Cell and Gene Therapy (CGT) Access Model

• Cell and gene therapies can transform the lives of people living with rare and severe diseases that are hard to treat, but gaining access to these potentially life-changing treatments is difficult because they can cost millions of dollars. • The CGT Access Model supports outcomes-based agreements between states and manufacturers that will provide treatments within a framework that lowers prices for states and ties payment to outcomes. • By increasing access to transformative therapies, this model aims to improve the poor health outcomes and low life expectancy associated with rare and severe diseases like sickle cell disease, as well as make it easier for states to pay for cell and gene therapies. • The model underscores CMS’ commitment to accelerating access to innovative therapies, improving patient health, and tying payment to outcomes. • Through a Cooperative Agreement award, Implementation Funding will be available to states to support required and optional model implementation activities. Additionally, Milestone Funding will be available to States that successfully complete research projects related to increasing equitable access to sickle cell disease (SCD) gene therapy and promoting multi-disciplinary, comprehensive care for beneficiaries with SCD who are considering or receiving SCD gene therapy. Up to $9.55 million in Cooperative Agreement award funding is anticipated to be available to each selected award recipient over the course of up to 10 years and 5 months (August 1, 2025 - December 31, 2035).