Clinical Insights: August 18, 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

    Besponsa® (inotuzumab ozogamicin) – August 17, 2017 – The U.S. Food and Drug Administration approved Besponsa® (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). RxS Clinical Insight: Besponsa® (inotuzumab ozogamicin) is approved with Orphan drug designation. Read more.


    New Formulation Approval

    No new updates.


    New Indication Approval

    Lynparza® (olaparib) – August 17, 2017 – The U.S. Food and Drug Administration granted regular approval to olaparib tablets (Lynparza, AstraZeneca) for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. Read more.


    New Drug Shortage

    August 17, 2017

    August 16, 2017


    New Drug Recall and Safety Alerts

    No new updates.


    New First Time Generic

    No new updates.


    Clinical and Pharmacy News

    August Is National Immunization Awareness Month – August 17, 2017 – National Immunization Awareness Month (NIAM) is observed every August to bring attention to the importance of vaccinating people of all ages. Immunizations are one of the most valuable contributions the overall human health and safety in modern times. They prevent people from getting serious illnesses or complications from those illnesses that just under a century ago may have meant certain death or long-term morbidity. Read more.

    Report: Big Price Hikes on Old Drugs Costing Medicaid – August 17, 2017 – Pharmaceutical companies are raising the price of drugs so much that Medicaid spent as much as $3.2 billion extra in 2016 just to pay for those higher prices, a new report found. Medicaid is a state-federal health care program that serves the poor, the elderly and the disabled. Read more.

    U.S. House Democrats Launch Probe into MS Drug Pricing – August 17, 2017 – U.S. House Democrats said on Thursday they were launching an investigation into why prices for Multiple Sclerosis (MS) treatments have nearly quintupled since 2004, and they sent letters requesting information from seven drugmakers. Read more.

    Revised Treatment Guidelines for Pediatric Acute Onset Neuropsychiatric Syndrome – August 17, 2017 – A panel of leading clinicians and researchers from various general and specialty pediatric fields have developed treatment guidelines for managing children and adolescents with Pediatric Acute Onset Neuropsychiatric Syndrome (PANS) and Pan Disorder Associated with Streptococcal Infection (PANDAS). Read more.

    Remicade Is a Litmus Test for PBMs – August 17, 2017 – Biosimilars – the equivalent of generic drugs for complicated and expensive medicines made by living cells – are supposed to reduce prices and save the health care system billions of dollars by finally bringing competition to blockbuster drugs. But as Bloomberg News has chronicled, they’ve been slow to gain traction. Read more.

    Physicians Should Partner with Pharmacists to Battle Quality Metrics – August 16, 2017 – Asked to define a patient’s care team, physicians will likely name everyone from their in-practice staff to caregivers and family members. But for many of the reasons outlined in this issue’s cover story, pharmacists should be added to that circle of those working to improve the patient’s well-being. From identifying alternative prescriptions covered at a lower cost by a patient’s plan to serving as an educator on disease management, pharmacists can play a huge role in aiding patient care. Read more.

    AGA Releases Guideline on Therapeutic Drug Monitoring in IBD – August 16, 2017 – The AGA has issued new guideline recommendations on therapeutic drug monitoring in patients with inflammatory bowel disease treated with anti-TNF agents and thiopurines. Read more.

    Express Scripts to Limit Opioid Drugs for First-Time Users – August 16, 2017 – The nation’s largest pharmacy benefit manager will soon limit the number and strength of opioid drugs prescribed to first-time users as part of a wide-ranging effort to curb an epidemic affecting millions of Americans. But the new program from Express Scripts (ESRX) is drawing criticism from the American Medical Association, the largest association of physicians and medical students in the U.S., which believes treatment plans should be left to doctors and their patients. Read more.

    ASCO Updates Treatment Guidelines for Advanced NSCLC – August 15, 2017 – ASCO has updated its guidelines for first- and second-line treatment of patients with stage IV non–small cell lung cancer (NSCLC). The organization has created new recommendations regarding the use of immunotherapy, and updated advice on targeted therapies for patients with mutations in the EGFR, ALK, or ROS1 genes. Read more.

    Can Conservatism, Inc. Hold Pharma Accountable for the Opioid Crisis? – August 15, 2017 – Big Pharma shouldn’t be counting on corporate welfare from the Trump administration. The crisis of confidence in the pharmaceutical industry remains one of the least well-reported elements of contemporary politics. And despite numerous scandals surrounding mismanagement and price gouging by Pharma companies, the proverbial big Kahuna of the industry’s scandals is undoubtedly the developing Opioid crisis. Read more.

