Investigators at Yale University School of Medicine Discuss Findings in Gene Therapy (Evaluating the Design and Implementation Challenges of the Centers for Medicare & Medicaid Services’ Cell and Gene Therapy Access Model): Biotechnology – Gene Therapy

2026 SEP 29 (NewsRx) -- By a News Reporter-Staff News Editor at Gene Therapy Daily News -- Investigators publish new report on Biotechnology - Gene Therapy. According to news originating from New Haven, Connecticut, by NewsRx correspondents, research stated, “Cell and gene therapies (CGTs) offer potentially curative treatments for conditions like sickle cell disease but pose major affordability and access challenges for Medicaid mainly due to multimillion-dollar upfront prices. In response, the Centers for Medicare & Medicaid Services (CMS) introduced the CGT Access Model, a purchasing approach that leverages the Medicaid Drug Rebate Program to implement multistate, outcome-based agreements for CGTs.”

Our news journalists obtained a quote from the research from the Yale University School of Medicine, “Through the Model, CMS negotiates core terms with manufacturers, states adopt these terms through rebate agreements, and CMS coordinates data collection and evaluation. The initiative aims to expand access, improve clinical outcomes, and generate long-term cost savings by aligning payment with demonstrated therapeutic benefit. However, critical uncertainties remain, including outcome-based agreement design, access policy standards, moral hazard risks, fertility-related barriers, out-of-state care challenges, and challenges with data collection.”

According to the news editors, the research concluded: “Although imperfect, the CGT Access Model marks an important step toward integrating sustainable financing of high-cost, transformative therapies into public insurance programs.”

This research has been peer-reviewed.

For more information on this research see: Evaluating the Design and Implementation Challenges of the Centers for Medicare & Medicaid Services’ Cell and Gene Therapy Access Model. Journal of Managed Care & Specialty Pharmacy, 2026;32(8):896-902. Journal of Managed Care & Specialty Pharmacy can be contacted at: Acad Managed Care Pharmacy, 100 N Pitt St, 400, Alexandria, VA 22314-3134, USA.

The news correspondents report that additional information may be obtained from Joseph T. Kannarkat, Yale University School of Medicine, Dept. of Psychiatry, New Haven, CT 06510, United States. Additional authors for this research include Yuxuan Bo, Varun Thachil and Jacob T. Kannarkat.

The direct object identifier (DOI) for that additional information is: https://doi.org/10.18553/jmcp.2026.32.8.896. This DOI is a link to an online electronic document that is either free or for purchase, and can be your direct source for a journal article and its citation.

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