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.
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Accelerated Approvals Could Have Expiration Dates, Annual Reviews To Promote Confirmatory Trials, ICER Suggests
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.
‘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.
Lower Reimbursement For Accelerated Approval Drugs May Get Push From ICER
ICER President Steve Pearson expresses interest in setting drug costs for accelerated approval drugs low with price increases based on confirmatory evidence ahead of upcoming white paper from the group.