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
Kevzara® (sarilumab) – May 22, 2017 – Regeneron Pharmaceuticals, Inc. and Sanofi announced the U.S. Food and Drug Administration (FDA) approval of Kevzara® (sarilumab) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX). Kevzara® is a human monoclonal antibody that binds to the interleukin-6 receptor (IL-6R), and has been shown to inhibit IL-6R mediated signaling. IL-6 is a cytokine in the body that, in excess and over time, can contribute to the inflammation associated with RA. Read More.
New Indication Approval
Keytruda® (pembrolizumab) – May 23, 2017 – the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda®) for adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, have MSI-H or dMMR colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan. RxS Clinical Insight: This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated. Read More.
Actemra® (tocilizumab) – May 22, 2017 – The U.S. Food and Drug Administration expanded the approved use of subcutaneous Actemra® (tocilizumab) to treat adults with giant cell arteritis. This new indication provides the first FDA-approved therapy, specific to this type of vasculitis. Read More.
New Drug Shortages
- Galantamine Tablets (Discontinuation)
- Glyburide Metformin Tablets (Discontinuation)
- Glyburide Tablets (Discontinuation)
- Indomethacin Capsules (Discontinuation)
Clinical and Pharmacy News
Drug Approvals Bounce Back As R&D Labs Churn Out New Winners – May 25, 2017 – The number of new drugs approved for sale in the United States and Europe has bounced back this year, suggesting a marked slowdown in 2016 was an aberration rather than a sign of flagging research and development productivity. Read More.
Top Three Roadblocks to Medication Adherence and How to Avoid Them – May 25, 2017 – With the expansion of accountable care organizations, bundle payments and other value-based payment models, the economic impact of readmissions has intensified. Hospitals have made significant investments in a wide array of intervention programs to reduce avoidable readmissions, such as enhanced discharge planning, nurse navigators, post-discharge follow-up calls and health coaches. Read More.
Trump’s Quiet on Drug Pricing, But His FDA Isn’t – May 24, 2017 – Scott Gottlieb, the Trump administration’s FDA commissioner, generally gets a big thumbs-up from the pharmaceutical industry. But he may end up making some drugmakers unhappy. Read More.
Prescription Drug Prices Rose Nearly 10 Percent in 2016 – May 24, 2107 – The cost of prescription drugs increased by 8.77 percent last year, the fourth consecutive year drug prices have gone up, according to data from the Truveris National Drug Index. The company further stated the 2016 increase represents an average annual price increase of 9.98 percent over the last year three years. Read More.
Can Amazon Change the Pharmacy Landscape? May 23, 2017 – Industry experts are eyeing Amazon’s exploration of possible entry into the online pharmacy market. MSN reported that Amazon is hiring a business lead to determine how the company can break into the pharmacy market. Read More.
Study Finds 22 Percent Antibiotic Failure Rate in Pneumonia Treatment – May 23, 2017 – The new study presented at the 2017 American Thoracic Society International Conference has found that about 22.1 percent, approximately one in four adults, failed to respond to antibiotics for community-acquired pneumonia (CAP) treatment. Read More.
Amazon’s Next Big Thing Should Make Pharmacies Very Scared – May 22, 2017 – Patients may be able to get their prescriptions filled by Amazon someday, and if so, it could significantly disrupt the retail pharmacy industry. According to reports, Amazon has been considering a push into pharmacy for a while, and they’re finally getting serious about it. According to CNBC, Amazon’s creating an internal pharmacy benefit manager to serve its 128,000 employees, and it’s developing a strategy that could allow it to provide prescription drug fulfillment to its customers nationwide. Read More.
A Bipartisan Way to Lower Drug Prices – May 22, 2016 – White House Budget Director Mick Mulvaney has floated an idea to bring down drug prices that’s both promising and — if other Republicans can be persuaded to go along — bipartisan. At a recent health care forum, Mulvaney proposed that drugmakers be required to pay rebates to the government on drugs sold to Medicare beneficiaries, as they do with drugs sold to Medicaid patients. Read More.