    Drug Companies are Growing Less Generous in Helping Patients Pay for Meds – August 15, 2017 – For 14 years, Encino resident Ed Wright received an expensive prescription medication for free through a drug-industry program intended to assist people with limited or fixed incomes. Now he’s rationing his doses after a change to the program that imposed a $1,100 deductible before he can get a refill. Read more.

    Drug Shortage: Unexpected Reward – August 15, 2017 – Serendipity and medicine is a wonderful thing. It was serendipity that allowed Fleming to discover penicillin in the 1940s, and serendipity that led Von Merring and Miinkowski to determine that diabetes was a disease of the pancreas. Serendipity and pharmacy practice is the topic of an article published in BMG Quality & Safety. Written by a team of pharmacists from the University of Texas Southwestern Medical Center in Dallas, Texas, it describes how a drug shortage led to the adoption of a high-value care practice. Read more.

    Pharmacies Could Do More to Help Improve Everyone’s Health – August 15, 2017 – Most people aren’t aware that high street pharmacies offer much more than dispensing and selling medicines. Many also provide a wide range of services designed to improve public health, like supporting people to stop smoking, providing emergency contraception and testing for sexually transmitted diseases. Some also offer the national NHS Health Check, which identifies people with high blood pressure diabetes and chronic kidney disease and gives them information about the risk of having a heart attack or stroke. Read more.

    Retailers and PBMs Laud Generic/Biosimilar Savings – August 15, 2017 – Two of the nation’s largest pharmacy retail chains, along with the largest PBM, Express Scripts, rely on generic drugs to control overall health care costs. CVS, Walgreens, and Express Scripts are also putting their support behind biosimilar drugs, but to a lesser extent, since there are still only a handful of approved biosimilars on the market. Read more.

    Biosimilars Come to Community Pharmacy – August 15, 2017 – The long-awaited wave of biosimilar biologic agents is finally moving into community pharmacy. PBMs and payers are encouraging patients to move from the familiar long-acting insulin Lantus (insulin glargine, Sanofi) to Basaglar (insulin glargine, Lilly), approved by the FDA in late 2016. Read more.

    Pharmacies Prepare for Back to School – August 14, 2017 – It’s back to school. Retail pharmacies need to get ready for the onslaught of pharmacy needs that crop up among their younger patients as they return to school. “Children, ‘tweens, and teens cannot be underestimated, and need to be treated with importance,” said Charles Tabouchirani, RPh, Owner and Supervising Pharmacist at Cherry’s Pharmacy, a children’s pharmacy located in Manhattan. “We as pharmacists have a job in advising the younger generation on how to take medications and how to stay away from toxic medications.” Read more.

    Study: Patients More Likely to Get the Flu Shot When It’s Available at Retail – August 14, 2017 – Making influenza immunizations available through retail pharmacy increases the odds that a patient will get the flu shot, according to an article published in Clinical Therapeutics last week. The research cited by Clinical Therapeutics was conducted by Avalere and the National Association of Chain Drug Stores. Read more.

    New Site Spotlights PBM Fees that Raise Medicare Costs on Seniors Seeking Lifesaving Medications – August 14, 2017 – The National Association of Specialty Pharmacy (NASP) launched, a new website that spotlights the increasingly negative consequences of Direct and Indirect Remuneration (DIR) fees. Read more.


    340B in the News

    HHS’s Drugmaker Overcharge Penalty Rule Delayed Again – August 17, 2017 – Drugmakers are set to get more relief from a final rule imposing penalties on them for overcharging safety-net hospitals and other providers. The Department of Health and Human Services is proposing to delay the rule’s effective date until July 1, 2018, the agency said in a notice to be published Aug. 21 in the Federal Register. Read more.

    HHS to Delay 340B Final Rule until July 2018 – August 17, 2017 – The Department of Health and Human Services has again delayed the 340B final rule, which would penalize pharmaceutical companies that knowingly overcharge hospitals for drugs purchased through the program. This time the government is delaying it until July 2018. Read more.

    340B Covered Entities Beware: CMS Proposes Drastic Drug Reimbursement Rate Cuts – August 16, 2017 – In its Outpatient Prospective Payment System proposed rule (“Proposed Rule”), CMS outlined a significant Medicare Part B payment reduction for separately payable, nonpassthrough drugs provided in the hospital outpatient settings. You can find the Proposed Rule here. The proposal comes at a time when 340B stakeholders continue to face pressure to increase audit and program integrity efforts. Read more.

    Rural Hospitals Threatened by Big Pharma Effort – August 15, 2017 – Unless you work in health care, you are probably unaware of the 340B program. But the population served by your rural or inner-city hospital depends on it. More than 25 years ago, a deal was made between the pharmaceutical drug companies and the federal government. Read more.