RxStrategies Clinical Insights — November 2015, Issue 2

    Welcome to the second 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

    Ninlaro® (ixazomib)

    November 20, 2015 – The U.S. Food and Drug Administration approved ixazomib (Ninlaro®, Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited) in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.  Ixazomib is the first approved oral proteasome inhibitor. Read More.



    November 16, 2015 – The U.S. Food and Drug Administration granted accelerated approval to daratumumab injection (Darzalex™, Janssen Biotech, Inc.), administered as a single agent for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent. RxS Clinical Insight: Darzalex (daratumumab) is approved with Orphan drug status. Read More


    Tagrisso (osimertinib)

    November 13, 2015 – The U. S. Food and Drug Administration granted accelerated approval to osimertinib (Tagrisso™) once daily tablets, AstraZeneca Pharmaceuticals LP, for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy. RxS Clinical Insight: Tagrisso (osimertinib) is approved with Orphan drug status. Read More.


    Cotellic (cobimetinib) 

    November 10, 2015 – The U.S. Food and Drug Administration approved cobimetinib (Cotellic™ Tablets, Genentech, Inc.) for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib.  Cobimetinib is not indicated for treatment of patients with wild-type BRAF melanoma. Read More.


    Nucala® (mepolizumab) 

    November 4, 2015 – The U.S. Food and Drug Administration approved Nucala® (mepolizumab) for use with other asthma medicines for the maintenance treatment of asthma in patients age 12 years and older. Nucala® is approved for patients who have a history of severe asthma attacks (exacerbations) despite receiving their current asthma medicines. Read More.


    New Formulation Approval

    Narcan® Nasal Spray (naloxone) 

    November 19, 2015 – Adapt Pharma Limited announced that the U.S. Food and Drug Administration has approved Narcan® (naloxone hydrochloride) Nasal Spray for the emergency treatment of known or suspected opioid overdose. Read More.


    Adynovate® (antihemophilic factor (recombinant) pegylated) 

    November 13, 2015 – The U.S. Food and Drug Administration approved Adynovate®, Antihemophilic Factor (Recombinant), PEGylated for use in adults and adolescents, aged 12 years and older, who have Hemophilia A. Adynovate® is modified to last longer in the blood and potentially require less frequent injections than unmodified Antihemophilic Factor when used to reduce the frequency of bleeding. Read More.


    Genvoya® (elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide)

    November 5, 2015 – The U.S. Food and Drug Administration approved Genvoya® (a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older. Read More.


    Utibron™ Neohaler® (glycopyrrolate)

    October 29, 2015 – Novartis announced that the US Food and Drug Administration has approved the dual combination bronchodilator Utibron™ Neohaler® (indacaterol/glycopyrrolate) inhalation powder for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is not indicated to treat asthma or sudden symptoms of COPD. Read More.


    Seebri™ Neohaler® (glycopyrrolate)

    October 29, 2015 – The FDA approved Seebri™ Neohaler® (glycopyrrolate) inhalation powder 15.6 mcg – which is one component of Utibron Neohaler® – as a stand-alone monotherapy for the same COPD indication. Read More.


    New Indication Approval

    Opdivo® (nivolumab) – New Indication

    November 23, 2015 – The U.S. Food and Drug Administration approved Opdivo® (nivolumab) to treat patients with advanced (metastatic) renal cell carcinoma, a form of kidney cancer, who have received a certain type of prior therapy. Opdivo® works by targeting the cellular pathway known as PD-1/PD-L1 (proteins found on the body’s immune cells and some cancer cells). By blocking this pathway, Opdivo® may help the body’s immune system fight cancer cells. Opdivo® is intended for use in renal cell carcinoma in patients who have received prior anti-angiogenic therapy (treatments that interfere with the blood vessels that contribute to the growth of cancerous cells).
    Read More.


