Medicare coverage for CAR-T drugs on the horizon

Medicare could soon cover CAR-T therapies under new proposals from the US’ Centers for Medicare & Medicaid Services (CMS), which aim to also gather real-world evidence to eventually inform expanded coverage.

Currently, local Medicare Administrative Contractors have discretion over whether to pay for CAR-T treatments.

The proposed National Coverage Determination would require Medicare to cover the therapy nationwide when it is offered in a CMS-approved registry or clinical study, in which patients are monitored for at least two years post-treatment.

Although this means that access would initially still be limited, evidence from the registries and studies would help CMS identify the types of patients that benefit from CAR T-cell therapy, informing future decisions about the types of cases in which Medicare would cover the treatment with no registry or trial requirement.

“CAR T-cell therapy was the first FDA-approved gene therapy, marking the beginning of an entirely new approach to treating serious and even life-threatening diseases,” said CMS administrator Seema Verma. “The proposed coverage decision would improve access to this therapy while deepening CMS’s understanding of how patients in Medicare respond to it, so the agency can ensure that it is paying for CAR T-cell therapy for cases in which the benefits outweigh the risks.”

CMS is proposing to leverage the FDA’s requirements for post-approval studies for CAR-T to the fullest extent possible in reviewing studies for CMS approval.

The agency issued its proposal in response to a formal request, and the decision was informed by a meeting of the MEDCAC (Medicare Evidence Development & Coverage Advisory Committee) on August 22nd, 2018.

The MEDCAC provides CMS with an external review of medical literature, technology assessments, public testimony, and other data and information on the benefits, harms, and appropriateness of therapies under review.

The agency is now seeking public comments on the proposals.

A final decision will be issued no later than 60 days after the conclusion of the 30-day public comment period.

Though CAR-T therapies have garnered huge excitement, access is still limited by several factors, including manufacturing difficulties and slow progress towards reimbursement agreements.