CMS Proposes Coverage for CAR T-Cell Therapies

The Centers for Medicare & Medicaid Services (CMS) proposed new reimbursement policies for chimeric antigen receptor (CAR) T-cell therapies at cancer centers that meet certain criteria, including a registry or clinical study to monitor patient progress. If these policies are finalized, they could continue to limit CAR T-cell therapy for patients at the largest regional cancer centers.

Both Gilead’s axicabtagene ciloleucel and Novartis’ tisagenlecleucel have prices of $373,000 for treatment of non-Hodgkin lymphoma. Tisagenlecleucel is also approved for treatment of pediatric acute lymphocytic leukemia at a price of $475,000.

“Today’s proposed coverage decision would improve access to this therapy while deepening CMS’ understanding of how patients in Medicare respond to it,” CMS Administrator Seema Verma said in a statement, according to Reuters.

Last year, CMS agreed to pay for CAR T-cell therapy on an outpatient basis; however, most treated patients are hospitalized due to cytokine release syndrome toxicity and a large portion of those costs is uncovered. Moffitt Cancer Center currently has around $10 million in unpaid CAR T-cell therapy claims. “We still do not have a clear pathway for Medicare payment,” Jack Kolosky, the institute’s COO, told Reuters.

The proposed policies are open for public comment, and the agency also said that it plans to release new hospital payment terms from Medicare later this year.

Source: Reuters, February 15, 2019.