    Harvoni® (ledipasvir/sofosbuvir) – Expanded Indication

    November 12, 2015 – Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration has approved Harvoni® (ledipasvir/sofosbuvir) for expanded use in patients with genotype 4, 5 and 6 chronic hepatitis C virus (HCV) infection and in patients co-infected with HIV. In addition, Harvoni® plus ribavirin (RBV) for 12 weeks was approved as an alternate therapy to 24 weeks of Harvoni® for treatment-experienced, genotype 1 patients with cirrhosis. Read More.


    New Drug Shortage

    November 23, 2015

    November 20, 2015

    November 17, 2015

    November 10, 2015

    October 29, 2015


    Drug Safety Alert

    Plavix® (clopidogrel) 

    November 6, 2015 –  An FDA review has determined that long-term use of the blood-thinning drug Plavix® (clopidogrel) does not increase or decrease overall risk of death in patients with, or at risk for, heart disease. FDA evaluation of the Dual Antiplatelet Therapy (DAPT) trial and several other clinical trials also does not suggest that clopidogrel increases the risk of cancer or death from cancer. Read More.


    Drug Recall Alert

    Auvi-Q® (epinephrine injection, USP) 

    October 28, 2015 – Sanofi US is voluntarily recalling all Auvi-Q® (epinephrine injection, USP). The recall involves all Auvi-Q® currently on the market and includes both the 0.15 mg and 0.3 mg strengths for hospitals, retailers and consumers. This includes lot number 2299596 through 3037230, which expire March 2016 through December 2016. The products have been found to potentially have inaccurate dosage delivery. Read More.


    Clinical and Pharmacy News

    Obamacare to Blame for Soaring Drug Costs: AEI

    November 24, 2015 – Americans concerned about not being able to afford life-saving treatments should not blame drug companies for high prices, a former health advisor to George W. Bush said Tuesday. Dr. Scott Gottlieb of the conservative American Enterprise Institute told CNBC’s “Squawk Box” there’s not really a drug cost problem in the U.S., except for a small subset of specialty drugs that cost a lot but are providing a lot of benefit. “What we have is an under-insurance problem,” he said. “People are now under-insured, especially for catastrophic drugs if they get a disease like cancer or something like that because of these new [narrow] formulary designs … popularized by the Affordable Care Act.” Read More.


    Doctors Should Prescribe Generic Drugs Over Branded Medications, Say Experts

    November 24, 2015 – In a new report, the American College of Physicians call for all doctors to prescribe generic medications over brand-name drugs, where possible, in order to improve treatment adherence and reduce health care spending. Read More. 


    Risk of Off-Label Uses for Prescription Drugs

    November 23, 2015 – About 12% of drugs doctors prescribe are for uses other than those approved by regulators, a recent study found. So-called off-label prescribing significantly raises the rate of negative side effects, the research showed. Doctors are free to prescribe medications off-label, and in some cases patients benefit from those prescriptions. Physicians may find that an off-label drug is more effective at treating a problem than medications specifically approved for that use. Read More.


    Pharmacy Chains Offer Discounts in Exchange for Your Personal Health Data

    November 23, 2015 – You should probably pay the few extra bucks to keep your data safe. Apps and gadgets have made many of us obsessed with quantifying our health. And while there’s good reason to keep that information away from prying corporate eyes, pharmacies are finding new ways to incentivize customers to share that valuable data. This month, Walgreens has become the latest pharmacy chain to launch an app that gives customers small discounts in exchange for access to their digital health trackers (CVS has a similar program). And while this might be tempting especially for low-income patients, the information these companies are asking for is far too valuable to share for just a couple of dollars off. Read More.


    Pfizer’s Tax-Avoiding Megamerger with Allergan Sparks Outcry

    November 23, 2015 – A $160 billion megamerger announced Monday would turn U.S. pharmaceutical behemoth Pfizer Inc. into an Irish drug company, using a controversial tactic that allows companies to dodge billions of dollars in corporate taxes by renouncing their U.S. citizenship. Read More.


