The US Centers for Medicare and Medicaid Services (CMS; MD, USA) have recently announced a proposal to cover the FDA-approved CAR-T therapy under the category of ‘Coverage with Evidence Development’.
“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,” she added
The suggested National Coverage Determination requires Medicare to cover the therapy at registered cancer centers or in clinical studies where patients are observed for at least 2 years after undergoing treatment. Evidence gained from such studies will assist in guiding future decisions regarding expanding the availability of treatment.
“The initial requirements for centers to be engaged in a registry could limit breadth of use until there is additional real-world experience,” commented Brian Abrahams, analyst for RBC Capital Markets financial company (NY, USA).
Until now there has been no official national policy for Medicare regarding covering the treatment and they have had discretion over whether to pay. They have previously said they would pay the standard mark-up rate for the therapy, though only on an outpatient basis. Due to the risk of serious side effects, patients are usually admitted -leaving a large portion of the hospitalization costs uncovered.
CAR-T drugs Yescarta and Kymriah range in cost between $373,000–475,000, depending on the disease being targeted.