Accelerated Approvals Could Have Expiration Dates, Annual Reviews To Promote Confirmatory Trials, ICER Suggests
Executive Summary
Institute for Clinical and Economic Review tackles reform of US FDA’s accelerated approval program in white paper responding to payer concerns about managing high-cost drugs supported by limited efficacy data and patient frustrations over possible access restrictions.
You may also be interested in...
US FDA Doesn’t Need Conditional Approval Pathway, Cavazzoni Tells House Committee
CDER director says agency has many tools to expedite development and does not endorse adding a pathway similar to EU’s conditional approval. Neurodegenerative diseases hearing in Energy & Commerce Committee focuses more on ALS than Aduhelm.
ICER, Accelerated Approval And The Payer Voice At The US FDA
Third-party cost-effectiveness reviewer ICER has a number of ideas for how US FDA could operate Accelerated Approval differently. But the group’s white paper raises a more fundamental questions: whether and how FDA should consider payer perspectives in regulatory decisions.
‘Dangling’ Accelerated Approvals: US FDA Flags Concerns About ‘Marginal’ Response Rates
Failed confirmatory trials for PD-1/L-1 inhibitor indications raise questions about marginal response rates in single-arm trials used to support accelerated approval, Oncology Center of Excellence leaders say in NEJM article that explains why the agency is taking six of these indications to its Oncologic Drugs Advisory Committee.