Accelerated Approval Price Trends Show Sponsors Can ‘Lose But Not Win’ From Confirmatory Trials
Study drills down into the lack of economic incentives for conducting confirmatory studies to inform policies that could remedy to the situation.
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Medicare Part B And Accelerated Approvals: MedPAC Mulls Use Of CED Versus Payment Caps
Medicare advisory panel discusses ongoing issues around launch prices that were not addressed by the government price controls targeting older drugs enacted as part of the Inflation Reduction Act.
‘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.
Medicare Registry Plan For Alzheimer’s Drugs Pairs CMS Web Portal With Health System Efforts
Lack of detail on data elements that would be required through the portal has stakeholders wondering if the Centers for Medicare and Medicaid Services has really found a way to make the registry requirement less of a threat to access for Alzheimer’s drugs with traditional FDA approval.