CAR-T Therapy In Medicare: National Coverage Policy Could Come In 2019
Medicare begins analysis process for CAR-T cancer therapies in response to a request from UnitedHealthcare for a national coverage policy.
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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.
Medicare Evidence Development and Coverage Advisory Committee votes that four existing tools are valid and could be “generalizable” to Medicare beneficiaries.
Novartis, Gilead/Kite and Celgene protest the US Centers for Medicare and Medicaid Services’ decision to launch a Medicare coverage analysis for CAR-T drugs because it might lead to coverage restrictions.