RxStrategies Clinical Insights — October Issue 1

    Welcome to the first October 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

    Tresiba® (insulin degludec injection)

    September 25, 2015 — The U.S. Food and Drug Administration approved Tresiba® (insulin degludec injection) and Ryzodeg® 70/30 (insulin degludec/insulin aspart injection) to improve blood sugar (glucose) control in adults with diabetes mellitus. Tresiba® is a long-acting insulin analog indicated to improve glycemic control in adults with type 1 and 2 diabetes mellitus. Dosing of Tresiba® should be individualized, based on the patient’s needs. Tresiba® is administered subcutaneously once daily, at any time of day. Read more.


    Ryzodeg® 70/30 (insulin degludec injection and insulin aspart injection)

    September 25, 2015 — The U.S. Food and Drug Administration approved Tresiba® (insulin degludec injection) and Ryzodeg® 70/30 (insulin degludec/insulin aspart injection) to improve blood sugar (glucose) control in adults with diabetes mellitus. Ryzodeg 70/30 is a mixture of insulin degludec, a long-acting insulin analog, and insulin aspart, a rapid-acting human insulin analog. It is indicated to improve glycemic control in adults with diabetes mellitus. Read more.


    Lonsurf® (trifluridine and tipiracil)

    September 22, 2015 — The U.S. Food and Drug Administration approved Lonsurf® (trifluridine and tipiracil) for patients with an advanced form of colorectal cancer who are no longer responding to other therapies. Lonsurf® is an oral medication intended to treat patients with advanced (metastatic) colorectal cancer who have been previously treated with chemotherapy and biological therapy. Read more.


    Vraylar™ (cariprazine)

    September 17, 2015 — The U.S. Food and Drug Administration approved Vraylar™ (cariprazine) capsules to treat schizophrenia and bipolar disorder in adults. The efficacy of Vraylar™ in treating schizophrenia was demonstrated in 1,754 participants in three six-week clinical trials. In each of the trials, Vraylar™ was shown to reduce the symptoms of schizophrenia compared to placebo. The efficacy of Vraylar™ in treating bipolar disorder was shown in three three-week clinical trials of 1,037 participants. Vraylar™ was shown to reduce symptoms of bipolar disorder in each of the trials. Read more.



    New Formulation Approval

    GenVisc 850® (sodium hyaluronate)

    October 7, 2015 — OrthogenRx Inc. announced the U.S. Food and Drug Administration approval of GenVisc 850® (sodium hyaluronate) for the treatment of patients with osteoarthritis (OA) knee pain. GenVisc 850® is a solution of purified hyaluronic acid (sodium hyaluronate; HA), similar to the normal knee fluid. HAs replace the fluid in the knee that has degraded with the development of OA. In clinical studies Has—commonly injected three to five times weekly into the knee—have been shown to provide patients up to six months pain relief. Read more.


    Aristada™ (aripiprazole lauroxil)

    October 5, 2015 — Alkermes plc announced the U.S. Food and Drug Administration has approved Aristada™ (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia. Aristada™ is the first atypical antipsychotic with once-monthly and six-week dosing options for delivering and maintaining therapeutic levels of medication in the body through an injection. Alkermes is preparing to launch Aristada™ immediately. Read more.



    New Indication Approval

    Opdivo® (nivolumab)

    October 1, 2015 — Bristol-Myers Squibb Company announced the U.S. Food and Drug Administration approved Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab), for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. The announcement marks the first and only FDA approval of a regimen of two immuno-oncology agents in cancer. This indication is approved under accelerated approval, based on tumor response rate and durability of response. Read more.


    Reyataz® (atazanavir)

    September 24, 2015 — The Prior Approval Supplemental new drug application, NDA 206352/S-003, proposes to expand the use of Reyataz® (atazanavir) oral powder, in combination with other antiviral agents, for treatment of HIV-1 infection in pediatric patients, who are at least three (3) months of age and who weigh between five to less than ten kilograms (5 to < 10 kg). Read more.


