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.
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As final decision looms, initial move to hold off on DRG but increase payment for CAR-T therapies shows CMS taking a slow and steady approach to paying for the products.
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.
Pink Sheet Podcast: Finally, A US FDA User Fee Deal, ‘Pandemic Is Over’ Take-Aways, Tpoxx Development Issues
Pink Sheet reporters and editor discuss the impact of the long wait for a user fee deal to be negotiated, how the FDA will interpret President Biden’s statement that the COVID-19 pandemic is over, and concerns with the clinical development of the monkeypox treatment Tpoxx.