Clinical Insights: September 22, 2017

    Welcome to the weekly 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

    Solosec™ (secnidazole) – September 18, 2017 – Symbiomix Therapeutics announced the U.S. Food and Drug Administration (FDA) has approved Solosec™ (secnidazole) 2g oral granules for the treatment of bacterial vaginosis (BV) in adult women. Read more.

    Xhance™ (fluticasone propionate) – September 18, 2017 – Optinose, an ENT/Allergy specialty pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) approved the company’s New Drug Application (NDA) for XHANCE (previously referred to by the development name OPN-375) for the treatment of nasal polyps in patients 18 years of age and older. Read more.

    Trelegy Ellipta™ (fluticasone furoate/umeclidinium/vilanterol) – September 18, 2017 – GlaxoSmithKline plc and Innoviva, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved once-daily, single inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI), under the brand name Trelegy Ellipta™, for the long-term, once-daily, maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Read more.

    Adzenys ER™ (amphetamine) – September 15, 2017 – Neos Therapeutics, Inc., announced that the U.S. Food and Drug Administration (FDA) has approved Adzenys ER™ (amphetamine) Extended-Release Oral Suspension. Read more.


    New Formulation Approval

    No new updates.


    New Indication Approval

    Somatuline® Depot (lanreotide) – New Indication Approval – September 18, 2017 – Ipsen announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental indication for Somatuline® Depot (lanreotide) Injection 120 mg for the treatment of carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analogue rescue therapy. Read more.

    Briviact® (brivaracetam) – New Expanded Indication – September 15, 2017 – UCB announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Briviact® (brivaracetam) CV as monotherapy for partial-onset (focal) seizures (POS) in patients 16 years and older with epilepsy. Read more.


    New Drug Shortage

    September 22, 2017

    September 19, 2017


    New Drug Recall and Safety Alerts

    Ocaliva (obeticholic acid) – New Drug Safety Communication – September 21, 2017 – The FDA is warning that the liver disease medicine Ocaliva (obeticholic acid) is being incorrectly dosed in some patients with moderate to severe decreases in liver function, resulting in an increased risk of serious liver injury and death. Read more.

    Opioid Addiction Medications in Patients Taking Benzodiazepines or CNS Depressants – New Drug Safety Communication – September 21, 2017 – Based on additional review, the FDA is advising that the opioid addiction medications buprenorphine and methadone should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system (CNS). The combined use of these drugs increases the risk of serious side effects; however, the harm caused by untreated opioid addiction usually outweighs these risks. Read more.


    New First Time Generic

    Qseltamivir Phosphate (Tamiflu®) Oral Suspension – September 18, 2017 – The first generic version of oseltamivir phosphate for oral suspension 6 mg/mL has received FDA approval. The drug—which comes in 30 mg, 45 mg, and 75 mg doses—is made by Nesher Pharmaceuticals. Read more.


    Clinical and Pharmacy News

    High Gene-Therapy Costs Trigger Call for New Payment Models – September 22, 2017 – The six-figure prices of new gene therapies will require payers, pharma companies, policymakers, and pharmacy benefit managers (PBMs) to develop new payment models that ensure patient access while reflecting the value delivered by the new treatments based on clinical outcomes, a top executive with PBM Express Scripts asserts. Read more. 

    E-Prescribing Allows Pharmacists to Improve Patient Care – September 22, 2017 – Technology has taken hold in nearly every aspect of day-to-day life, even when it comes to healthcare. Increasingly, physicians are forgoing traditional paper forms and opting for a streamlined digital approach. A new survey conducted by the American Society of Health-System Pharmacists (ASHP) found that technology that improves medication use have been implemented in nearly all hospitals in the United States. Read more.

    CVS Pharmacy Will Limit Prescriptions for Opioids – September 22, 2017 – With the 64,000 deaths from opioid overdoses last year alone, the medical community is struggling to contain the out-of-control opioid epidemic. Now, CVS, one the nation’s largest pharmacy benefit managers that oversees prescription drug benefits for 90 million people through its CVS Caremark plan, is attempting to address opioid abuse by no longer reimbursing opioid prescriptions beyond the first week for people filling these prescriptions for the first time. Read more.

    Novartis’s $475,000 Price on Cancer Therapy Meets Resistance – September 22, 2017 – The $475,000 price tag on Novartis AG’s latest breakthrough cancer therapy came under fire from one of the biggest managers of drug costs in the U.S., underscoring the challenges the Swiss drugmaker will face in promoting the potential blockbuster. Read more. 

    High on Drugs? Anthem Cites Soaring Drug Costs to Justify 35 Percent Rate Hike in California – September 22, 2017 – Health insurance giant Anthem predicts Californians will pop a lot more pills next year. To make the case for a hefty premium hike in the state’s individual insurance market, Anthem Blue Cross has forecast a 30 percent jump in prescription drug costs for 2018. Such a sharp increase is nearly double the estimates of two other big insurers, and it runs counter to industry trends nationally. Read more.

    How Will Pharmacists Practice in 2015: A 2017 Response – September 21, 2017 – In 2005, Carol Ukens wrote an article titled “How will Pharmacists Practice in 2015?” It is now 2017, and as an accompaniment, this article will look to both answer that question and hypothesize the future of the profession. Read more.