Impact of Patient Satisfaction on Specialty Pharmacy – May 22, 2017 – Patient satisfaction surveys have been a common part of community pharmacy assessments for decades. The surveys have been, and continue to be, used by both chain and independent pharmacies, which aid their organizations in identifying strengths, weaknesses and opportunities for improvement. Read More.
Disease-Awareness Ads Lead to Overdiagnosis, Boost Rx Sales – May 22, 2017 – Ads that try to bring awareness of diseases boost prescription drug sales and overdiagnosis in the U.S., according to a new study. There is a fine line between direct-to-consumer drug ads, which the Food and Drug Administration regulates, and ads meant to create disease awareness that often skirt the purview of the FDA, per the article published Thursday in JAMA. Read More.
Drugs Approved with Limited Data Aren’t Always Well-Tested Later – May 19, 2017- New medicines that win U.S. marketing approval without conclusive evidence of their effectiveness aren’t always proven to work after they go on sale, a recent research review suggests. Read More.
Pharma Exec Says Industry Must Get Fair About Pricing New Drugs – May 19, 2017 – The head of Regeneron Pharmaceuticals is warning the controversy surrounding drug prices could cripple the country’s pharma industry if companies don’t start to lower prices on their own. Read More.
Too May Drugs Too Close to the End? May 19, 2017 – Older adults often receive drugs that can be of questionable benefit during their last months of life, according to a large study that looked at the end-of-life medications prescribed across an entire nation. Clinical guidelines that support health care providers when they face the decision to continue or discontinue medications near the end of life are sorely needed, the researchers said. Read More.
Could Your Next Prescription Come From Amazon? May 19, 2017 – Amazon may be exploring a move into the $465 billion-a-year U.S. pharmaceutical market. It’s a market ripe for disruption but also a difficult one to enter, say analysts. There have been some clues in recent Amazon moves. In November, the company launched a one-hour delivery service for non-prescription items from Bartell Drugs, a 127-year-old pharmacy chain based in Seattle, as part of its Prime Now offerings. Amazon frequently tests programs around Seattle where it can be hands-on with them. Read More.
Why Your Neighborhood Pharmacy Could Be the Next Victim of the Retail Ice Age – May 19, 2017 – It’s no secret that the “Retail Ice Age” – led by online giant Amazon.com Inc. — has changed the way that people shop. Amazon has been a growing pain in the neck for low-price retailers like Wal-Mart Stores Inc. for some time, but even high-end specialty stores like Ralph Lauren Corp. have struggled now that Amazon has crept into their sector. Read More.
340B in the News
Letters: The 340B Program Is Failing to Help Patients in Need – May 22, 2017 – As the president of the Medical Oncology Association of Southern California and a practicing oncologist for nearly two decades, I have seen firsthand the negative impact the rapidly escalating abuse of the 340B Drug Pricing Program has had on cancer patients, health care costs and society. This growth has occurred without a proportional improvement in services to the poor and underserved — the very patients the program was designed to help. Read More.
340B Hospitals Criticize Further Delay of Drug Pricing Regulation – May 19, 2017 – Hospitals in the federal 340B Drug Pricing Program reacted with dismay to the May 18 announcement that the Department of Health and Human Services would yet again delay the enforcement of a regulation that would prevent drug companies from overcharging hospitals in the program. Read More.
Penalty Rule for Drugmaker Overcharges Pushed Back Third Time – May 19, 2017 – Drugmakers are getting another delay in a final rule imposing penalties on them for overcharging safety-net hospitals and other providers. The Department of Health and Human Services is delaying the rule’s effective date until Oct. 1, the agency said in a notice published May 19 in the Federal Register. This follows an earlier postponement until May 22, and an even earlier postponement until March 21. Read More.