Cell and Gene Therapy (CGT) Access Model

Objectives: The Cell and Gene Therapy (CGT) Access Model aims to improve the lives of people with Medicaid living with rare and severe diseases by increasing access to potentially transformative treatments. Cell and gene therapies have high upfront costs but have the potential to reduce health care spending over time by addressing the underlying causes of disease, reducing the severity of illness, and reducing health care utilization. Initially, the model will focus on access to gene therapy treatments for people living with sickle cell disease, a genetic blood disorder that disproportionately affects Black Americans. The Notice of Funding Opportunity (NOFO) announces the opportunity to apply for Cooperative Agreement funding to support states’ participation in the CGT Access Model. The CGT Access Model is a voluntary model for states and manufacturers that tests whether a CMS-led approach to developing and administering outcomes-based agreements (OBAs) for cell and gene therapies improves Medicaid beneficiaries’ access to innovative treatment, improves their health outcomes, and reduces health care costs and burdens to state Medicaid programs. Within this model, CMS will negotiate standard key terms of an OBA directly with manufacturers of gene therapies approved or licensed by the U.S. Food & Drug Administration (FDA) for the treatment of sickle cell disease. After the key terms have been disclosed, states: (1) may apply to participate in the model in response to the State Request for Applications (RFA); and (2) may apply for Cooperative Agreement funding in response to the NOFO. • Cooperative Agreement funding is intended to support state model implementation activities and to support states that take steps to improve equitable access to gene therapy and multi-disciplinary, comprehensive care in conjunction with the model test.