医保指导建立商保创新药目录,是完善我国多层次医疗保障体系、破解高值创新药支付难题的重要举措。本研究以嵌合抗原受体T淋巴细胞（CAR-T）疗法为例,结合商保创新药目录的准入流程,探索创新支付实现路径: 构建了按疗效价值付费与预算总额控制的双重调控模型,设计了挂钩“治疗启动—短期缓解—长期生存”的分期支付机制,结合预算阈值触发熔断与超支折让。模拟测算结果显示,相比传统的一次性支付模式,创新支付模式可有效降低基金年度支出、提升资金使用效率与患者可及性。基于此,建议完善“三除外”的院内可及与监测设计,构建与疗效挂钩的分段独立结算机制,优化真实世界数据核验体系,完善政府定标准、市场做经办的分层治理架构,以实现价值导向、风险共担、可持续的创新药支付长效机制。
Abstract
The guidance for establishing a commercial innovative drug catalog is a crucial step toward improving China's multi-tiered healthcare security system and addressing the payment challenges associated with high-cost innovative medicines. Taking CAR-T therapy as an example, this paper explores pathways for innovative payment models by integrating the access process of commercial insurance catalog for innovative drugs. The study develops a dual regulatory model combining value-based payment according to therapeutic outcomes with total budget control, designing a phased payment mechanism linked to "treatment initiation—short-term remission—long-term survival", supplemented by budget threshold-triggered stop-loss mechanisms and cost-sharing discounts for overspending. Simulation results show that compared to traditional one-time payment models, the innovative payment approach can effectively reduce annual fund expenditures, improve financial efficiency, and enhance patient access. Based on these findings, we recommend refining hospital accessibility and monitoring designs under the "three exclusions" framework, establishing a segmented independent settlement mechanism tied to treatment efficacy, optimizing real-world data verification systems, and enhancing a tiered governance structure where government sets standards and the market manages operations, thus building a sustainable, time-value-oriented, risk-sharing, and long-term payment mechanism for innovative drugs.
关键词
商保创新药目录 /
CAR-T疗法 /
创新支付 /
实践路径
Key words
commercial health insurance drug catalog /
CAR-T therapy /
innovative payment /
practical pathway
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基金
国家自然科学基金面上项目“时空—政策—经济三元耦合驱动下国谈抗肿瘤药物可及性跨尺度机制解析与分层干预策略研究”（72574147）; 上海市高水平机构建设运行计划软科学研究资助项目“上海市创新药械准入效果评估与影响力提升路径研究”（25692113900）
