmacies In Reducing Asthma-Related Illness

    May 4, 2015 – A new study shows how pharmacies might collaborate with physicians and families to reduce asthma-related illness. The Cincinnati Children’s Hospital Medical Center study found that pharmacies in neighborhoods with high rates of asthma-related emergency-room use and hospitalization filled fewer asthma controller medications compared to asthma rescue medications. Read more. 

    Medicare Releases Detailed Data on Prescription Drug Spending

    April 30, 2015 – The heartburn drug Nexium—whose advertisements have long been ubiquitous on television—was prescribed to 1.5 million Medicare patients in 2013, for a total cost of more than $2.5 billion, the largest amount spent on any drug prescribed through the government program, according to data released by Medicare officials on Thursday. The data was the most detailed breakdown ever provided by government officials about the prescription claims of Medicare beneficiaries. It included information about 36 million patients, one million prescribers and $103 billion in spending on drugs under the program’s Part D in the year 2013, the most recent year available. The data did not take into account rebates the drug manufacturers pay to the insurers who operate the Medicare beneficiaries’ drug plans. Read more.  

    Small Number of Drugs Drives Big Medicare Bill, Spending Data Show

    April 30, 2015 – Costly drugs for diseases, such as cancer and multiple sclerosis, account for more than a quarter of spending on prescriptions for America’s elderly and disabled, despite being used by relatively few patients, according to newly released data from Medicare’s prescription-drug program. The data, which cover prescription-drug claims paid in 2013, show that out of nearly 3,500 drugs prescribed that year, roughly 400 with a cost of $3,000 or more per beneficiary added up to $26.5 billion. Read more.

    Preferred Retail Pharmacies Included in Defense Budget

    April 30, 2015 – Next year’s federal defense authorization bill approved today by the House Armed Services Committee includes a proposal to pilot a “preferred” retail pharmacy network for Tricare beneficiaries. The program, which would run from May 1, 2016 to September 30, 2018, could potentially lead to financial savings for the Department of Defense, the legislation suggests. “The pilot program would include, but not be limited to, best practices from non-Tricare health plans that use preferred retail pharmacy networks,” the bill states.

    Read more.

    American Diabetes Association Releases Diabetes Guidelines For Primary-Care Providers

    April 27, 2015 – An abridged version of the “2015 Standards of Medical Care in Diabetes” has been produced for primary-care practitioners. The guidelines were published in Clinical Diabetes.

    The condensed guidelines, produced by researchers from the American Diabetes Association (ADA) and the ADA Primary Care Advisory Group (PCAG), specifically focus on evidence-based recommendations for primary-care providers (PCPs). Read more.

    Doctors Prescribe Medicine for Their Patients, but the Pharmacy Won’t Fill Them. Why?

    April 27, 2015 – Some pharmacists blame the DEA for overreaching in the wake of the pill mill crack down. Now the head of the Drug Enforcement Administration in Tampa is answering those allegations. Legitimate patients living with crushing pain day in and day out say their pharmacists turned off their medicine supply like a switch. Never ending—that’s how Robert Harris describes his back pain. A car crash compounded his chronic back issues. For the last nine months, Robert has gone to the same doctor who’s prescribed the same pain medicine in the same dosage. But the pharmacy notified Harris it would no longer fill his prescriptions. Desiree Harris said they were not given reason. And, other chain and grocery store pharmacies turned Robert away as well, saying they were out of supply. Read more.

    When the Hospital’s Drug Cabinet Is Bare

    April 24, 2015 – I worry about a lot of things that could go wrong if I’m taken to a hospital, but until today this hasn’t been one of them: Hospitals are routinely running short of critical antibiotics, often for months at a time. When Larissa May, an associate professor of emergency medicine at George Washington University, and a team of researchers checked, they found hospitals across the country ran short of 148 anti-bacterial drugs over a 13-year period, from 2001 to 2013. The average time without a drug was nearly nine months (injectable drugs generally ran short for even longer periods than medications taken by mouth). Thirty-two of the medications ran short more than once, including one, Meropenem, which was short seven different times for a total of 1,114 days. Read more. 

