CAR-T Label Update Could Address Medicare Coverage Challenges, FDA’s Gottlieb Suggests

Medicare’s current approach to inpatient CAR-T reimbursement in 2019 would lead to an $186,500 shortfall for providers per patient, stakeholders estimate.

DNA

Labeling changes for the chimeric antigen receptor T-cell therapies could facilitate more generous Medicare reimbursement in the near term by moving treatment to the outpatient setting, US FDA Commissioner Scott Gottlieb pointed out at a policy conference on cancer sponsored by the Washington Post Nov. 13.

Medicare’s initial inpatient reimbursement policy for Novartis AG’s Kymriah (tisagenlecleucel) and Gilead Sciences Inc./Kite Pharma Inc.’s Yescarta...

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