Medicare will cover CAR T-cell therapy for leukemia and lymphoma.
With this type of immunotherapy, T lymphocytes from a patient’s blood are genetically modified in a laboratory setting and then re-infused, bringing an increased capacity for recognizing and attacking cancer cells.
“With Medicare expecting to cover CAR T therapy, patients who would otherwise die within a matter of weeks or months could be offered the potential for a cure,” says James Baumgardner, PhD, senior research economist, at Bethesda, Maryland-based Precision Xtract, which consults with pharmaceutical and life sciences companies. “A recent study comparing CAR T with cancer innovations over the past two decades suggests that CAR T represents a real paradigm shift, extending life to a much greater degree than we have typically seen on the forefront of cancer treatment.”
According to CMS, Medicare will cover CAR T-cell therapies when they are provided in healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies (REMS) for FDA-approved indications (according to the FDA-approved label). Medicare will also cover FDA-approved CAR T-cell therapies for off-label uses that are recommended by CMS-approved compendia. A compendium is used in determining medically-accepted uses of drugs and biologicals.
“The problem has been low uptake, possibly because health plans, including Medicare, have been slow to establish a reimbursement policy, leaving hospital leaders uncertain about what they will be paid for providing an expensive therapy that may include time in the ICU,” says Baumgardner. “Coverage is one step in the right direction, but adequate reimbursement will also be crucial.”