Clinical Insights: February 5, 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

    FirvanqTM (vancomycin hydrochloride) – January 29, 2018 – CutisPharma announced that the U.S. Food and Drug Administration (FDA) has approved Firvanq™ (vancomycin hydrochloride) for oral solution, for the treatment of Clostridium difficile associated diarrhea and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains. Read more.

    Lutathera® (lutetium Lu 177 dotatate) – January 26, 2018 – The Food and Drug Administration approved lutetium Lu 177 dotatate (LUTATHERA®, Advanced Accelerator Applications USA, Inc.) a radiolabeled somatostatin analog, for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut and hindgut neuroendocrine tumors in adults. Read more.


    New Formulation Approval

    No new updates.


    New Indication Approval

    Avycaz® (ceftazidime and avibactam) – February 1, 2018 – Allergan plc announced that the U.S. Food and Drug Administration (FDA) has approved Allergan’s supplemental New Drug Application (sNDA) to expand the approved use of Avycaz® (ceftazidime and avibactam) to include the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible Gram-negative microorganism. Read more.

    Trulance® (plecanatide) – January 25, 2018 – Synergy Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Trulance® (plecanatide) 3 mg tablet for the once-daily treatment of irritable bowel syndrome with constipation (IBS-C) in adults. This is the second indication for Trulance®, which is already approved for the treatment of adults with chronic idiopathic constipation (CIC). Read more.


    New Drug Shortage

    February 2, 2018 

    January 26, 2018 

    January 25, 2018 

    January 24, 2018 

    January 23, 2018 


    New Drug Recall and Safety Alerts

    Gericare Eye Wash by Kareway Products – Drug Recall Alert – February 2, 2018 – Kareway Products, Inc. is voluntarily recalling 60,000 lots of Gericare Eye Wash, Sterile Eye Irrigation Solution, four fluid ounces to the hospital, retail or consumer level. The product has been found to have potential microbial contamination which compromises sterility. Read more.

    Ocaliva® (obeticholic acid) – Drug Safety Alert – February 1, 2018 – FDA is warning that the liver disease medicine Ocaliva® (obeticholic acid) has been incorrectly dosed daily instead of weekly in patients with moderate to severe primary biliary cholangitis (PBC), a rare chronic liver disease, increasing the risk of serious liver injury. Read more.

    Loperamide (Imodium®) Over-the-Counter (OTC) – Drug Safety Alert – January 30, 2018 – To foster safe use of the over-the counter (OTC) anti-diarrhea drug loperamide, the U.S. Food and Drug Administration (FDA) is working with manufacturers to use blister packs or other single dose packaging and to limit the number of doses in a package. Read more.

    Limbrel® (Medical Food), Primus Pharmaceuticals – Drug Recall Alert – January 26, 2018 – Primus Pharmaceuticals, Inc. of Scottsdale, Arizona is voluntarily recalling all unexpired lots of Limbrel products to the patient (user/consumer) level at FDA’s request. FDA has requested a recall of Limbrel due to rare but serious and reversible side effects associated with Limbrel. Read more.


    New First Time Generic

    No new updates.


    Clinical and Pharmacy News

    Drug Price Forecast Shows Biosimilars at a Tipping Point – February 1, 2018 – Biosimilars have reached a tipping point in the U.S. market, according to a new drug pricing forecast from consulting company Vizient. The forecast, which presents the Vizient pharmacy team’s best estimate of likely drug price behavior for the coming year, projects significant increases to the prices of originator biologics: antineoplastic agents, including bevacizumab and rituximab, are expected to see a class-wide price increase of 4.96 percent. Biologic disease-modifying anti-rheumatic drugs, such as etanercept, adalimumab and infliximab, are expected to rise by 11.95 percent. Read more.

    As States Target High Drug Prices, Pharma Targets State Lawmakers – February 1, 2018 – It was expected to be a perfunctory statehouse meeting — three lobbyists and a legislator discussing a proposal to educate Louisiana doctors about the price of drugs they prescribe. The bill seemed like a no-brainer in a country where even decades-old medicines can cost thousands and consumers are urged to make smart choices in buying healthcare. Read more.