    Spiriva® Respimat® (tiotropium)

    September 16, 2015 – Boehringer Ingelheim Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration approved Spiriva® Respimat® for the long-term, once-daily, prescription maintenance treatment of asthma, in people ages 12 and older. Spiriva Respimat is not a treatment for sudden asthma symptoms. Read more.


    Humira® (adalimumab)

    September 10, 2015 — AbbVie announced the U.S. Food and Drug Administration approved Humira® (adalimumab) for the treatment of moderate to severe hidradenitis suppurativa (HS). Humira® is now the first and only FDA-approved therapy for adults with HS. RxS Clinical Insight: This is an orphan indication approval for Humira®. Read more.



    New Generic Approval

    Leflunomide (Arava®)

    October 7, 2015 — Sanofi U.S. announced the availability of an authorized generic version of Arava®, Leflunomide tablets through Winthrop, the company’s U.S. generics division. For people living with rheumatoid arthritis (RA), Leflunomide blocks autoimmune antibodies to reduce inflammation, with the aim of improving mobility. Sanofi’s authorized generic version is the same formulation as the original drug, Arava®, for which the company holds the original patent. Read more.


    Paliperidone extended-release (Invega®)

    September 25, 2015- Allergan plc announced it has launched a generic version of Janssen’s Invega® (paliperidone extended-release tablets) in the U.S. Allergan is the first company to receive FDA approval for and launch a generic version of Invega®, demonstrating the deep expertise of the company’s global generics R&D, regulatory and supply chain teams. Read more.


    Fluvastatin sodium extended-release (Lescol XL®)

    September 18, 2015 — Mylan N.V. announced the U.S. launch of Fluvastatin Sodium Extended-release Tablets, 80 mg, which is the generic version of Novartis’ Lescol XL® Tablets. Mylan received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for this product, which is indicated to reduce elevated total cholesterol, LDL-C, Apo B, and triglyceride, and increase HDL-C in adults with primary hypercholesterolaemia and mixed dyslipidaemia. Read more.



    New Drug Shortage

    October 8, 2015

    Metoprolol Tartrate Injection, USP (Lopressor) (Discontinuation)


    October 6, 2015

    Ioxilan Injection (Oxilan) (Discontinuation)


    September 28, 2015

    Scopolamine Hydrobromide Injection, USP (Discontinuation)


    September 24, 2015

    PEGINTRON (peginterferon alfa-2b) Vials (Discontinuation)


    September 23, 2015

    Ribavirin (REBETOL) USP Capsules (Discontinuation)



    Drug Safety Alert

    Avycaz™ (ceftazidime and avibactam)

    September 22, 2015 — The FDA is warning health care professionals about the risk for dosing errors with the intravenous antibacterial drug Avycaz™ (ceftazidime and avibactam), due to confusion about the drug strength displayed on the vial and carton labels. Avycaz™ was initially approved with the vial and carton labels displaying the individual strengths of the two active ingredients (i.e., 2 gram/0.5 gram); however, the product is dosed based on the sum of the active ingredients (i.e., 2.5 gram). To prevent medication errors, the FDA revised the labels to indicate that each vial contains Avycaz™ 2.5 gram, equivalent to ceftazidime 2 gram and avibactam 0.5 gram. Read more.



    Clinical and Pharmacy News

    Cancer Doctors Decline Pricey Drugs; Should Celgene Corporation and Eli Lilly Be Worried?

    October 12, 2015 — Celgene Corporation and Eli Lilly & Co. can expect dents in their revenue as oncologists in the U.S. consider blocking cancer drugs, which have little to no effect on patients. The decision builds upon efforts being made by the health system to control rapidly increasing prices of cancer drugs. Read more.


    Should Boards of Pharmacy Set Hourly Dispensing Quotas?

