CMS has announced US nationwide coverage for CAR-T cell therapies, and has dropped its proposal of continued evidence-gathering by healthcare facilities.
The Centers for Medicare and Medicaid Services (CMS) has announced that it will make the new CAR-T cell therapies, Novartis’ Kymriah and Gilead’s Yescarta, available on Medicare.
This replaces the current system whereby regional Medicare administrators decide whether to cover the treatment, which costs between $375,000 – $475,000 dependent upon whether it is treating advanced lymphoma or paediatric leukaemia.
Notably, this commitment is not being proposed upon a ‘coverage with evidence development’ basis, a decision which has been praised by stakeholders.
Instead the CMS will rely upon reports provided by Novartis and Gilead to the Food and Drug Administration (FDA) and National Cancer Institute (NCI).
The package covers a broad range of facility types, allowing treatments to be administrated at hospitals or healthcare facilities enrolled in certain FDA-mandated safety programmes. Furthermore, both FDA-approved use and CMS-approved off-label uses will be covered.
Further information can be found here