Presentation (CTI)

OBJECTIVES: The Cell and Gene Therapy (CGT) Access Model is a voluntary CMS initiative launched in January 2025 to test whether centralized purchasing and coverage of high-cost cell and gene therapies can standardize Medicaid access. The model focuses on sickle cell disease therapies, exagamglogene autotemcel (Casgevy®) and lovotibeglogene autotemcel (Lyfgenia®). This study evaluates how the Medicaid plans not participating in the model cover these therapies and the extent of variation across states.
METHODS: We identified states that opted into the CGT Access Model. For states not participating, we searched state Medicaid websites for coverage policies for Casgevy and Lyfgenia. For available policies, we assessed patient access criteria, including patient subgroup restrictions or step therapy requirements exceeding FDA-approved indications. All included policies were current as of December 2025.
RESULTS: As of December 2025, 33 states and 2 territories had opted into the model. Among the 17 states not participating, 7 had coverage policies for one or both therapies, resulting in 13 policies. One state excluded the therapies from coverage, while another offered coverage without specifying access criteria. Nine policies imposed requirements exceeding the FDA-approved indication. All nine included patient subgroup restrictions with varying vaso-occlusive crisis (VOC) thresholds: six required at least two VOCs over two years, one required two VOCs over one year, and two required four VOCs over two years. Two policies imposed an age restriction, excluding patients older than 50 years and seven imposed step therapy requirements, requiring failure of hydroxyurea before gaining access. One plan prefers Casgevy over Lyfgenia.
CONCLUSIONS: Access to Casgevy and Lyfgenia varies across states not enrolled in the CGT Access Model. In the absence of centralized decision-making, coverage policies are inconsistent, resulting in differing access barriers for the same therapies. Greater standardization of access criteria may help reduce geographic disparities for patients with sickle cell disease.