Medicare issues final decision covering certain CAR T-cell therapies

Medicare will cover nationally Chimeric Antigen Receptor T-cell therapies approved by the Food and Drug Administration to treat certain cancers, as well as off-label uses recommended by compendia approved by the Centers for Medicare & Medicaid Services, the agency announced yesterday. The therapies, which use a patient’s own genetically modified immune cells to fight cancer, must be administered at health care facilities enrolled in FDA’s risk evaluation and mitigation strategies. Currently, the FDA has approved CAR T-cell therapy for certain types of leukemia and non-Hodgkin lymphoma. The policy also continues coverage for routine costs in certain clinical trials that use CAR T-cell therapy.