CAR-T is an innovative cancer treatment that is being tested on mesothelioma patients. The protocol involves the stricken patient’s T-cells — part of their immune system — being withdrawn, changed in the lab, and then infused back into the patient. Their genetically modified cells then attack a protein on the surface of their specific cancer’s cells, killing them. It has been already been approved by the FDA for several types of cancers, but the treatment is exceedingly expensive, costing between $375,000 and $475,000 for the single treatment required. Now the Centers for Medicare and Medicaid Services have announced that Medicare will cover the costs for two types of cancer for which the FDA has already approved the treatment, as well as for off-label uses recommended in CMS-approved compendiums. This may mean that mesothelioma patients can be included in the coverage.
Coverage by Medicare promises “consistent and predictable access”
The CAR-T treatment protocols have been the subject of much optimism in the mesothelioma community, as it offers hope for the cure that has previously been elusive for victims of the rare, asbestos-related disease. Still, even if the treatment is proven successful, the costs put it out of reach for many. The move by Medicare is being touted as ensuring that patients will have “consistent and predictable access” to a potentially lifesaving therapy.
Though CAR-T is being tested on malignant mesothelioma patients, it has already proven highly effective in the treatment of lymphoma and pediatric leukemia, and those are the two uses that the FDA has already approved. The original consideration of providing compensation for the innovative treatment was held up by a requirement that hospitals had to concurrently collect and report data over a long period. This “evidence development” would have added significant cost to hospital, and as a result the healthcare industry pushed back against the proposal, calling it burdensome.
Administration eases originally proposed requirements
Instead, the requirement for hospitals to follow patients was dropped, and the government will instead put the burden of following patients and reporting outcomes on the drug company manufacturers, who will provide the information via a registry supported by the National Cancer Institute. Additionally, Medicare has agreed to provide coverage for CAR-T when it is provided in facilities that have enrolled in specific safety programs. This opens the door to it being offered on an outpatient basis, thus dramatically reducing the potential costs.
Though CAR-T therapy for the treatment of mesothelioma is not currently FDA approved, there is hope that the treatment will be both effective an will be approved as part of Medicare’s new program. If you are a mesothelioma patient and you need information on covering the costs of your care, the Patient Advocates at Mesothelioma.net can help. Call us today at 1-800-692-8608.