Policy & Advocacy

Biden-Harris Administration Announces New CGT Payment Model

Margarita Valdez Martínez - February 01, 2024

On Tuesday, January 30, the Biden-Harris Administration announced the cell and gene therapy (CGT) access model. This model will enable the Centers for Medicare and Medicaid Services (CMS) to negotiate outcomes-based agreements with manufacturers. The CGT model is expected to launch in January 2025, and enrollment for states and select territories will be on a rolling basis. This multi-year model will be voluntary for both states and manufacturers. 

On Tuesday, January 30, the Biden-Harris Administration announced the cell and gene therapy (CGT) access model. This model will enable the Centers for Medicare and Medicaid Services (CMS) to negotiate outcomes-based agreements with manufacturers. The CGT model is expected to launch in January 2025, and enrollment for states and select territories will be on a rolling basis. This multi-year model will be voluntary for both states and manufacturers. 

The Administration announced its initial intent to launch a CGT-focused model in February 2023. At that time, cancer and sickle cell disease (SCD) were identified as therapeutic areas of interest; Tuesday’s announcement confirmed that CGT treatments for SCD will be the focus of the model. In December 2023, the FDA approved two gene therapies to treat SCD in patients 12 or older: Casgevy (exagamglogene autotemcel, or exa-cel) and Lyfgenia (lovotibeglogene autotemcel, or lovo-cel). There are at least 100,000 people in the United States who are living with SCD, many of whom are Black. People with SCD live with significant acute and chronic pain, and they are also at higher risk for heart, lung, and kidney problems. Access to these therapies is critical, especially considering the previously limited treatment options.

 “ASGCT is committed to expanding patient access to these therapies,” Jeffrey Chamberlain, PhD, President of ASGCT said. “These treatments are safe and effective and have the potential to transform the lives of those who receive them.”

As outlined in ASGCT's recent Q4 Cell, Gene, & RNA Therapy Landscape Report, a strong pipeline of investigational products is on the horizon. There are currently over 3,900 therapies in development ranging from preclinical through pre-registration. Many of the therapies in development are for rare diseases and/or previously underserved populations. A successful model could ensure broader access to future CGT treatments.

“The current system is not built to accommodate one-time durable therapies, which treat the underlying cause of disease and often have high upfront costs,” David Barrett, JD, CEO of ASGCT said. “Some states have grappled with balancing the upfront costs with the estimated long-term savings. In fact, states are not always adhering to the requirements to provide coverage for CGT products to their medically accepted indication. This model could be the first step in ensuring patient access to these innovative therapies.,”

See ASGCT’s Research on Medicare-Provided Access to CGT in Molecular Therapy

CMS is hosting a webinar on the model on February 6 to provide an overview of the model’s goals and the application process. So far, CMS has indicated that states and select territories can begin submitting their non-binding letters of intent to participate in the model as early as April. In March, CMS will release a request for application, and manufacturers will have the option to participate. Negotiations with manufacturers on outcomes-based agreements are expected to begin in May and go through November, with an expected launch in January 2025. This model could expand access to innovative, life-saving therapies if implemented properly.

ASGCT staff will continue to monitor updates on the model and share updates with the Society’s membership.

Important Links on the new CGT Model

CMS Press Rrelease

CMS Fact Sheet

CGT Access Model Website

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