In early August 2019, the Centers for Medicare and Medicaid Services (CMS) issued the decision to cover Chimeric Antigen Receptor (CAR) T-cell therapies for cancer patients, so long as the administering healthcare facility complies with the Food and Drug Association’s (FDA) risk evaluation and mitigation strategies and uses the treatment for health indications as previously approved by the FDA. CAR T-cell treatments not approved by the FDA are not covered by Medicare under this decision.
CAR T-cell therapy is an immunotherapy that uses a genetically modified version of a patient’s own T-cells to bind to and destroy cancer cells. T-cells, along with B-cells, are classified as a subcategory of white blood cells and are responsible for mounting immune responses against pathogens. Because of T-cell’s role in the immune system, specifically its release of cytokines, a larger than normal amount of T-cells within a patient has been associated with a systematic inflammatory disorder, an autoimmune condition where one’s own T-cells destroy their healthy cells; however, drugs exist that combat this side effect.
The FDA has approved only two drugs, Kymriah and Yescarta, that utilize this technology to treat relapsed acute lymphoblastic leukemia and relapsed B-cell lymphoma; however, numerous clinical trials are currently taking place and may result in the approval of more therapies.
The CMS initiated its studies into covering CAR T-cell Therapy at the request of UnitedHealthcare, considered input from the public, and based its decision on expert opinions from the Medicare Evidence Development & Coverage Advisory Committee and published literature. In issuing this decision, the CMS hopes to grant more access to new treatments for Medicare beneficiaries.