The Centers for Medicare & Medicaid Services (CMS) has announced a new initiative aimed at expanding access to gene therapies for sickle cell disease through the Cell and Gene Therapy (CGT) Access Model. This model involves 33 states, along with the District of Columbia and Puerto Rico, representing about 84% of Medicaid beneficiaries with the condition.
"This agreement is a major win for American patients and for Medicaid to provide patients new access to groundbreaking therapies for sickle cell disease," said U.S. Health and Human Services Secretary Robert F. Kennedy, Jr. He credited Dr. Oz's leadership in making this model a reality.
The CGT Access Model marks the first instance where the federal government has negotiated outcomes-based agreements with manufacturers on behalf of state Medicaid agencies. States will receive discounts and rebates if therapies do not deliver expected benefits. "This model is a game changer," said CMS Administrator Dr. Mehmet Oz, emphasizing its potential to deliver lifesaving therapies while holding manufacturers accountable.
Sickle cell disease can lead to severe health complications, increasing emergency visits and healthcare costs. Abe Sutton, Director of the Innovation Center and CMS Deputy Director, highlighted that the model aims to improve patient outcomes while ensuring effective use of state funds.
Key features include CMS-negotiated contracts with input from various stakeholders, optional federal support up to $9.55 million per state, flexible start dates between January 2025 and January 2026, and potential expansion to other diseases.
Participation is voluntary for states and manufacturers who responded to CMS' Request for Applications. The initiative reflects CMS' commitment to enhancing access to innovative treatments while managing Medicaid resources efficiently.
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