    Concerns Over Valeant Spread to Other Drug Makers

    November 22, 2015 – As questions mount about the viability of Valeant Pharmaceuticals International Inc.’s business model, concerns are spreading to other drug makers seen as following a similar playbook. Like Valeant, the firms are part of a new breed of pharmaceutical company that has limited costly investment in research and development and instead sought sales growth through debt-fueled acquisitions—often of older drugs for which they raise prices sharply. In recent years, the companies’ share prices surged as many investors embraced their business models. Read More. 


    Strategies to Overcome the Readmission Crisis in Health Systems

    November 20, 2015 – Health care is in the midst of a transformation in which health care providers are increasingly being paid for value provided rather than per service. Moreover, the payment implications of hospital readmissions are a major challenge facing hospitals and health systems in this changing landscape. With the advent of the Patient Protection and Affordable Care Act (ACA), hospital readmissions are at the forefront of “crises” demanding meaningful (and efficient) solutions. Read More.


    Pharmacy, PBM Stakeholders Testify on Marketplace Competition

    November 20, 2015 – CVS Health, Express Scripts, and the National Community Pharmacists Association (NCPA) were among the stakeholders to recently testify on the state of competition in the pharmacy benefit manager (PBM) and pharmacy marketplace. The US House Judiciary Committee’s Subcommittee on Regulatory Reform, Commercial and Antitrust Law conducted a hearing on this topic to evaluate negotiation and pricing practices in the pharmacy industry. Read More.


    Novartis Admits to Valeant-like Pharmacy Scheme in $390 Million Settlement

    November 20, 2015 – November 20, 2015 – It’s a sign that Valeant, also under scrutiny for its use of specialty pharmacies, could also have to pay up. Swiss pharmaceutical company Novartis paid $390 million to settle charges that it gave kickbacks to U.S. specialty pharmacies in order to increase sales of its drugs, federal prosecutors said Friday. Read More.


    Administration Is Seeking Ways to Keep Prescription Drugs Affordable

    November 20, 2015 – The Obama administration began building a political case Friday for government actions to protect people against high pharmaceutical costs, saying millions of Americans were unable to afford lifesaving prescription drugs. “As costs go up, so does everyone’s anxiety about their continued access to their prescription medicine,” said Andrew M. Slavitt, the acting administrator of the federal Centers for Medicare and Medicaid Services. He spoke at a daylong forum the administration held to solicit ideas from consumer advocates, doctors, drugmakers, insurers and employers. Read More.


    New Hep C Guidelines Endorse Direct-Acting Anti-Viral Agents

    November 19, 2015 – Nearly all patients with chronic hepatitis C virus (HCV) infections should receive direct-acting anti-viral agents, according to updated guidelines by the American Association for the Study for Liver Diseases and the Infectious Diseases Society of America. Read More.


    American Medical Association Urges Ban On TV Drug Ads

    November 19, 2015 – If one of doctors’ largest lobbying groups has its way, the sun will soon set on the digitally-enhanced world of bright blue skies and fluffy clouds occupied by smiling patients in TV drug ads. The American Medical Association voted this week in favor of a ban on such direct-to-consumer (DTC) advertising of prescription drugs and medical devices. Read More.


    Prescription Drugs and The Slowdown in Health Care Spending

    November 18, 2015 – Several studies have examined the underlying sources for the recent slowdown in health care spending. These analyses have focused largely on the role of the 2007-2009 recession, the increasing prevalence of high deductible health insurance plans, and other structural changes in the payment and delivery of care. However, the studies examining these factors do not account for the full decline in spending, or raise questions about the pattern and timing of the slowdown. Read More.


