CMS expands gene therapy affordability program beyond sickle cell disease

Source: This report is based on an official public release from Centers for Medicare & Medicaid Services. PULSE organizes and summarizes public government communications.

The Centers for Medicare & Medicaid Services announced it is broadening a program that helps states negotiate better prices for cell and gene therapies. The CMS Innovation Center said it will expand the Cell and Gene Therapy (CGT) Access Model beyond its initial focus on sickle cell disease and invite manufacturers of other therapies to apply.

The expansion follows positive results from an initial evaluation of the program. The voluntary model allows CMS to negotiate outcomes-based agreements with manufacturers on behalf of state Medicaid programs. According to the agency, early evaluation results showed that CMS-led negotiations reduced administrative burden and gave state Medicaid programs greater negotiating leverage by pooling beneficiaries across states.

CMS said it will release a Request for Applications in the coming months to allow manufacturers to apply for the expanded model. The agency said this will enable outcome-based agreements to begin shortly after FDA approval or licensure of a therapy, or for therapies already approved.

The agency characterized the expansion as part of broader efforts to address health care affordability and give patients access to critical treatments.