The Cell and Gene Therapy (CGT) Access Model was announced by the Centers for Medicare and Medicaid Services in January 2024. The stated aim of this model is to increase access to CGTs and outcomes-based agreements for state Medicaid programs, thereby helping to mitigate the inherent complexities and financial uncertainties associated with CGTs. Currently, the CGT Access Model is only applicable to gene therapies for sickle cell disease. However, the model may expand to other diseases and CGTs. This white paper:

• Outlines the historical challenges associated with CGTs for Medicaid programs
• Details the CGT Access Model process and timelines
• Provides an overview of sickle cell and the in-market gene therapies currently eligible under the CGT program
• Explores considerations for expansion of the CGT Access Model