RWE Submissions: FDA Drafts Guidance
(5/8, Zachary Brennan, Regulatory Focus) reports “With an eye toward better tracking the use of real-world data to generate real-world evidence, the [FDA] on Wednesday drafted guidance to help sponsors provide information to the agency on their use of RWD and RWE in a uniform format. The uniform format is meant to help the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research track certain types of submissions using RWE under an investigational new drug application, new drug application or biologics license application.” Full
ACOs Less Likely to Leave Medicare Program After 3rd Year
(5/8, Rebecca Pifer, Healthcare DIVE) reports “...Some 30% of all MSSP ACOs exited within the first five years of the program, mostly midcontract, the study found. Of that, 4% exited in their first year, 9.5% in their second year, 20.7% in their third year, 10.6% in their fourth year and 11.2% in their fifth...Researchers also found ACOs with ‘little fat to trim’ were more likely to exit. This includes high-performing organizations with low benchmarks and existing ACOs that improved and dropped their benchmarks.” Full
NIH Gives First Look at All of Us Precision Medicine Research Health Database
(5/8, Heather Landi, Fierce Healthcare) reports “...To date, more than 192,000 people have enrolled, including more than 143,000 participants who have completed all of the initial steps of the program. The NIH announced on Monday the beta release of its interactive data browser to provide a preview of the data that study participants are sharing for health research. NIH is making the online database available to enable participants, researchers and other members of the public to learn more about the All of Us participant community and explore summary data, NIH officials said.” Full
UK NICE To Pharma Firms: Up Your Game In Horizon Scanning
(5/7, Ian Schofield, Pink Sheet) reports “...A senior official at the UK's National Institute for Health and Care Excellence has called on the pharmaceutical industry to play a greater role in topic selection and horizon scanning so that NICE can meet its objective of producing timely health technology assessments of new medicines. Meindert Boysen, director of NICE's Centre for Health Technology, also said because of time and resource constraints the institute cannot immediately look at every single medicine that emerges from company pipelines, neither can it negotiate complex managed access deals for all new drugs.” Paid Subscription Required
ECRI Institute Launches Health Care Horizon Scanning System
(5/8, ECRI Institute Press Release) “...The Health Care Horizon Scanning System will help patients, clinicians, researchers, payers, and policy makers identify at an early stage new therapeutics and healthcare technologies that have the potential to be disruptive. Initially, the focus will be on interventions for patients with Alzheimer's disease and other dementias, cancer, cardiovascular conditions, mental and behavioral health conditions, and rare diseases. PCORI may choose to add additional clinical areas for horizon scanning in the future.” Full
Why Do Accountable Care Organizations Leave The Medicare Shared Savings Program?
William K. Bleser, et al.
May 2019, Health Affairs
Comparative Effectiveness and Safety of Low-Strength and High-Strength Direct Oral Anticoagulants Compared with Warfarin: A Sequential Cohort Study
Nicole L Pratt, et al.
May 5, 2019, BMJ Open
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