Biden Administration Announces First Gene Therapies Included in CGT Access Model
December 05, 2024
The Centers for Medicare and Medicaid Services (CMS)
announced agreements with the manufacturers of two FDA-approved gene therapies for sickle cell disease (SCD) to participate in the agency’s new Cell and Gene Therapy (CGT) Access Model. These agreements aim to expand access for Medicaid patients to lovotibeglogene autotemcel (Lyfgenia) by Bluebird Bio and exagamglogene autotemcel (Casgevy) by Vertex Pharmaceuticals.
Led by the Center for Medicare and Medicaid Innovation, the voluntary CGT Access Model allows states and U.S. territories in the Medicaid Drug Rebate Program to negotiate outcomes-based agreements with therapy manufacturers, linking payments to improvements in patient health outcomes. The initiative seeks to enhance care, provide budget predictability for Medicaid programs and reduce long-term health care costs.
CMS is now working with states and territories to help them decide whether to participate. State
applications are open until Feb. 25, and states can participate in the model between January 2025 and January 2026. Additional information about the CGT Access Model is available
online.
