21st Century Cures Act Driving FDA Changes
(9/7, Jessica Kim Cohen, Modern Healthcare) reports “...‘Real-world evidence has a lot of promise for expediting drug development,’ said Lucy Vereshchagina, vice president of science and regulatory advocacy at the Pharmaceutical Research and Manufacturers of America...That includes applying information to support approvals of off-label uses for drugs, which she called ‘low-hanging fruit for the use of RWE.’” Paid Subscription Required
Cigna Aims to Expand Affordable Access to Gene Therapies
(9/6, Shelby Livingston, Modern Healthcare) reports “...A spokeswoman for pharmacy giant CVS Health...said CVS is exploring outcomes-based contracts and refining its formulary and utilization management strategies for high-cost therapies with available alternatives. Meanwhile, a spokeswoman for Anthem said in an email that managing the high cost of gene therapies while also ensuring patients have access would require ‘proven therapy management techniques along with innovations that change how we pay for therapies.’” Paid Subscription Required
New Technologies for Evidence-Based Care Are Boosting Patient Outcomes
(9/6, Mike Miliard, Healthcare IT News) reports “...‘Our platform takes real-world data – data collected outside of a clinical trial or controlled setting – to create real-world evidence at scale,’ said [Aetion CEO Carolyn Magill]. ‘Most of our clients are biopharma and they are licensing the platform to assess the safety, effectiveness and value of medication,’ she explained. ‘They're really trying to understand how to get a better sense of how their medications work for specific patient populations that aren't always represented in a clinical trial.’” Full
Dipeptidyl Peptidase 4 Inhibitors and Risk of Inflammatory Bowel Disease: Real-World Evidence in U.S. Adults
Tiansheng Wang, et al.
August 30, 2019, Diabetes Care
Subscription Model for Antibiotic Development
Rebecca E Glover, et al.
September 6, 2019, BMJ
Why Do Health Technology Assessment Drug Reimbursement Recommendations Differ Between Countries? A Parallel Convergent Mixed Methods Study
Nicod E, et al.
September 6, 2019, Health Economics, Policy, and Law
Reminder: PCORI Annual Meeting
September 18 - 20, 2019