    October 10, 2015 — A friend e-mailed me about the failure of employers today to provide enough pharmacists and pharmacy staff to properly and safely handle high prescription volumes in pharmacies. He believes this is a major cause of prescription medication errors, and proposed that boards of pharmacy essentially set quotas for the number of prescriptions that should be filled in a given time, by a calculated number of pharmacists and staff. Read more.


    The State of E-Prescribing of Controlled Substances

    October 10, 2015 — Now that electronic prescribing of controlled substances (EPCS) is permitted in all U.S. states, pharmacists can expect e-prescriptions to gain momentum. Ken Whittemore Jr., RPh, MBA, senior vice president of professional and regulatory affairs at Surescripts, provided an update on EPCS at the National Community Pharmacists Association (NCPA) Annual Convention, which is taking place in Washington, DC, from October 10-14, 2015. Read more.


    Pharmacy Pays $9 Million to Settle Kickback Allegations

    October 9, 2015 — A Kentucky pharmacy will pay $9.25 million to resolve allegations it received kickbacks from a manufacturer for recommending physicians prescribe a certain drug. Federal prosecutors alleged that PharMerica Corp. of Louisville solicited and received kickbacks from Abbott Laboratories for promoting Depakote for nursing home patients. Read more.


    House Majority Supports Pharmacy Access in Medically Underserved Communities

    October 9, 2015 — The American Pharmacists Association announced The Pharmacy and Medically Underserved Areas Enhancement Act (H.R. 592/S. 314) reached an important milestone in the U.S. House of Representatives, having a majority of members support the legislation. “This is a crucial moment in the public debate on how to improve health care access and how to reduce America’s health care costs,” stated Thomas Menighan, APhA EVP and CEO. “National surveys show Americans believe pharmacists are integral members of their health care team. Now, the majority of the U.S. House has stated that they agree.” Read more.


    In the Field: Providing Convenient Patient Care Through Mass Merchandiser Pharmacies

    October 9, 2015 — For a number of pharmacists, mass merchandiser pharmacies offer opportunities to provide patient care that may not be available to those in hospitals or smaller retail pharmacies. Larry Rutebuka, PharmD, a pharmacist with Walmart, was initially drawn to this setting by the greater number of patients he would be able to serve. Read more.


    What’s Driving Healthcare Spending? It’s the Drugs, New Data Show

    October 9, 2015 — Spending on prescription drugs is propelling overall health care spending, according to the most recent monthly briefing from the Altarum Institute for August 2015. Overall, health spending was up 5.7% in August 2015, from August 2014. While spending increased across all major categories, the biggest increase was in spending on prescription drugs, which rose 9.2% in the same year. This was down from its multi-year high of 14.6% in December 2014; that year-over-year jump reflected both the start of coverage for millions of Americans under the Affordable Care Act (ACA), and the arrival of the new class of hepatitis C drug at the end of December 2013. Read more.


    New Avalere Health Study: Long-Term Care (LTC) Pharmacy Sector Plays Key, Growing Role in U.S. Seniors Care as New Payment, Delivery Models Gain Prevalence

    October 8, 2015 — A new Avalere Health study of the nation’s growing long-term care (LTC) pharmacy sector—the most detailed analysis since Medicare Part D was implemented in 2006—finds LTC pharmacies playing a greater role in senior clinical care, as new health payment and delivery models, such as Accountable Care Organizations (ACOs), bundled payments and value-based purchasing proliferate, amid a rapidly changing health care marketplace. Read more.


    Are the CDC Opioid Guidelines Really Voluntary?

    October 8, 2015 — When is a medical guideline voluntary, and when does it become a “standard of practice” that doctors are expected to follow? That is one of the key questions in the ongoing debate over controversial guidelines for opioid prescribing, unveiled last month by the Centers for Disease Control and Prevention (CDC). Read more.


