Presentation (CTI)

OBJECTIVES: To compare outcomes-based reimbursement (OBR) architectures for CAR-T and gene therapies across EU5 markets — specifically Italy's AIFA staged-installment model and Germany's insurer-level rebate mechanism — against the current US CMS Cell and Gene Therapy (CGT) Access Model, and to identify structural design elements transferable to US Medicaid outcomes-based agreements (OBAs).
METHODS: Comparative policy analysis of AIFA's three-installment payment framework, Germany's GWQ ServicePlus mortality-triggered rebate mechanism for Kymriah, and the CMS CGT Access Model's current OBA structure for Casgevy and Lyfgenia.
RESULTS: EU5 models incorporate explicit installment staging and mortality/response-linked rebate triggers over defined post-treatment windows. The current CMS CGT Access Model OBA structure lacks an equivalent mechanism to protect outcome-measurement continuity when a patient experiences a coverage disruption mid-treatment-window — a gap with material exposure given new Medicaid community engagement requirements taking effect January 2027.
CONCLUSIONS: EU5 staged-payment and rebate-trigger architectures offer an operationally tested template for strengthening CMS OBA design, specifically through measurement-window continuity protections.