CER Daily Newsfeed

US MFN Policies Are Driving The Need For Better RWE

(4/2, Francesca Bruce, Pink Sheet) reports “...Early engagement with patients in designing longitudinal studies will produce meaningful results.” Subscription Required

Real-World Evidence: Advancing Regulatory Decision-Making for Medical Devices

(4/2, Daniel Caños, Ph.D., MPH and Michelle Tarver M.D., Ph.D., FDA Voices) comments “...The FDA is redoubling efforts to utilize RWE across a wider range of medical devices to support timely access to safe and effective technologies, foster innovation, and strengthen the foundation of regulatory decision-making. We also continue to work with the National Evaluation System for health Technology (NEST) to assess and identify high-quality RWE sources that can be used for regulatory purposes. This comprehensive approach will enable more robust and efficient use of RWE to characterize the performance of medical devices in real-world settings.” Full

RWD Helps Researchers Include More Patients In Lymphoma Research

(4/2, Clinical Leader) reports “Randomized Phase 3 trials remain the gold standard in lymphoma research, but researchers are finding they often don’t reach the patients they intend to treat. Now, the integration of real-world data (RWD) with traditional clinical trials is reshaping how new studies are designed to better study new therapies in patients that desperately need them...In this Q&A, Andrew Evens, DO, MBA, explores how outcomes research and collaboration across academic networks, registries, and industry partners are advancing more inclusive, data-informed approaches to lymphoma care and future trial design.” Full

AI-Powered Cohorting Is Quietly Reshaping How Real-World Evidence Gets Built

(4/2, Glynn Dennis, MedCity News) comments “...One of the most visible effects of workflow-based cohorting is speed. Definitions that previously required weeks of back-and-forth can now be explored in hours. Plain-language inputs can be refined iteratively, with patient counts returned at each step. For teams working in HEOR, RWE, or clinical development, this changes the economics of exploration. Instead of prioritizing a small number of ‘safe’ analyses, teams can test more hypotheses, examine edge cases, and explore rare subpopulations that would otherwise be impractical.” Full

Judge Voids HHS Policy Limiting Hospital Discount Drug Purchases

(4/1, Nyah Phengsitthy, Bloomberg Law) reports "A federal judge vacated a 2013 policy from the US Health Resources and Services Administration that prohibits hospitals from simultaneously buying medicines though a government drug discount program and a group purchasing organization. 'HRSA offers almost no reasoning in the 2013 Policy-and the little it does provide fails to explain why the agency reached the conclusion it did,' Judge Loren L. Alikhan for the US District Court for the District of Columbia said in an order filed Tuesday. The policy is arbitrary and capricious and must be vacated, Alikhan concluded." Sub. Req'd

‘Lifesaving’: ACOs Laud Federal Move to Address Suspect Billing

(4/2, Bridget Early, Modern Healthcare) reports “...CMS said the billing codes it is limiting are flagged for ‘significant, anomalous, and highly suspect’ activity, meaning the change in volume isn’t easily explained by policy changes or increased demand. This type of deviation from historical patterns often signifies fraudulent, wasteful or abusive spending...‘For a lot of our members, this fix is existential,’ said Mara McDermott, CEO of the value-based care trade group Accountable for Health. ‘This guidance is lifesaving for their businesses and makes a huge difference in the quality and comprehensiveness of care for their beneficiaries.’” Subscription Required

EMA Explains How To Assess Quality Of RWD Used In Regulatory Submissions

(4/2, Neena Brizmohun, Pink Sheet) reports “...The European Medicines Agency says its new guidance offers actionable and focused recommendations for assessing the data quality of real-world data, with the aim of enhancing the usefulness of real-world evidence for regulatory purposes.” Subscription Required

MHRA-NICE Pathway Aims to Speed Drug Access

(4/2, Dr Rob Hicks, Medscape) comments “...An improved Integrated Scientific Advice service will support the pathway by clarifying regulatory and evidence requirements earlier in development. It will offer a single-entry point, meeting, report, and single payment. Advice will be provided independently but aligned on areas of overlap, such as endpoints and patient populations, the MHRA and NICE said. This will give companies more predictable timelines, clearer evidence requirements, and help reduce delays, said Professor Jonathan Benger, NICE chief executive.” Full