On January 30, the Centers for Medicare & Medicaid Services (CMS) announced that sickle cell disease will be the first focus of the Cell and Gene Therapy (CGT) Access Model. The CGT Access Model is targeted to people with Medicaid living with rare and severe diseases by increasing their access to potentially life-changing treatments. Sickle cell disease is an extremely painful condition that disproportionately impacts Black Americans and has had limited treatment options. Individuals with the disease have a shorter life expectancy and face many long-term health complications. Under the CGT Access Model, CMS will negotiate outcomes-based agreements with manufacturers on behalf of states, and states will decide whether to participate in the agreement. Additionally, CMS will support the implementation of financial and clinical outcome measures, reconciliation of data, and evaluation of results. CMS anticipates releasing a Request for Application RFA) to manufacturers in early spring 2024 and an RFA and Notice of Funding Opportunity (NOFO) to states in summer 2024.
A webinar on the CGT Access Model is scheduled for February 6 at 2:00 p.m. ET.
Click here to register.
Click here to access a fact sheet on the CGT Access Model.
Click here to access the CGT Model webpage.