    Statement from FDA Commissioner Scott Gottlieb, M.D., On the Agency’s Continued Efforts to Promote the Safe Adoption of Medication-Assisted Treatment for Opioid Addiction – September 20, 2017 – Medication-assisted treatment (MAT) – the use of medication combined with counseling and behavioral therapies – is one of the major pillars of the federal response to the opioid epidemic in this country. This type of treatment is an important tool that has the potential to help millions of Americans with an opioid use disorder regain control over their lives. Read more. 

    Amazon is Taking on The Drug Supply Chain, Says Report – September 20, 2017 – Amazon is ramping up conversations with a group of drug middlemen known as pharmacy benefits managers or PBMs, according to analysts from Leerink Partners. PBMs are a critical part of the drug supply chain, as they negotiate prices with drug manufacturers on one end, and manage pharmacy benefits for insurers on the other. Read more.

    Preventing Medication Errors in Pharmacy – September 20, 2017 – Medication errors are common in pharmacy, but mistakes can lead to severe consequences, ranging from illness to death. Unintentional harming of patients is avoidable and there are ways to ensure it doesn’t happen. Read more.

    How Pharmacy Benefit Managers Lower Prescription Drug Prices – September 19, 2017 – Payers in both the private and public sectors require new strategies that offset the rising cost of prescription drugs. Pharmacy benefit managers (PBMs) are professionals that administer prescription drug plans for payers, employers, and CMS programs with the goal of lowering prescription drug costs, improving convenience, and ensuring patient safety for payers and their beneficiaries. Read more.

    FDA Considers Compounding Pharmacy Regulations – September 19, 2017 – This is according to a Reuters interview with FDA commissioner Scott Gottlieb, who said that the agency is working toward a policy aimed at encouraging more compounding pharmacies to register under the Drug Quality and Security Act (DQSA). The DQSA was passed in the wake of the New England Compounding Center meningitis outbreak—for which owner Barry Cadden was sentenced to nine years in prison. Read more.

    Physicians, Patients Blame Insurance, Drug Companies for Rising Healthcare Costs – September 19, 2017 – Physicians and healthcare consumers all blame insurance companies, drug companies and medical device manufacturers for rising healthcare costs, according to results of a new nationwide survey produced by the Texas Medical Center Health Policy Institute in Houston. Read more.

    Costly Drugs to Weigh on U.S. Employers’ Expenses In 2018: Survey – September 18, 2017 – U.S. employers are bracing for higher healthcare expenses in 2018 as spending on new drugs to treat diseases such as cancer, multiple sclerosis and hepatitis C is expected to rise more than 7 percent, according to consultancy firm Mercer. Read more. 

    2017 Guidelines for Chronic Pain Management in Patients with HIV – September 18, 2017 – Patients with HIV should be assessed for chronic pain and offered pain management options, according to recently-published guidelines released by the HIV Medicine Association (HIVMA) of the Infectious Diseases Society of America (IDSA). Read more.


    340B in the News

    Apexus Advanced 340B Operations Certificate Program Wins Brandon Hall Group Bronze Award for Best Advance in Compliance Training – September 22, 2017 – Apexus, the nation’s leading authority on the 340B Drug Discount Program, has won the Brandon Hall Group Bronze Award for Best Advance in Compliance Training for the Apexus Advanced 340B Operations Certificate Program. Read more.

    A Third of Rural Hospitals at Risk for Closure; Extension of Federal Programs Could Provide Relief – September 22, 2017 – A third of rural hospitals are at risk for closure, and those closures have a ripple effect on rural communities. Diane Calmus, government affairs and policy manager for the National Rural Health Association, said in an interview with AgriTalk that the financial struggles of rural hospitals have far-reaching impacts on the communities they serve. Read more.

    Rural Hospitals Are Already Struggling to Keep Their Doors Open – September 21, 2017 – The area I represented in Congress is the most rural in America. It spans hundreds of square miles in south and west Texas. Some towns were almost four hours from the nearest airport. In others, it might take law enforcement two hours to respond to a call. To most of my people, rural hospitals were their only hope for healthcare needs. Read more. 

    Viewpoint: Hospitals Need 340B More Than Ever – September 20, 2017 – Hospitals are essential for the people they serve. Nowhere is that more relevant than among North Dakota’s rural hospitals, which have limited resources, poor staff retention, recruitment problems, and insufficient Medicare and Medicaid reimbursement rates. Read more. 

    Rural Hospitals Struggle to Stock Rare Disease Drugs Blocked From 340B Discounts – September 18, 2017 – Rural hospitals often struggle to keep expensive rare disease drugs stocked and available for patients, since they must pay full price for the medications through the 340B Drug Discount Program, reports NPR. The ACA added rural hospitals to the drug discount program in 2010. However, a last minute exclusion written into the legislature prevents rural hospitals from receiving discounts for rare disease drugs, according to the report. Rare disease drugs, also known as orphan drugs, are used to treat a disease affecting fewer than 200,000 Americans and often cost $100,000 a year or more. Read more.

    Rural Hospitals Continue to Struggle to Pay for Lifesaving Drugs – September 18, 2017 – Hospital pharmacist Mandy Langston remembers when Lulabelle Berry arrived at Stone County Medical Center’s emergency department last year. Berry couldn’t talk. Her face was drooping on one side. Her eyes couldn’t focus. Read more.

    340B Program Provides Necessary Care and Cures – September 17, 2017 – You might guess that the big state of Texas has the largest rural population in America, but did you know that our state ranks a very close second? North Carolina has the second-largest rural population in the nation, with 80 rural counties having an average population of fewer than 250 people per square mile. Such generous spacing means that many face serious challenges when attempting to secure medical attention. Read more.