FDA, CMS Working To Smooth ‘Baton Handoff’ From New Drug Approval To Reimbursement
FDA commissioner Robert Califf wants to develop a postapproval evidence generation system through ongoing collaboration with CMS. Public health experts say efforts by FDA and CMS to work more closely could result in greater clarity on trial designs early in development programs.
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Centers for Medicare and Medicaid Services Administrator Chiquita Brooks-LaSure responds to US Congressional concerns about the proposed Medicare coverage policy for Alzheimer’s drugs.
At his Senate confirmation hearing, Robert Califf said he wants to establish a system, built on electronic medical records, that can be used to more quickly confirm the benefits and risks of accelerated approval drugs.
3,189 Days: Aduhelm Phase IV Timeline Is Long Among Alzheimer’s Drugs And Other Accelerated Approvals
Pink Sheet and Trialtrove analyses show time given Biogen to complete confirmatory trial exceeds duration of most other late-stage trials of anti-amyloid compounds and is almost double the average time allocated for follow-up studies of novel accelerated approvals since 2016; runway could reflect expectations for a longer follow-up period or potential enrollment challenges.