Private Payers Have ‘Significant’ Role In Ensuring Confirmatory Trials Get Done, FDA’s Califf Says
In an unusual appearance at AHIP annual conference on Medicare and Medicaid, the US FDA commissioner discusses accelerated approvals and argues that payers should be more than ‘passive recipients’ of research. Insurers should help develop the confirmatory data for drugs, Califf says.
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The Center for Medicare and Medicaid Innovation also will develop demonstrations focused on payment arrangements for cell and gene therapy in Medicaid and promoting generic drugs in Medicare Part D.
US Medicare Payment Advisory Commission likely to recommend that drugs granted Accelerated Approval be subject to some form of price cap when confirmatory clinical data is lacking. The idea has a lot of supporters, but even they seem a bit unclear about how it could actually work.
A Greater Power: US FDA May Become More Insistent On Timing Of Accelerated Approval Confirmatory Trials
Bolstered by new statutory authority and the Oncology Center of Excellence’s experience in pushing for early initiation of confirmatory trials, review divisions may take a tougher line with sponsors on the design and timing of studies to verify clinical benefit.