    Specialty Pharmacies Could Play a Crucial Role Lowering 2018 Drug Costs – February 1, 2018 – Drug costs are a top priority for federal and state governments and are also a serious concern among Americans of all income levels. Many legislators and advocacy groups have called for reform to the supply chain in hopes that 2018 will be the year drug costs will be reined in. Read more.

    Statement from FDA Commissioner Scott Gottlieb, M.D., on Ongoing Efforts to Mitigate Impact of Saline Shortages During This Flu Season – February 1, 2018 – As flu activity remains widespread across the U.S., the FDA continues to monitor this situation closely and in coordination with our colleagues at the U.S. Centers for Disease Control and Prevention. We’re continuing to take steps to help ensure that people with the flu have access to critical medical products, including antivirals, saline and other supportive care drugs and devices. Read more.

    Prescription Drug Rate Growth Slows, But Prices Still Rising 7.35% – February 1, 2018 – Providers should anticipate a 7.35 percent increase in prescription drug rates between July 2018 and June 2019, researchers from Vizient projected in a new study. Based on hospital and non-acute facility purchasing data from the company’s Pharmacy Program, Vizient described the projected price increases as a “slightly moderated level of growth.” Last year, providers faced an estimated 7.61 percent increase in prescription drug rate. Read more.

    Study: Adhering to Clinical Guidelines Can Boost Hospital’s Bottom Line – January 31, 2018 – Improving care quality can help hospitals reduce readmissions and protect against financial penalties, a new report from AHA says. In evaluating the quality of care given to those hospitalized with heart failure, adherence to clinical guidelines may be a better measure of quality than the number of heart failure patients a hospital admits, according to new research in the American Heart Association’s journal Circulation. Read more.

    The Benefits of Integrating Pharmacists into Surgical Patient Education – January 31, 2018 – Patients that require surgery generally exhibit some degree of anxiety. There are numerous reasons for this anxiety, especially for someone who has never undergone such a surgical procedure previously. Pain, fear of the unknown and potential disability are all common sources of anxiety in this patient population. These fears can be difficult for healthcare professionals to fully ameliorate. Pharmacists are uniquely suited to addressing apprehension toward postoperative pain and associated medication regimens in patients that require surgery. Read more.

    Statement from FDA Commissioner Scott Gottlieb, M.D., On New Steps to Help Prevent New Addiction, Curb Abuse and Overdose Related to Opioid Products – January 30, 2018 – The issue of opioid misuse and abuse remains one of my highest priorities and we believe it’s going to take carefully developed, sustained and coordinated action by everyone involved to reduce the tide of opioid addiction and death afflicting our communities; while maintaining appropriate prescribing for patients in medical need. Read more.

    The Amazon Health-Care Threat Has Arrived – January 30, 2018 – The great and oft-heralded Inc. foray into healthcare is here, and it’s not what we expected. The company isn’t diving headlong into drug distribution or becoming a pharmacy benefit manager (PBM). Along with JPMorgan Chase & Co. and Berkshire Hathaway Inc., it announced a more interesting idea Tuesday – a new company aimed at lowering the cost of employee health coverage. Read more.

    Expanding Point-of-Care Responsibilities for Pharmacists Still a Consideration – January 29, 2018 – Practicing at the top of their license. I cannot count the number of times that I have heard executives and company representatives state this at meetings or in the news regarding what pharmacists ‘should’ be doing. I mean, it makes sense, expanding pharmacists capabilities is an issue we have been facing for over a decade now. Medication Therapy Management (MTM) hasn’t exactly taken off, and reimbursement isn’t that big. Read more.

    Study Says Treatment Guidelines, Not Patient Volume, May Be Most Important For Heart-Failure Care – January 29, 2018 – It’s long been conventional wisdom in the healthcare community that patient volume at a hospital correlates with the hospital’s quality of care. For example, annual volumes for both heart failure and heart attacks are important components of the quality index used by U.S. News & World Report to rate cardiology programs for its annual “Best Hospitals” rankings. Read more.

    Senators Back CMS Proposal to Increase Transparency Of Prescription Drug Costs – January 29, 2018 – A proposal from the Centers for Medicare and Medicaid Services (CMS) to increase the transparency and accuracy of prescription drug costs in Medicare Part D has earned the support of a bipartisan group of senators. Read more.

