背景： EMPOWER-LUNG 3临床试验显示，与安慰剂加化疗（PCT）相比，西米替尺单抗（CCT）加化疗明显延长了晚期非小细胞肺癌（NSCLC）患者的总生存期（OS）和无进展生存期（PFS）。然而，这种新治疗选择的成本效益尚不明确。因此，我们从中国医疗保健系统的角度评估了CCT作为NSCLC晚期患者的一线治疗与PCT相比的成本效益。 方法：我们构建了一个马尔科夫模型，评估CCT作为NSCLC晚期患者的一线治疗的成本效益。转换概率从EMPOWER-LUNG 3试验的生存数据中提取。药物成本参考国家招标价格，其他模型输入参数来自EMPOWER-LUNG 3试验和已发表的文献。 结果参数主要包括质量调整生命年（QALYs）和增量成本效益比（ICERs）。进行了单向灵敏度分析和概率灵敏度分析以评估模型结果的稳健性。结果：与PCT相比，在CCT方案中，总成本增加了79,667美元，增加了0.31 QALYs，导致ICER值为253,148美元/QALY。敏感性分析显示，OS的风险比（HR）、西米替尺单抗（100mg）的成本以及PFS的HR都对模型结果有显著影响。在中国，以每QALY 38,201美元为意愿支付阈值时，CCT（与PCT相比）成本效益为0%。 方案分析显示，当西米替尺单抗价格降低到每100 mg不超过184.09美元时，与PCT相比，CCT方案作为NSCLC晚期患者的一线治疗可以考虑成本效益。 结论：在中国，CCT作为NSCLC晚期患者的一线治疗不具有成本效益。版权所有 © 2023 Lu，Huang，Cai，Lin，Chen，Chen和Hu。

Background: The EMPOWER-LUNG 3 clinical trial has shown that cemiplimab plus chemotherapy (CCT) significantly extended overall survival (OS) and progression-free survival (PFS) for patients with advanced non-small cell cancer (NSCLC) compared to placebo plus chemotherapy (PCT). However, the cost-effectiveness of this new treatment option remains unknown. Thus, we evaluated the cost-effectiveness of CCT versus (vs.) PCT as the first-line treatment for patients with advanced NSCLC from the perspective of the Chinese healthcare system. Methods: We constructed a Markov model to evaluate the cost-effectiveness of CCT as the first-line treatment for patients with advanced NSCLC. The transition probabilities were extracted from the survival data of the EMPOWER-LUNG 3 trial. The drugs' costs were referred from national tender prices, while other model input parameters were derived from the EMPOWER-LUNG 3 trial and published literature. The outcome parameters mainly included quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs). One-way sensitivity analysis and probabilistic sensitivity analysis were performed to evaluate the robustness of the model outcomes. Results: Compared to PCT, in the CCT regimen, an additional $79,667 was spent in terms of the total cost and with an additional 0.31 QALYs, resulting in an ICER value of $253,148/QALY. Sensitivity analysis indicated that the hazard ratio (HR) of OS, the cost of cemiplimab (100 mg), and the HR of PFS, all significantly impacted the model's results. The probability of CCT (vs. PCT) being cost-effective was 0% at a willingness-to-pay threshold of $38,201/QALYs in China. The scenario analysis showed that when the price of cemiplimab was reduced to less than $184.09/100 mg, the CCT regimen could be considered cost-effective as the first-line treatment for patients with advanced NSCLC compared to the PCT. Conclusion: In China, the CCT was not cost-effective as the first-line treatment for patients with advanced NSCLC.Copyright © 2023 Lu, Huang, Cai, Lin, Chen, Chen and Hu.