Divergent Paths, Convergent Goals: Institutional Experiments in Cell and Gene Therapy Regulation and Payment Between...

With the continuous advancement of CGT technologies, therapeutic regimens worldwide are confronting dual challenges: accelerated regulation and innovation in payment models. The United States has established a regulatory framework characterized by early-stage acceleration and late-stage evidence supplementation based on the 21st Century Cures Act, matching a market-driven payment model supported by commercial insurance and Medicare pilots. China adheres to technology-first with strict risk control, experiencing three regulatory phases and forming a government-led payment model via prudent national medical insurance and local supplementary coverage. Both countries face common dilemmas of long-term evidence shortage, payment system adaptation, and regional accessibility inequality. This study objectively clarifies the institutional differences between the two countries and subjectively proposes targeted solutions including risk-adapted hierarchical regulation, cross-border collaborative payment sharing, and industrial synergy, aiming to provide a reference for global CGT universal access.