Clinical Insights: May 1, 2018

    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

    JynarqueTM (tolvaptan) – April 24, 2018 – Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that the U.S. Food and Drug Administration (FDA) has approved JynarqueTM (tolvaptan) as the first drug treatment to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). Read more.

    Akynzeo® for Injection (fosnetupitant and palonosetron) – April 20, 2018 – Helsinn announced that the U.S. Food and Drug Administration (FDA) has approved the intravenous formulation of Akynzeo® (NEPA, a fixed antiemetic combination of fosnetupitant, 235mg, and palonosetron, 0.25mg) as an alternative treatment option for patients experiencing CINV. The FDA has approved Akynzeo® IV in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. RxS Clinical Insights: Akynzeo® IV was approved by new drug application (NDA). Previously approved Akynzeo® capsules contain a different formulation of (netupitant and palonosetron). Read more.


    New Formulation Approval

    No new updates.


    New Indication Approval

    Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) – New Expanded Indication – April 24, 2018 – GlaxoSmithKline plc and Innoviva, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC/VI’), which means this medicine can now be used by U.S. physicians to treat a broader population of chronic obstructive pulmonary disease (COPD) patients with airflow limitation or who have experienced an acute worsening of respiratory symptoms. Read more.


    New Drug Shortage

    April 27, 2018 

    April 25, 2018 


    New Drug Recall and Safety Alerts

    lamotrigine (Lamictal) – New Drug Safety Alert – April 25, 2018 – The Food and Drug Administration (FDA) is warning that the medicine lamotrigine (Lamictal) for seizures and bipolar disorder can cause a rare but very serious reaction that excessively activates the body’s infection-fighting immune system. This can cause severe inflammation throughout the body and lead to hospitalization and death, especially if the reaction is not diagnosed and treated quickly. Read more.


    New Generic Launch

    No new updates.


    Clinical and Pharmacy News

    Does 24-Hour Ambulatory BP Monitoring Represent an Opportunity? – April 30, 2018 – A recent study in the New England Journal of Medicine (NEJM) highlighted the value of ambulatory blood pressure (BP) monitoring over in-clinic assessments. Essentially, researchers in Spain ran a study from 2004 to 2014 in which almost 64,000 patients were assessed to determine whether 24-hour ambulatory BP data compared with clinic measurements had any significant difference in predicting all-cause and cardiovascular mortality. Read more.

    Opioid Epidemic: Why Aren’t Prescription Drug Monitoring Programs More Effective? – April 30, 2018 – Long before the opioid epidemic was thought to be a public health emergency, prescription drug abuse and misuse were steadily increasing in the U.S. To combat this, states and hospitals have been building technological platforms to enable prescription drug monitoring programs that can the track habits of both prescribers and patients. But use of PDMPs varies by state, with some states mandating its use and others merely recommending that hospitals and medical groups opt-in. Read more.

    How ACOs can Use Pharmacists for Wellness Coaching, Engagement – April 30, 2018 – In accountable care organizations (ACOs), fostering overall patient health requires high-touch patient wellness coaching. For ACOs facing the surmounting pressure to spark patient health behavior change, integrating pharmacists as another part of the clinician team is essential. Read more.

    Researchers Identify How Smaller Hospitals Can Reduce Inappropriate Use of Antibiotics – April 30, 2018 – Researchers at Intermountain Healthcare and University of Utah Health in Salt Lake City have completed a study identifying how community hospitals with fewer than 200 beds can develop antibiotic stewardship programs that work to prevent the growth of antibiotic-resistant organisms, or “superbugs,” which are becoming more common and deadly. Read more.

    Sterile Compounding Needs Risk Management: Access, Reconstitution or Preparation, and Administration – April 29, 2018 – Whether in an institutional or clinical setting, a large group practice or pharmacy or a collaborative practice, there are increasing implications for legal risks to medical executive committees or P&T committees for duties executed while delivering services to patients. Although there are many, one current area for risk management attention is compounding, which also includes hazardous drugs (HDs) and their administration. Read more.

    New Guideline: Start Taking MS Drugs Early On – April 27, 2018 – For most people, it’s better to start taking drugs for multiple sclerosis (MS) early on rather than letting the disease run its course, according to a new guideline for treating MS from the American Academy of Neurology. Read more.

    Why Limited Distribution in Specialty Pharmacy? – April 27, 2018 – In many drug product releases, especially in the world of specialty pharmaceuticals, manufacturers will often limit the number of specialty pharmacies that can dispense their medications. Pharmaceutical manufacturers will determine this distribution strategy based on product characteristics, education for the patient, market reach and administration and dispensing characteristics. Read more.

    Medicare Part D to Focus on Opioid Prescribing, Revised Star Measures – April 27, 2018 – Medicare Part D payment changes, in 2019, will further clamp down on high-risk opioid use and prescribing, and will shift additional drug coverage liability to manufacturers, an expert told attendees of the Academy of Managed Care Pharmacy’s 2018 Managed Care & Specialty Pharmacy annual meeting. Read more.

    Specialty Drug Spending Grows While Traditional Medicine Spending Drops – April 26, 2018 – The balance of medication spending is strongly shifting from traditional to specialty drugs, which will continue over the next several years, according to a new report by the IQVIA Institute. The report, titled Medicine Use and Spending in the U.S., found that overall medication spending increased by 0.6 percent in 2017 after off-invoice discounts and rebates, including spending on all types of medications. Read more.

    Drug Co-Pay Groups: Critical Patient Charities or Fronts for Drugmakers? – April 26, 2018 – Co-payment assistance groups, created to help patients with the increasingly higher price of drugs to treat medical conditions, are under investigation by federal authorities for possibly skewing the cost of healthcare to favor drug companies. Read more.

