目的 基于中国卫生体系，评估奥希替尼联合化疗治疗表皮生长因子受体（EGFR）突变晚期非小细胞肺癌（NSCLC）患者的成本效果。方法 基于Ⅲ临床试验数据FLAURA2研究构建三状态分区生存模型，比较奥希替尼联合化疗较单用奥希替尼的成本效果。通过单因素和概率敏感性分析以及情境分析来评估模型的稳健性。采用2025年中国人均GDP的3倍作为意愿支付阈值（WTP）进行20年期的价值评估。模型的主要结局包括质量调整生命年（QALYs）、总成本、增量成本效果比（ICER）。结果 奥希替尼联合化疗较单用奥希替尼治疗多获得0.55 QALY，ICER为200 457.43元·QALY^-1。单因素敏感性分析显示无进展生存期（PFS）效用值对ICER影响很大；概率敏感性分析表明，在当前WTP阈值情况下，奥希替尼联合化疗方案具有经济性的概率为97.1%；情境分析结果显示，随着模拟时间的延长，ICER逐渐降低，而且降低的幅度越来越小，但是ICER始终小于WTP阈值（298 995元·QALY^-1）。结论 从中国卫生体系生角度出发，奥希替尼联合化疗方案较奥希替尼单药治疗用于EGFR突变晚期NSCLC患者治疗具有经济效益。

Objective To evaluate the cost-effectiveness of osimertinib plus chemotherapy for the treatment of patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC) from the perspective of the Chinese healthcare system. Methods Based on the data from the phase III clinical trial FLURA2, a three-state partitioned survival model was constructed to compare the cost-effectiveness of combining osimertinib with chemotherapy versus using osimertinib alone. The robustness of the model was evaluated through univariate and probabilistic sensitivity analyses, as well as scenario analyses. A value assessment over a 20-year period was conducted, using three times the per capita GDP of China in 2025 as the willingness-to-pay (WTP) threshold. The primary outcomes of the model included quality-adjusted life years (QALYs), total costs, and incremental cost-effectiveness ratio (ICER). Results Osimertinib plus chemotherapy yielded an additional 0.55 QALYs compared to osimertinib monotherapy, with an ICER of 200 457.43 yuan per QALY. One-way sensitivity analysis indicates that the utility value of progression-free survival (PFS) has a significant impact on the ICER; Probability sensitivity analyses indicated that given the current WTP threshold, the probability that the osimertinib plus chemotherapy regimen is cost-effective was 97.1%; Scenario analysis revealed that the ICER gradually decreased over extended simulation periods, albeit at diminishing rates, while consistently remaining below the WTP threshold (298 995 yuan per QALY). Conclusion From the perspective of China’s healthcare system, the combination of osimertinib and chemotherapy demonstrates cost-effectiveness compared to osimertinib monotherapy for treating patients with advanced EGFR-mutated NSCLC.

R974

国家自然科学基金项目（82003790）；安徽省高校协同创新项目（GXXT-2021-068）；安徽省高等学校科学研究项目重点项目（2023AH053326）