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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FDA, Medicare And The Future Of Coverage With Evidence Development For Accelerated Approvals
Health policy experts discuss ways Medicare coverage policy may evolve in the coming years and how efforts to smooth the transition between accelerated drug approvals and Medicare reimbursement decisions could play out.
US FDA Wants To Help Sponsors Generate Evidence CMS Needs, But Won't Be An Intermediary
FDA-CMS communications are expected to evolve as both agencies look to improve their relationship.
Lecanemab And Medicare: Could Better FDA/CMS Communication Improve Coverage Chances?
Eisai/Biogen’s promising Phase III data fueling the companies’ hopes that Medicare will relax coverage restrictions for their Alzheimer’s treatment candidate. If the sponsors fail to change the NCD, lecanemab will need to rely on a registry for reimbursement after full approval.