    More Stroke Patients May Receive Crucial Treatments Under New Guideline – January 24, 2018 – More patients could be eligible for critical treatments to remove or dissolve blood clots that cause strokes, according to a new treatment guideline issued by the American Heart Association/American Stroke Association. Read more.

    Community-Acquired Pneumonia – January 23, 2018 – Community-acquired pneumonia (CAP) is defined as pneumonia acquired outside hospital or healthcare facilities. Despite advances in antimicrobial therapy, CAP continues to be a significant cause of morbidity and mortality in adults. Influenza and pneumonia are the eighth-leading cause of mortality among adults in the United States and result in more than 60,000 deaths annually. Read more.

    Rite Aid Pulls In $1.3B With Latest Store Transfer to WBA – January 23, 2018 – Rite Aid Monday evening reported the successful transfer of 625 stores and related assets to Walgreens Boots Alliance, and has received cash proceeds of $1.3 billion, which it is using to repay all of its $970 million of outstanding secured loans while maintaining a strong liquidity position. Read more.

    Working Americans are Using Less Health Care, But Spending More – January 23, 2018 – Americans who get health insurance through their jobs are not using more medical care than they were five years ago, but they are spending more due to soaring medical prices, according to a new report. Read more.

    ACP Criticizes New Blood Pressure Guideline – January 22, 2018 – The American College of Physicians (ACP) came down hard on the new American College of Cardiology/American Heart Association blood pressure guideline that shifted the threshold and treatment target to 130/80 mm Hg. Read more.


    340B in the News

    340B Program: Important, but Weaknesses Cited – January 31, 2018 – Recent governmental actions endanger the controversial 340B Drug Pricing Program, even though a powerful congressional committee called the 340B program important, despite its flaws. Yet, none of the actions—from the introduction of new legislation to Medicare payment cuts—address the oversight and administrative weaknesses highlighted by the committee. Read more.

    340B Hospitals to Get Day in Court Over Drug Pricing Cuts – January 31, 2018 – The American Hospital Association, America’s Essential Hospitals and four other healthcare organizations have won their request for an expedited schedule for the court to hear their case over 340B drug pricing cuts. Read more.

    Hospitals Blast Report That Medicare 340B Cuts Will Help Beneficiaries – January 29, 2018 – Hospital groups are pushing back against a new analysis that predicts reimbursement cuts to 340B hospitals will benefit the industry overall and lead to lower costs for patients. The report, released Monday by the consulting firm Avalere, plays down the concerns of hospitals that led to the American Hospital Association lawsuit against HHS that seeks to overturn the estimated $1.6 billion in 340B cuts that went into effect Jan. 1. Read more.

    Why Medicare 340B Benefits Rural Hospitals the Most – January 29, 2018 – The findings contradict the notion that the new payment system will result in hospitals seeing a drastic cut in reimbursement. The majority of hospitals, 85 percent, will see net payment increases from recent Medicare Part B outpatient payment changes, with rural hospitals seeing much greater-than-average overall payment increases for 2018. The findings are included in new research from Avalere Health commissioned by the Community Oncology Alliance. Read more.

    Our Rural Hospitals and Clinics Are Under Attack – January 25, 2018 – Right now, policy developments in Washington, D.C., are placing our rural North Dakota hospitals and other healthcare providers at significant risk of shutting down, choking off healthcare access for thousands of patients in rural communities who have few other options. Read more.

    340B Program Fails to Meet Its Promise, Study Finds – January 25, 2018 – Underserved patients haven’t benefitted, researchers conclude. The 340B Drug Pricing Program, a 25-year-old discount plan aimed at boosting resources for hospitals treating low-income patients, has not delivered on its promise to enhance care for the needy, according to research from Harvard Medical School and the NYU School of Medicine. Read more.

    340B and the Medicare Cost Report – January 24, 2018 – Certain institutional providers are required to file a Medicare cost report annually to CMS, which uses that information to set prospective payment rates and determine if Medicare overpaid or underpaid a given institution during the submitted fiscal year. These reports are due to CMS five months after the institution’s fiscal year ends and include data such as facility characteristics, financial information, costs and charges. Read more.

    New Study Reinforces Call to Reform 340B Drug Pricing Program – January 24, 2018 – A study published in the New England Journal of Medicine on January 24, 2018 reinforces concerns that the 340B Drug Pricing Program is not functioning as intended and reform efforts are warranted. Read more.