    New Report Urges More Transparency into PBM Corporations

    November 17, 2015 – A new report by a leading health care policy consulting firm describes the large and expanding role of pharmacy benefit management (PBM) corporations and explores areas that stakeholders have identified as needing greater oversight of and disclosure by these entities. Applied Policy, L.L.C. examined the influence of PBM corporations at the request of the National Community Pharmacists Association (NCPA). The resulting report, “Concerns Regarding the Pharmacy Benefit Management Industry,” provides an overview of three legislative and regulatory concerns that legislators, policymakers, customers, and pharmacies have raised regarding the PBM industry. Read More.


    Big Three PBMs Cut Loose More Specialty Pharmacies as Scrutiny Grows

    November 16, 2015 – Pharmacy benefit managers have broadened their crackdown on specialty pharmacies, with at least 8 cut off from reimbursement in recent days. The PBMs are targeting pharmacies with close ties to particular drugmakers, saying the relationships favor brands over generics, jacking up health spending and running afoul of their own reimbursement rules. Read More.


    5 Drugs That Are the Face of Prescription Drug Reform

    November 15, 2015 – Congress is cracking down on rising prescription drug costs, and these five therapies could prove to be the face of that reform. Although Congress has taken a particular interest in certain drug developers over the past two months following privately held Turing Pharmaceuticals’ attempt to raise the price on a rare-disease drug it acquired by nearly 5,500% overnight, passing along hefty price increases to insurers and consumers has long been a way of life for drug developers. Read More.


    Pharmacy Interventions Improve Adherence for Patients on New Meds

    November 12, 2015 – Pharmacy interventions for patients taking new medications can improve adherence, reduce health care costs and improve outcomes. Walgreens recently released a study that analyzed patients who received pharmacy interventions compared with a control group of patients who did not go to Walgreens and did not receive any pharmacy interventions. The patients in the 6-month study were starting new medications across 16 drug classes. Interventions included pharmacist consultations by phone or in person and reminders for prescription refills and pick-up through calls, texts, and emails. Read More


    ACR Releases 2015 Guideline For Treatment Of Rheumatoid Arthritis

    November 11, 2015 – The American College of Rheumatology (ACR) released its 2015 Guideline for the Treatment of Rheumatoid Arthritis (RA) during the 2015 ACR/ARHP Annual Meeting in San Francisco. An early draft of the recommendations was presented at last year’s meeting in Boston, and the final recommendations are now available on the ACR website. The guideline is designed for use by both rheumatologists and other clinicians for pharmacologic treatment decisions in commonly encountered clinical situations. Read More 


    More Orders Per Shift Linked to Medication Errors, Says AJHP Study

    November 10, 2015 – The demanding workload on pharmacists is a reality many know too well. Now a new study links the amount of orders verified by health-system pharmacists to the frequency of medication errors. The study, published in the American Journal of Health-System Pharmacy (AJHP), found that an increase in the number of orders verified per shift was associated with an increased rate of pharmacist errors during order verification in a tertiary-care medical center. Read More.


    3 Things to Know About the Sprint Blood Pressure Trial

    November 9, 2015 – New data from a major study called Sprint has shaken some of the basic assumptions about the treatment of high blood pressure. The trial found that lowering systolic blood pressure from currently recommended levels of 140 to 150 to below 120 could prevent heart attacks and strokes and potentially save many lives.
    Read More. 


    Target Loses Latest Round in Effort to Prevent Pharmacy Workers From Forming Union

    November 5, 2015 – Target Corp has lost another round in its attempt to prevent pharmacy workers at a New York City store forming what would be the first union in the retailer’s 113-year history after a U.S. labor agency declined to review its objections to the plan. In a single-sentence ruling on Wednesday, the National Labor Relations Board declined to review Target’s claim that board lawyers erred in approving the creation of the union because the company is in the process of selling its pharmacy operations to CVS Health Corp. Read More.


    With Help from Pharmacists, Better Blood Pressure Costs $22

    November 4, 2015 – A pharmacist–physician collaborative effort to control blood pressure among a diverse group of patients was considered cost-effective, with a $22 price tag to increase the hypertension control rate by 1% (Hypertension 2015 Nov 2). Read More.


