CELL GENE THERAPY FINANCING & REINSURANCE PAYING FOR CURES, FAIRLY: A FEDERAL REINSURANCE AND OUTCOMES-BASED ANNUITY MODEL FOR CELL AND GENE THERAPIES IN THE UNITED STATES
Objective: The purpose of this study is to assess the budgetary, access, and innovation-incentives of a federal Reinsurance and Outcomes-based Annuity (ROA) model for financing cell and gene therapies, and to provide a practical policy framework for both public and private payers in the U.S. Methods: To model shifting gene therapy scenarios, linked payer budget-impact and a cohort Markov model(s) has been developed. The baseline status quo was compared to several ROA configurations—where in each configuration the re-insurance attachment points, coinsurance rates and annuity schedules including outcomes-contingent rebates were varied. Distributional effects were assessed across payers and plan sizes while incorporating realistic member churn, incidence of disease, and therapy price ranges. Results: In base-case simulations, a federal stop-loss reinsurance layer and five-year portable outcomes-based annuities decreased plan-level per-member-per-month volatility by more than sixty percent. Modeled access increased by twenty to forty percentage points for Medicaid and small commercial plans. Nationwide financing requirements were moderate when averaged across the insured population, and manufacturer value was stable or positive when increased access to treatment was greater than fifteen percent. Conclusions: The recommended ROA framework can lower budget shocks and inequities in access to therapies while maintaining innovation incentives. It can be operationalized through a federal demonstration program, which can be accomplished through specific regulatory changes.
Cell And Gene Therapy; Health Economics; Reinsurance Model; Outcomes-Based Annuity; Financing Innovation.