奥希替尼用于表皮生长因子受体突变阳性非小细胞肺癌辅助治疗的成本-效用分析

Cost-utility analysis of osimertinib for adjuvant treatment of epidermal grouth factor receptor mutation-positive non-small cell lung cancer

目的从中国医疗卫生体系角度出发,评价奥希替尼用于表皮生长因子(epidermal grouth factor receptor,EGFR)突变阳性非小细胞肺癌(non-small cell lung cancer,NSCLC)肿瘤切除术后辅助治疗的成本-效果。方法构建五状态Markov模型,模型循环周期为1个月,模拟时限为患者终身。患者基线特征、状态间转移概率、不良事件发生率及健康效用数据主要来源于ADAURA研究,同时以CancerLinQ数据库、FLAURA研究及其他既往文献数据作为补充。医疗成本数据来源于官方发布的药品/医疗服务项目价格文件、文献及临床专家调研。同时,开展情境、单因素敏感性和概率敏感性分析。结果基础分析结果显示,对于EGFR突变阳性NSCLC肿瘤切除术后辅助治疗的患者,奥希替尼相比安慰剂的增量成本为25395.25元,增量质量调整生命年(quality-adjusted life year,QALY)为3.25,增量成本-效果比(incremental cost-effectiveness ratio,ICER)为7812.45元/QALY,远低于1倍中国人均GDP(2020年为72447.00元),奥希替尼具有成本-效果。情境、单因素和概率敏感性分析显示,基础分析结果稳健。结论在1倍人均GDP的阈值下,奥希替尼相比安慰剂,用于中国EGFR突变阳性NSCLC患者肿瘤切除术后辅助治疗具有成本-效果。

Objective To evaluate the cost-effectiveness of osimertinib for adjuvant treatment of patients with epidermal grouth factor receptor(EGFR)mutation-positive non-small cell lung cancer(NSCLC)after tumor resection from the perspective of Chinese healthcare system.Methods A 5-state Markov model with 1-month cycle was constructed,and the lifetime horizon was used.Data on patient baseline characteristics,transition probabilities,incidence of adverse events and health utilities were mainly derived from ADAURA study,supplemented by CancerLinQ database,FLAURA study and published literatures.Medical costs were derived from Chinese government documents,literature,and clinical expert surveys.Scenario analysis,one-way sensitivity analysis and probabilistic sensitivity analysis were conducted simultaneously.Results Base-case analysis results showed that for patients with EGFR mutation-positive NSCLC after tumor resection,the incremental cost of osimertinib compared with placebo was 25395.25 yuan,the incremental quality adjusted life year(QALY)was 3.25,the incremental cost-effectiveness ratio(ICER)was 7812.45 yuan/QALY,which was much lower than 1 times Chinese per capita GDP(72447.00 yuan in 2020).Osimertinib has cost-effectiveness.Scenario analysis,one-way sensitivity analysis and probabilistic sensitivity analysis indicated that base-case analysis results were robust.Conclusion Under the threshold of 1-time Chinese per capita GDP,osimertinib was predicted to be the cost-effective treatment option compared with placebo for patients with EGFR mutation-positive NSCLC after tumor resection in China.