    Express Scripts Looks to Limit Drug Price Increases

    October 7, 2015 — Express Scripts, the largest pharmacy benefits manager in the U.S., says it’s got a plan to fight drug price increases: Refuse to pay. “We actually have inflation protection, which is really important,” Express Scripts Chief Medical Officer Dr. Steve Miller said in a telephone interview. “What really frustrates employers and other plan sponsors is when you agree to a price, and they just start jacking it up.” Read more.


    The Real Reason U.S. Drug Prices Are So High

    October 7, 2015 — Turing Pharmaceuticals CEO Martin Shkreli became the latest poster boy for Wall Street greed when he jacked up the price of an HIV drug more than 4,000 percent, to $750 a pill. But, the former hedge fund manager’s behavior is far from unique. Dramatic price hikes on existing drugs, or astoundingly high rates for new ones, are common practice in the United States. Read more.


    Telepharmacy’s Bright Future

    October 7, 2015  — At McBride Orthopedic Hospital, a 75-bed, physician-owned specialty surgery facility in Oklahoma City, the adoption of bar-coded drug administration and electronic prescribing, combined with the challenge of medication reconciliation, drove the need for a 24/7 pharmacy. A key feature of McBride’s new pharmaceutical delivery model is an additional pharmacist team, which takes over when the inpatient pharmacy closes at 9:30 p.m., each weeknight. Though this expert staff fills orders from the electronic records system, and is available for a consult instantly by phone, it is fruitless to stop by its office. Read more.


    A New Way to Define Value in Drug Pricing

    October 6, 2015 — Prices for specialty drugs in the United States are out of control, with spending rising much faster than in many other health care domains. Some state Medicaid programs have been driven to the brink by the cost of new drugs for diseases, such as hepatitis C, for which 12 weeks of treatment with Sovaldi can cost nearly $100,000. Read more.


    Retail Pharmacy Project Aims to Boost Vaccination Rates

    October 6, 2015 — A new pilot project aims to boost vaccination rates at community pharmacies nationwide. The Pharmacy Quality Alliance (PQA), in collaboration with VoicePort and Scientific Technologies Corporation (STC), is starting the Immunization Services Model for an Adult Rate Improvement (ImmuSMART) project later this year. Read more.


    The Career Game Changers of Pharmacy

    October 6, 2015 — As a pharmacy educator and adviser to budding pharmacists, I am often asked about the different facets of a pharmacy career—what are all the options, and which one is right for a particular individual? The good news is that the profession has gained a lot of variety in the past 50 years. The challenge lies in understanding the very wide standard deviation of opportunities, and how to properly match up an opportunity to an ideal candidate via strengths and values. Read more.


    CVS/Pharmacy Brings Hearing, Optical Services In-Store

    October 5, 2015 — CVS Health announced it is opening Hearing Centers in seven CVS/pharmacy stores in the Dallas and Cleveland markets, and will be providing optical services at CVS/pharmacy in five store locations around the Baltimore/Washington, D.C. market. Read more.


    Competition Is the Cure

    October 5, 2015 — To lower the insane price of generic drugs, look to the global marketplace. Last week, an obscure prescription drug grabbed attention after its new owner hiked its price a stunning 5,000 percent, from $13.50 to $750 per pill. The drug, called pyrimethamine (branded as Daraprim), cures a lethal disease that afflicts mostly AIDS and cancer patients with weak immune systems. Now, annual treatment can cost hundreds of thousands of dollars. Read more.


    Americans Are Concerned About Drug Costs, Not Obamacare

    October 5, 2015 — The national media have reported on Turing Pharmaceuticals’ 5,000 percent price increase for Daraprim, a treatment for toxoplasmosis. There are numerous other pharmaceutical companies who have taken control of a drug and dramatically increased the price. After reading those stories and reflecting on comments made to me by a close friend and local pharmacist, I asked him to show me examples of price increases that he has seen in the last several years. Read more.


    What Can a Business Coach Do for Your Pharmacy?

