The Centers for Medicare & Medicaid Services is expanding its Cell and Gene Therapy Access Model to include treatments beyond sickle cell disease, the agency announced. The expansion follows positive initial results from the voluntary program, which allows CMS to negotiate outcomes-based agreements with manufacturers on behalf of state Medicaid programs.
An evaluation of the initial model found that the CMS-led approach reduced administrative burden for state Medicaid programs and gave them greater negotiating leverage by pooling beneficiaries across states, according to the agency. The agency said this approach offers advantages compared to individual state-by-state negotiations.
The agency said it will release a Request for Applications in coming months to invite manufacturers of other cell and gene therapies to apply. The applications would allow negotiations for outcomes-based agreements to begin either shortly after FDA approval of a therapy or for treatments already approved.