Biden Administration Announces Plans to Expand Access to SCD Therapies

The Biden administration announced Tuesday that sickle cell disease (SCD) will be the first focus of the Centers for Medicare and Medicaid Services’ cell and gene therapy (CGT) access model, which aims to improve health outcomes and increase access to cell and gene therapies for some of the nation’s most vulnerable populations.

Throughout the next year, CMS will partner with participating states and manufacturers to build a framework that expands access to gene therapies to treat SCD. Under the model, CMS will negotiate an outcomes-based agreement with participating manufacturers, which will tie pricing for SCD treatments to  improvements in health outcomes among people receiving Medicaid. Negotiations will also include additional pricing rebates and a standardized access policy.

Participating states will then decide whether to enter into an agreement with manufacturers based on the negotiated terms and offer the agreed-upon standard access policy in exchange for rebates negotiated by CMS. As part of the CGT Access Model, CMS will negotiate financial and clinical outcome measures with drug manufacturers and then reconcile data, monitor results and evaluate outcomes.

The CGT access model will begin in January 2025. States may choose to begin participating at a time of their choosing between January 2025 and January 2026.

Additional information about the CGT access model is available online.