Coverage With Evidence Development and Expedited Approvals: Policy Proposals For FDA and CMS

Based on stakeholder consultations, former FDA and CMS head Mark McClellan and former CMS official Sean Tunis present a potential upside for biopharma in broader use of Medicare coverage with evidence development. Pfizer executives participate in workshop on coordinating expedited drug approval, CED policies.

Medicare’s coverage with evidence development tool could be linked with expanded forms of accelerated FDA drug approval to help ensure effective postmarket evidence collection, stakeholders suggest in recent comments to the Centers for Medicare and Medicaid Services.

The combination of CED with accelerated approvals could help address payer concerns about products, such as targeted therapies, entering the...

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