Practice Transformation
Over the next decade, expect more than 4.5 million hospitalizations of older adults due to serious medication side effects, warns The Lown Institute. In response, it released Eliminating Medication Overload: A National Action Plan. A group of 22 experts, including patient advocates, physicians, nurses, pharmacists and researchers, developed the plan. It recommends five high-level action areas: implement prescription checkups; raise awareness among clinicians, policymakers and the public; improve information at the point of care; educate and train health professionals to reduce medication overload; and reduce pharmaceutical industry influence. (Lown Institute)
Walgreens opened the first of its in-store “health corners” last month. The 12 pilot sites—all in Tennessee—will be staffed by dedicated pharmacists who will counsel customers on their medications or digital devices. According to the Seattle Times, it will not only counsel patients and help them manage chronic disease—it will promote the sale of health-related devices. It’s part of a partnership with Microsoft, which manages Walgreens’ data storage; the retailer leverages Microsoft’s AI platform and retail solutions. Microsoft will help analyze data from the pilot to develop “the pharmacy of the future.” (Seattle Times; Becker’s Hospital Review)
Evidence & Innovation
Sponsors aren’t keeping up with mandatory clinical trial reporting, according to an investigation by Science. Among more than 4,700 trials that should have had results posted to ClinicalTrials.gov, sponsors violated the reporting law more than 55% of the time. One reason: Reporting is considered an administrative and perhaps legal burden, not a scientific imperative. But it may be a clinical one: Some of the missing or late results “offer potentially vital information for the most desperate patients,” Science reports. (Science; MedPage Today)
This may be a record year for approvals, according to OptumRx’s Drug Pipelines Insights Report. Among its predictions: The FDA will evaluate over 150 new drug applications; 64 drugs already have anticipated approval dates in 2020. The most common category will be oncology, with 44 therapies expected to be reviewed this year. Of those, 70% will be high-cost orphan drugs. Treatments for neurological conditions came in second. The pipeline includes therapies for common conditions such as Parkinson’s disease, as well as novel therapies or rare or ultra-rare conditions such as spinal muscular atrophy. (Becker’s Hospital Review; report)
Policy Solutions
It’s officially not a kickback. The Department of Health and Human Services will allow Novartis to pay for travel, housing, meal and other expenses for Medicare and Medicaid beneficiaries who must travel to receive its CAR-T therapy Kymriah. HHS issued the ruling at the special request of Novartis; without the exception, the program could violate the anti-kickback statue of the Social Security Act. (FiercePharma; HHS advisory opinion)
The FDA last month released six final guidance documents on gene therapy manufacturing and clinical development, as well as draft guidance on interpreting the sameness of gene therapy products under the orphan drug regulations. By 2025, the FDA expects it will be reviewing and approving between 10 and 20 cell and gene therapies each year. The guidance documents will give drugmakers insight into how the agency will respond, Biopharma Dive reports. (BioPharma Dive; FDA announcement)