    How Much Would You Pay for an Old Drug? If You Have MS, a Fortune

    April 24, 2015 – Imagine Apple’s first iPhone is still on sale today. Now imagine it costs many times its original price of $599, and that the price goes up every time a new, competing phone is released. That bizarro world is what the market for multiple sclerosis drugs looks like, as described in a new paper in the journal Neurology. And, doctors are calling for it to change. MS is a chronic disorder of the nervous system that afflicts about 400,000 Americans with a variety of symptoms, including fatigue, difficulty moving and vision problems. When the first therapies to treat MS were approved in the 1990s, they cost $8,000 to $12,000 a year. Subsequent drugs entered the market with higher prices. The competition didn’t drive down cost, as Economics 101 would predict. Instead, the prices of the older drugs increased and rose several times faster than the overall rate at which drug costs increased. Read more. 

    Federal Investigators Will Look Into Generic Drug Price Hikes

    April 21, 2015 – Mimicking a trend that’s been going on in recent years with brand-name drugs, reports have now surfaced that costs for most generic medications are also going up, prompting federal investigators to look into the issue. At the urging of Sen. Bernie Sanders (I-VT) and Rep. Elijiah Cummings (D-MD), the Office of the Inspector General (OIG) of the U.S. Department of Health & Human Services (HHS) said it will conduct an investigation of generic drug price increases on the Medicaid drug rebate program. Read more.

    New Guidelines for Treatment of First Seizure

    April 20, 2015 – Taking epilepsy drugs immediately after a first seizure may reduce the risk of having another seizure, according to new seizure guidelines published by the American Academy of Neurology and the American Epilepsy Society. Deciding how to address a first seizure is a complex decision, and with one in 10 people likely to experience a seizure, the organizations came together to create more clear guidelines. Read more.

    Meds Trump Therapy Recommendation for Treating ADHD

    April 20, 2015 – When it comes to treating attention-deficit hyperactivity disorder (ADHD) a lot of kids are getting the meds they need—but they may be missing out on other treatments. Despite clinical guidelines that urge behavioral therapy always be used alongside medication, less than half of the children with ADHD received therapy as part of treatment in 2009 and 2010, according to the first nationally representative study of ADHD treatment in U.S. children. Read more.


    340B in the News

    340B ‘Mega-Guidance’ Arrives at Office of Management and Budget

    May 7, 2015 – The Health Resources and Services Administration (HRSA) submitted guidance on the 340B Federal Drug Pricing Program (340B Program) to the federal Office of Management and Budget (OMB) for review. The guidance, entitled “340B Program Omnibus Guidelines,” is expected to address a broad range of topics within the 340B Program, including the definition of patient, contract pharmacy compliance requirements, hospital eligibility criteria and eligibility of off-site outpatient locations. HRSA has indicated publicly the guidance will be in proposed form, and there will be opportunity for public comment before the guidance is finalized. Read more.

    Congress Should Keep Drug Discount Program

    May 7, 2015 – It’s our mission to take care of whoever walks through our doors. Whether critically ill, poor or in decent health, it doesn’t matter; at Mercy Medical Center-Des Moines, we help all of our patients get the medicine and care they need to get better and remain healthy. As a “safety net” hospital, we treat everyone, including our nation’s most vulnerable patients. These are the men, women and children who would otherwise not be able to afford health care when they need it most. Read more.

    Can Drug Companies Be Shamed into Limiting Price Hikes?

    May 6, 2015 – The skyrocketing cost of drugs and political threats to the federal 340B Drug Pricing Program have emerged as a common concern at this week’s annual meeting of the American Hospital Association. As I reported in this space Monday, safety net hospitals consider the federal 340B Drug Pricing Program “mission critical” and fervently hope the program does not fall victim to the intense lobbying now taking place by the pharmaceutical industry among federal and state lawmakers. Representatives of Ascension Health yesterday echoed those sentiments in an interview between sessions at the AHA meeting. Read more.