    October 1, 2015 — The answer is plenty, according to Topeka Pharmacy, one of the 3,200 pharmacies in AmerisourceBergen’s Good Neighbor Pharmacy network. In a small rural town in northeastern Indiana, Topeka Pharmacy is a destination for its Amish and English population of about 5,000. Tom Miller, RPh, president and owner of this 27-year-old drugstore, and his staff offer patients and customers pharmacy services, clinical consultations, immunizations, diabetes and weight management classes, and a whole lot more. Read more.


    Millions More Need H.I.V. Treatment, W.H.O. Says

    September 30, 2015 — The World Health Organization issued sweeping new guidelines that could put millions more people on H.I.V. drugs than are now getting them. The recommendations could go a long way toward halting the epidemic, health officials say, but would cost untold billions of dollars, not yet committed. Read more.


    How Drug Prices and Payment Reform Are Changing the Pharmacy Benefit Business

    October 26, 2015 — The pharmacy benefit management industry has been quietly changing amid health care payment reforms and an increasingly fierce debate over drug prices. Now a leadership shuffle at the country’s largest pharmacy benefit company has experts speculating that the days of PBMs as stand-alone companies may be numbered. Read more.


    FDA Revokes Approval to Sun Pharma’s Anti Epilepsy Drug

    September 26, 2015 — The U.S. Food and Drugs Administration has withdrawn an approval granted in March to Sun Pharma Advanced Research Company’s (SPARC) anti-epileptic drug, due to regulatory compliance issues at Sun Pharma’s Halol plant. SPARC, which earlier in the week filed a letter of offer with Sebi to raise Rs 250 crore through a rights issue, had received FDA approval for its Elepsia XR tablets (Levetiracetam) in March. Read more.


    National Guideline Clearinghouse Posts First Lyme Disease Treatment Guidelines to Comply with Institute Of Medicine Standards

    September 22, 2015 — Lyme disease treatment guidelines developed by the International Lyme and Associated Diseases Society (ILADS) were posted on the National Guideline Clearinghouse (NGC). They are the first Lyme disease guidelines that comply with the Institute of Medicine’s new standards for rigorous evidence assessment and patient engagement in the development process. Physicians rely on the NGC for trustworthy evidence-based treatment guidelines. Read more.


    Hospital Pharmacy Standards Updated Globally

    September 22, 2015 — The International Pharmaceutical Federation (FIP) has updated the practice standards used by hospital pharmacists worldwide. The standards, known as “Basel Statements,” provide best practices for hospital pharmacists, and are intended to improve pharmacy services and enhance overall quality of care. Read more.


    Specialty Pharmacy Boom Will Continue, CVS Health to Be a Major Beneficiary

    September 21, 2015 — At a time when everybody is worried about economic stasis, health care is one industry that continues to offer growth opportunities that are bigger than ever. Be it pharmaceuticals, insurance, pharmacy benefit management or drug retailing, there is something to offer across verticals. In the U.S., the Affordable Care Act, which is expected to bring more people in under insurance coverage, has created new opportunities in insurance and pharmacy benefit management. Read more.


    Prescription Drug Costs Are Rising as a Campaign Issue

    September 21, 2015 — Both Bernie Sanders and Hillary Rodham Clinton are trying to make the rising cost of prescription drugs an issue in the presidential campaign. Sanders introduced a bill in Congress this month, spelling out a host of policy changes to drive down drug costs. Clinton tweeted that her plan would be released, and her campaign has released some details. Read more.


    How an Obscure Drug’s 4,000% Price Increase Might Finally Spur Action on Soaring Health Care Costs

    September 21, 2015 — Spectacularly high drug prices have become a political punching bag, especially since Turing Pharmaceuticals struck a nerve by increasing the price of a 62-year-old drug by more than 4,000 percent—a mind-boggling increase, similar to waking up one day and finding out a gallon of gas costs nearly $100. Read more.