The Centers for Medicare and Medicaid Services has announced it will pay for the expensive cancer treatment CAR T-cell therapy, but questions remain on how much of the total cost of care will be covered and how much of the expense will be borne by hospitals.
The therapy costs $375,000 or $475,000, depending on the type of cancer being treated. Hospital stays due to the adverse effects of treatment can add hundreds of thousands of dollars to the cost.
The decision on coverage is left to private regional contractors hired by the agency to administer claims. The contractors will grant reimbursement so long as certain criteria are satisfied.
Most commercial insurers are covering CAR-T therapies, according to Kaiser Health News, but they do so on an individual basis.
CAR T-CELL COVERAGE
The FDA-approved Chimeric Antigen Receptor T-cell, or CAR T-cell therapy, uses a patient's own genetically-modified immune cells to fight specific types of cancer.
Medicare is covering CAR T-cell therapies to treat some people with non-Hodgkin lymphoma and B-cell precursor acute lymphoblastic leukemia.
The current treatments are Kymriah, made by Novartis for certain types of lymphoma and childhood leukemia, and Yescarta, which is manufactured by Gilead Sciences for lymphoma.
WHY THIS MATTERS
CAR T-cell therapy has shown impressive results, especially because it is often used only after other forms of treatment have been exhausted.
"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," said CMS Administrator Seema Verma.
Over 80 percent of patients who received Yescarta in clinical trials experienced either a complete or partial response in the extent of the cancer. Over 80 percent of children and young adults treated with Kymriah in clinical trials had their cancer go into remission, according to the Cleveland Clinic.
High-quality data, including demographics, tumor characteristics, course of cancer treatment, cellular product manufacturing details, and adverse events and outcomes have been collected for 1,400 patients treated for cancer with CAR T-cell therapies to date, CMS said.
But so far, outcomes data is limited, the agency said.
"It is important to monitor responses to CAR T-cell therapies in the Medicare population, as outcomes data for these patients are relatively limited and the treatment represents a significant change from current practices," CMS said.
CMS is relying on information obtained from the FDA's required post-approval safety studies. The FDA required the manufacturers of CAR T-cell therapies to conduct post-marketing observational studies of patients.
THE LARGER TREND
The National Cancer Institute began supporting the Cellular Immunotherapy Data Resource developed by the Center for International Blood and Marrow Transplantation Research three years ago to allow long-term follow-up and scientific study of patients receiving CAR T-cell therapies.
WHAT ELSE YOU NEED TO KNOW
Medicare will 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 biologics.
The therapy must be provided in healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies for FDA-approved indications.
ON THE RECORD
"We remain committed to supporting the efficient development of safe and effective CAR T-cell therapies. We know there are relatively limited data about the use of these life-saving therapies in the Medicare population. 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," said Acting FDA Commissioner Ned Sharpless, MD.
"NCI looks forward to continuing to support the expansion of this registry to include more cancer patients in the Medicare program and others being treated with CAR T-cell therapies," said Douglas R. Lowy, MD., acting director of NCI, where the first successful cancer treatment with CAR T-cells was developed. "We've recently seen dramatic progress in the development of CAR T-cell therapies and other treatments that harness patients' own immune cells to treat their cancers, and we continue to learn more in clinical studies."
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