    For Safety Net Providers, 340B Drug Pricing Program Is ‘Mission Critical’

    May 4, 2015 – With the Health Resources and Services Administration coming under criticism for what some call lax oversight of the 340B drug pricing program, safety net hospitals should get ready for more audits and the release of “mega-guidance” by the agency sometime this summer. At a briefing yesterday at the American Hospital Association’s annual membership meeting in Washington, D.C., Christopher Hatwig, president of Apexus, a designated 340B prime vendor, said it is essential for hospital executives to become engaged in their organization’s 340B oversight. He advised them to identify internal and external expert resources for self-auditing, communicate with their state Medicaid agencie and form a 340B compliance team to network with recently audited peers to better understand the process and where they may need to strengthen their own practices. Read more.

    Inequities of 340B Drug Pricing Program May Last, Despite Rising Concern

    May 3, 2015 – Frustration is mounting with a federal program, originally designed to allow hospitals that care for underserved people to purchase outpatient drugs at discounted prices. Just ask Dr Gina Villani, an oncologist in Harlem, New York City. Eighty-five percent of her patients are insured through Medicaid, but her clinic does not qualify for 30B Drug Pricing Program discounts. It is owned by Memorial Sloan Kettering (MSK), which, as an institution, doesn’t meet the 11.75 percent Medicaid patient requirement. As a result, Villani’s Ralph Lauren Center for Cancer Care and Prevention relies heavily on charity to subsidize the cost of treatment.Read more. 

    House Subcommittee Members Express Support for 340B Program; Need Clarity, Oversight and Transparency

    May 1, 2015 – The House of Representatives Energy and Commerce Health Subcommittee held a 340B Program hearing, with testimony from the Deputy Administrator of Health Resources and Services Administration (HRSA), the Director of the Office of Pharmacy Affairs (OPA) of HRSA, the Director of Health Care of the Government Accountability Office (GAO) and Assistant Inspector General of the Office of Evaluation and Inspection of the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG). Read more.

    Drug Discount Program Helps Hospital Care for Patients

    May 1, 2015 – Heart of America Medical Center of Rugby’s mission is to take care of whoever walks through our doors. Whether critically ill, poor or in decent health, it doesn’t matter: we help all of our patients get the care and medicine they need to get better and remain healthy. We treat everyone, including our nation’s most vulnerable patients. These are the men, women and children who would otherwise not be able to afford health care when they need it most. Providing excellent care to the poor is a tall order, but a little-known federal program lends a helping hand. Established in 1992, the 340B Program requires pharmaceutical companies to give discounts on drugs to hospitals like ours that treat high numbers of under-privileged patients. Read more. 

    Grassley and Pitts Fighting Cronyism in 340B Program

    April 30, 2015 – DUH is the acronym for Duke University Hospital, and that seems somewhat appropriate considering its participation in what is known as the 340B Program. The program, whose name comes from its place in the Public Health Service Act, began in 1992 as part of veterans’ legislation. It was designed to provide drugs at reduced prices to hospitals and other health care facilities that treat the poor. Read more.

    340B Audits 101: To Survive, Foresight Is Key

    April, 27, 2015 – The best thing a hospital can do to survive a Health Resources and Services Administration (HRSA) audit of its 340B drug discount program is to be prepared, presenters said during two talks on surviving audits at the American Society of Health-System Pharmacists 2014 Midyear Clinical Meeting. The strategies include involving hospital leadership, conducting regular self-audits to look for potential problems, and maintaining accurate, up-to-date records. Read more.

    California Patient Advocates Call on Congress to Reform 340B Drug Discount Program
    April 27, 2015 – In an effort to strengthen the 340B federal drug discount program, to ensure it supports access to outpatient prescription medications for uninsured or indigent patients, leading California patient advocacy organizations representing chronic illnesses, including autoimmune arthritis hepatitis C and lung cancer, have called on Congress to intervene. In a joint letter to House Majority Leader Rep. Kevin McCarthy (R-23) and Rep. Tony Cardenas (D-29), patient advocates concerned about the abuses occurring in the 340B program stated: “By most accounts, the 340B Program’s scale has far exceeded its original intent. Continued oversight of the 340B Program is needed to ensure it is consistent with its statutory promise; there has only been one Congressional hearing in more than twenty years despite the program’s rapid growth. Improved transparency of the 340B Program will help advance the program’s goals and ensure resources are being directly used to reduce medicine costs for the patients who truly need it.” Read more.