CMS to Increase Reimbursement for New Sickle Cell Gene Therapies through Outcomes-Based Agreements

1. CMS announced an increase in reimbursement for new sickle cell gene therapies, focusing on the first approved treatments, Casgevy and Lyfgenia.
2. The Biden-Harris Administration launched the Cell and Gene Therapy (CGT) Access Model, with sickle cell disease (SCD) as the initial focus.
3. The CGT Access Model aims to improve health outcomes, increase access to cell and gene therapies, and lower healthcare costs for vulnerable populations.
4. CMS will negotiate outcomes-based agreements (OBAs) with drug manufacturers, which tie pricing to health outcomes for people with Medicaid.
5. OBAs will include additional pricing rebates and a standardized access policy.
6. Participating states will decide whether to enter into an agreement with manufacturers based on the negotiated terms.
7. The CGT Access Model will begin in January 2025, with states able to begin participation between January 2025 and January 2026.
8. CMS will offer optional funding to states that engage in activities to increase equitable access to cell and gene therapy comprehensive care for people with Medicaid with SCD.
9. The model will include coverage of a defined scope of fertility preservation services and supports for ancillary services, such as travel expenses, case management, and behavioral health services.
10. CMS anticipates addressing additional care delivery gaps and other hurdles for people receiving cell and gene therapy during the model's implementation.