Medicare Coverage For CAR-T Will Require Additional Patient Data Collection
Draft national coverage decision addresses current indications and hospital sites of care. CMS expects to “leverage” existing FDA post-market data collection requirements but seeks additional data on patient-reported outcomes in some cases.
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Alliance for Aging Research worries the studies could drag on as long as the nine years Biogen is allowed for collecting Phase IV clinical data on its Aduhelm.
Medicare Final CAR-T Policy Eases Coverage Requirements
Product developers and researchers applaud the changes, including dropping "coverage with evidence development" approach.
Medicare CAR-T Coverage Decision Appears Hung Up In Political Review, Former CMS Official Says
Proliferation of expensive accelerated approval products requires "a revision to the existing evidence and policy approach for payers," Sean Tunis tells the DIA annual meeting.