Biden Administration says that manufacturers of sickle cell gene therapies agree to participate in access model in 2025. Model may expand to include other therapies.
announced on December 5th that the manufacturers of the sickle cell disease gene therapies, Lyfgenia and Casgevy, have entered into agreements with CMS to participate in the Cell and Gene Therapy Access Model. . Take, for example, the first two sickle cell disease gene therapies approved by the Food and Drug Administration, Vertex’s Casgevy and bluebird bio’s Lyfgenia . Both were granted marketing authorization in December 2023.
The condition affects millions of people worldwide. In the United States, approximately 100,000 individuals are living with the disease, which predominantly impacts people of sub-Saharan African descent. In the case of sickle cell disease treatments, outcomes based agreements are a promising avenue for patient access. Given that Medicaid is a dominant payer—50% to 60%—in the sickle cell disease area, establishing arrangements between manufacturers and state Medicaid agencies is critical., led by the Center for Medicare and Medicaid Innovation, aims to test outcomes-based agreements for cell and gene therapies.
CMS Medicaid Outcomes-Based Agreements Risk Sharing Pay For Performance Sickle Cell Disease Patient Access
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