The new rule stipulates that coverage will be provided only at healthcare facilities that are enrolled in FDA risk evaluation and mitigation strategies.
Medicare will offer nationwide coverage for Chimeric Antigen Receptor T-cell therapy to fight certain cancers, the Centers for Medicare & Medicaid Services has announced.
Coverage for CAR T-cell therapy, which harnesses a patient's genetically-modified immune cells to fight disease, will be limited for use in treating Medicare patients with certain types of non-Hodgkin lymphoma and B-cell precursor acute lymphoblastic leukemia, CMS said.
By some estimates, CAR T-cell therapy can cost as much as $375,000 for a one-time treatment, depending upon the cancer type and treatment regimen. That estimate does not include hospital stays and other related expenses.
CMS Administrator Seema Verma said the final rule "provides consistent and predictable patient access nationwide."
"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,” Verma said.
The new rule stipulates that coverage will be provided only at healthcare facilities that are enrolled in the Food and Drug Administration risk evaluation and mitigation strategies for FDA-approved indications.
Medicare will also cover FDA-approved CAR T-cell therapies for CMS-approved off-label uses.
In the final rule, CMS dropped a requirement that hospitals collect data on patient outcomes under the CAR T therapies, which hospitals had complained was too burdensome. Instead, CMS said it will monitor medical data from the FDA's post-approval safety studies.
The FDA has required CAR T-cell therapy makers to conduct post-marketing observational studies involving patients treated with the therapies.
"We know there are relatively limited data about the use of these life-saving therapies in the Medicare population. Our robust post-market surveillance programs will continue to monitor for potential risks, as we do for all licensed and approved medical products," said Acting FDA Commissioner Ned Sharpless, MD.
"We will also continue to carefully assess the benefits and risks when considering whether to approve new CAR T-cell products," he said.
“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
John Commins is a content specialist and online news editor for HealthLeaders, a Simplify Compliance brand.
KEY TAKEAWAYS
CAR-T therapy can cost as much as $375,000 for a one-time treatment. That estimate does not include hospital stays and other related expenses.
In the final rule, CMS dropped a requirement that hospitals collect data on patient outcomes under the CAR-T therapies, which hospitals had complained was too burdensome.
Instead, CMS said it will monitor medical data from the FDA's post-approval safety studies.