Today, the Centers for Medicare & Medicaid Services (CMS) proposed coverage of U.S. Food and Drug Administration (FDA)–approved chimeric antigen receptor (CAR) T-cell therapy under its “coverage with evidence development” paradigm. Currently, there is no national Medicare policy for covering CAR T-cell therapy, so local Medicare Administrative Contractors have discretion over whether to cover 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 2 years posttreatment. 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.
“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, MD. “Today’s 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 proposes to leverage the FDA’s requirements for postapproval studies for CAR T-cell therapy 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 Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) on August 22, 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 7 National Coverage Determinations for drugs and biologicals over the past 7 years.
CMS is seeking public comments on the proposed National Coverage Determination. A final decision will be issued no later than 60 days after the conclusion of the 30-day public comment period.
To read the proposed decision, visit the CMS website.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.