CMS has decided that it will cover an expensive and new therapy that uses a patient’s own genetically modified immune cells to treat cancer.
The therapy, known as Chimeric Antigen Receptor T-cell (CAR T-cell), is FDA-approved and can treat people with specific types of cancer, such as non-Hodgkin lymphoma and B-cell precursor acute lymphoblastic leukemia.
“As the first type of FDA-approved gene therapy, CAR T-cell therapies are an important scientific advancement in this promising new area of medicine and provide treatment options for some patients who had nowhere else to turn,” CMS Administrator Seema Verma said in a statement.
The announcement, which was made in a national coverage decision, comes after CMS labored over the decision to cover the therapy for some time. The cost of the therapy is upwards of $500,000, according to one study, but can reach nearly $1 million per patient, the Wall Street Journal reported.
Under Medicare, CMS will now cover CAR T-cell therapy to treat cancer when administered at healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies (REMs) and use for an FDA-approved indication and for certain off-label uses upon recommendation.
According to CMS, the treatment is a “significant change from current practices,” and the agency will continue to monitor responses to the therapy in the Medicare population.
“We know there are relatively limited data about the use of these life-saving therapies in the Medicare population,” Acting FDA Commissioner Ned Sharpless, MD, said in a statement. “Our robust postmarket surveillance programs will continue to monitor for potential risks, as we do for all licensed and approved medical products. We will also continue to carefully assess the benefits and risks when considering whether to approve new CAR T-cell products.”
High-quality data have been collected for 1,400 patients treated for cancer with the therapy. Use of the therapy has been limited in part due to the high cost and uncertainty from hospitals if they would receive payment for providing it, according to the WSJ.