The Centers for Medicare & Medicaid Services (CMS) issued a proposed decision memo, the Proposed Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers, on February 15, 2019. Under this new coverage, patients with certain types of cancers could receive CAR T-cell therapy (CAR-T) if administered at an accredited hospital and if the treatment has been approved by the Food and Drug Administration to treat the patient’s cancer. CMS would cover CAR-T therapy through coverage with evidence development (CED), meaning the treatment would be provided “in the context of approved clinical studies or with the collection of additional clinical data.” Currently, CMS does not cover CAR-T treatment.
CAR-T immunotherapy is a process through which an individual’s immune system is ‘trained’ to attack individual tumors. This therapy is achieved by harvesting immune cells (i.e., T-cells) from a patient through a blood draw, genetically modifying these T-cells to provide a protein called chimeric antigen receptors (CARs), and then infusing these CAR-expressing T-cells back into the patient. Expression of CAR on these cells allows them to recognize and kill cancer cells with a matching protein, or antigen. In October 2017, the Food and Drug Administration (FDA) approved a CAR-T therapy to treat adult patients with large B-cell lymphoma. The FDA approved the second CAR-T therapy in May 2018 to treat some types of non-Hodgkin lymphoma.
Like many other gene therapies, CAR-T has a high price tag; the CAR-T therapy to treat B-cell lymphoma runs at approximately $475,000 per infusion.