CMS proposes Coverage with Evidence Development for Chimeric Antigen Receptor (CAR) T-cell therapy

The Centers for Medicare & Medicaid Services (CMS) proposed to cover FDA-approved CAR T-cell therapy, which is a new form of cancer therapy that uses a patient’s own immune system to fight the disease, under “Coverage with Evidence Development” (CED). Currently, there is no national Medicare policy for covering CAR T-cell therapy, so local Medicare Administrative Contractors have discretion over whether to pay for it.

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. Evidence from the registries and studies would help CMS identify the types of patients that benefit from CAR T-cell therapy, informing a future decision by the agency regarding the types of cases in which Medicare would cover the treatment with no registry or trial requirement.

CMS proposes 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 is issuing its proposal in response to a formal request, and today’s 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. CMS has issued seven National Coverage Determinations for drugs and biologicals over the past seven years.

To read the proposed decision, visit the CMS website.