    Nearly 60 Percent of Americans – The Highest Ever – Are Taking Prescription Drugs

    November 4, 2015 – Nearly 3 in 5 American adults take a prescription drug, up markedly since 2000 because of much higher use of almost every type of medication, including antidepressants and treatments for high cholesterol and diabetes. In a study published Tuesday in the Journal of the American Medical Association, researchers found that the prevalence of prescription drug use among people 20 and older had risen to 59 percent in 2012 from 51 percent just a dozen years earlier. Read More.


    Top 5 Facts Pharmacists Should Know About Biosimilars

    November 4, 2015 – Considerable confusion surrounds the new world of biosimilar drugs. Erika Lietzan, JD, associate professor at the University of Missouri School of Law, provided some legal guidance for pharmacists and physicians during a recent Wolters Kluwer Clinical Drug Information webinar. Here are the top five issues connected with biosimilars that pharmacists should know about. Read More


    Can Hospitals Waive the Costs Of Certain Drugs?

    November 3, 2015 – Federal laws and regulations generally frown on hospitals providing Medicare patients with free or discounted medications, but a recent policy statement from the OIG appears to buck that trend. From now on, hospitals won’t face any administrative sanctions for waiving or discounting self-administered drugs (SADs) that are either administered or ingested in an outpatient setting and aren’t covered under Medicare Part B. Read More.


    Hospital Pharmacists Increasingly Involved in Direct Patient Care

    November 1, 2015 – Pharmacy continues to respond to the needs of patients and the health-care system. That’s a key theme in results of the 2014 American Society of Health-System Pharmacists (ASHP) national survey of pharmacy practice in hospital settings that pertain to dispensing and administration, according to a recent practice report in the American Journal of Health-System Pharmacy. Read More.



    340B in the News

    Taking The Chains Off 340B

    November 5, 2015 – Regulators have taken an important first step toward reforming one of the federal government’s most widely abused health initiatives: the 340B Drug Pricing Program. The Health Resources and Services Administration just released a guidance proposal that could, at long last, strengthen oversight for the program. HRSA’s attempted reforms come as promising news to independent pharmacies, which have suffered from large health care providers’ abuse of 340B in recent years. Read More.


    Ensure 340B Program Is About Patients, Not Hospital Profits

    November 20, 2015 – There is no question the 340B drug discount program provides a critical safety net for America’s most vulnerable patients; especially those served by disproportionate share hospitals, federally qualified health centers, and safety net providers, such as Ryan White HIV/AIDS clinics. But what started in 1992 as a relatively small prescription drug discount program for qualifying facilities has exploded in size due to the participation of hospitals that often deliver relatively little charity care.
    Read More.


    Rural Hospitals at Risk

    November 19, 2015 – any rural American hospitals are struggling to keep their doors open in the face of rising costs. Fifty-eight have closed since 2010 and many more may follow if the pharmaceutical industry gets its way and dismantles a little-known federal drug discount program called 340B. Read More.


    HSCA Comments on HRSA 340B

    November 12, 2015 – The Healthcare Supply Chain Association (HSCA) filed comments in response to the U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration’s (HRSA) proposed draft guidance “340B Drug Pricing Program Omnibus Guidelines.” The comments focus on easing burdens on healthcare providers under the proposed guidance’s group purchasing organization (GPO) prohibition provision in a manner consistent with the program’s purpose – to enable covered entities to stretch scarce federal resources and reach more eligible patients. Read More.


    Provider-Based Status: A Quiet Casualty of the Bipartisan Budget Act

    November 2, 2015 – Without fanfare or any significant discussion, the Bipartisan Budget Act contains the first legislative action related to provider-based status—and it is a sweeping action with negative financial consequences to many hospitals. The Senate passed the Act early this morning, and it is headed to the President for signature. The changes take effect on the day President Obama signs the Act, which is expected to be November 2, 2015. Read More.