    How High Drug Prices and Big Lobbying Budgets Go Together for Big Pharma – April 26, 2018 – The outlook was grim for Novo Nordisk at the end of 2016. As pressure mounted over the pharmaceutical giant’s rising insulin prices, investors drove its stock down by a third, fearing that policymakers would cap price tags and hurt profits. Read more.

    Clinical Pharmacists Are an Option for Chronic Disease Management – April 26, 2018 – Anyone managing patients with chronic medical conditions understands the importance of medication management and adherence. Most providers, however, have little time to deal with these issues. A possible solution is working with a clinical pharmacist. Read more.

    Pharmacists and Patients Partner for Better Home BP Monitoring – April 26, 2018 – The American Heart Association recommends home blood pressure monitoring for all patients with hypertension, and with good reason: studies show that home blood pressure monitoring can improve outcomes and medication adherence. Yet overall, more than one-half of Americans with hypertension do not meet treatment goals, suggesting a need for more education. Read more.

    The Role of PBMs in the Drug Supply Chain — And Why it Matters to Employers – April 25, 2018 – Over the last decade, the pharmacy benefit management industry has been on an extended run of mergers, acquisitions, consolidation and cross-industry partnerships. But this flurry of activity hasn’t necessarily been for the benefit of consumers and employers. In fact, the current PBM system is not aligned to drive cost savings, value and transparency for employers and consumers. Read more.

    Drug Pricing Proposal Should Revamp Medicare, GOP Experts Say – April 25, 2018 – An upcoming Trump administration proposal on lowering drug costs should ask Congress to allow private insurance companies to negotiate prices for drugs administered in a doctor’s office or hospital, two Republican policy experts said. Read more.

    How New Guidelines for High Blood Pressure Could Harm Some Patients – April 24, 2018 – The new guidelines for categorizing patients with hypertension is causing blood pressure to rise among some experts involved in the debate. Late last year, the American College of Cardiology, along with the American Heart Association, lowered the threshold for defining high blood pressure as well as the threshold for drug treatment in some patients. Read more.

    Medication Keeps Getting More Expensive—And Big Pharma Won’t Explain Why – April 24, 2018 – When Martin Shkreli, former CEO of Turing Pharmaceuticals, raised the price of Daraprim, which treats dangerous infections, from $13.50 to $750, the public was appalled. Read more.

    NACDS Applauds Congress’ DIR Fee Reform Letter – April 23, 2018 – The National Association of Chain Drug Stores announced its support for a letter written to Health and Human Services Secretary Azar, which was written and signed by 50 members of the U.S. House of Representatives and led by Rep. Tom Marino and David Loebsack. Read more.

    Specialty Medications Drive New Drug Spending – April 23, 2018 – Specialty medicines drove $9.8 billion of the $12 billion in spending on new (on the market less than 24 months) medicines in 2017, according to a new report released from the IQVIA Institute for Human Data Science. Of the 42 New Active Substances released in 2017, 32 of those were specialty medications. Read more.

    Opioid Shortage in Hospitals Expected to Last Through the Summer – April 23, 2018 – The critical shortage of a number of injectable opioid medications, including morphine, hydromorphone and fentanyl, continues to plague hospitals—leaving pharmacy directors and managers scrambling to come up with alternative sources and agents for use in surgery and pain management. Read more.

    Bigger Role for Pharmacists can Help Primary Care Docs – April 23, 2018 – Pharmacists can be a useful and cost-effective addition to primary care practices, Hae Mi Choe, PharmD, said here American College of Physicians annual meeting. Read more.


    340B in the News

    Medicare Part B Payment Cuts, 340B Growth Blamed for Oncology Clinic Closures – April 30, 2018 – More than 1,200 independent oncology clinics have either closed or been acquired by hospitals in the last decade, and oncologists blame the 340B program and Medicare Part B for the consolidation. Read more.

    The 340B Program – A Lifeline for Vulnerable Alabama Patients – April 25, 2018 – East Alabama Medical Center (EAMC) is an invaluable source of healthcare for some of the neediest members of our community. We are a Disproportionate Share Hospital (DSH) – a federal designation reflecting EAMC’s treatment of a large percentage of indigent patients, many of whom are uninsured or underinsured. In fact, more than 60 percent of the patients we see each day either are dependent on public health assistance or have no health insurance at all. Read more.

    K&L Gates Triage: 340B Update: State Medicaid 340B Billing Requirements – April 25, 2018 – In the midst of the ongoing federal conversation surrounding the 340B Drug Pricing Program, individual states are implementing a number of regulatory efforts related to the 340B Program at an increasingly fast pace. These efforts are largely designed to avoid duplicate discounts, capture Medicaid drug rebates and reduce reimbursement for 340B drugs. Read more.

    House Bill Aims to Add ‘Layer of Transparency’ To 340B Program: 5 Things to Know – April 25, 2018 – U.S. Rep. Earl “Buddy” Carter, R-Ga., introduced legislation April 24 that would require hospitals participating in the 340B Drug Pricing Program to report their low-income utilization rates for outpatient and inpatient services. Read more.

    House Bill Would Add Reporting Requirements For 340B Hospitals – April 24, 2018 – A House Republican on Tuesday unveiled a proposal that would require hospitals participating in the 340B Drug Discount Program to disclose how much care they provide to low-income patients. But healthcare stakeholders warn the bill could place unfair reporting burdens on providers in medically vulnerable communities. Read more.

    Congress Must Protect Vital Discount Drug Program – April 24, 2018 – For more than 376,000 Connecticut residents each year, their medical needs are provided by a federally qualified health center, a community health center that gives patients top-level primary, dental, and behavioral healthcare at a fraction of the cost of an emergency room visit. Read more.