替雷利珠单抗单药二线治疗晚期或转移性食管鳞状细胞癌的成本-效用分析  

Cost-utility analysis of tislelizumab monotherapy for second-line treatment of advanced or metastatic esophageal squamous cell carcinoma

作　　者：文恩辉 高川 董娟妮[1] 龙丽辉[1] 戎彪学 WEN Enhui;GAO Chuan;DONG Juanni;LONG Lihui;RONG Biaoxue(Clinical Pharmaceutics Room,the First Affiliated Hospital of Xi’an Medical University,Xi’an 710077,China;Dept.of Oncology,the First Affiliated Hospital of Xi’an Medical University,Xi’an 710077,China)

机构地区：[1]西安医学院第一附属医院临床药学室,西安710077 [2]西安医学院第一附属医院肿瘤科,西安710077

出　　处：《中国药房》2023年第5期581-586,共6页China Pharmacy

基　　金：陕西省科技计划(面上)项目(No.2021JM-491);西安市科技计划项目(No.20YXYJ0001-8)。

摘　　要：目的评价替雷利珠单抗单药二线治疗晚期或转移性食管鳞状细胞癌(ESCC)的经济性,为临床合理用药提供参考。方法从我国卫生体系角度出发,基于RATIONALE-302研究数据构建三状态分区生存模型,模拟时限为10年,循环周期为1个月。采用成本-效用分析法,以质量调整生命年(QALY)作为效用指标并计算增量成本-效果比(ICER),比较替雷利珠单抗单药方案相对于化疗方案二线治疗晚期或转移性ESCC的经济性。采用敏感性分析和情境分析来验证基础分析结果的稳健性。结果基础分析结果显示,相对于化疗组,替雷利珠单抗组患者的人均增量成本为35025.32元,人均增量效果为2.71 QALYs,ICER为12892.31元/QALY,远低于以3倍2021年我国人均国内生产总值(GDP)即242928元作为的意愿支付(WTP)阈值。单因素敏感性分析结果显示,阿帕替尼成本、疾病进展状态效用值和化疗组不良反应处理成本等参数对ICER值的影响较大,但这些参数均不能导致基础分析结果翻转。概率敏感性分析结果显示,当WTP阈值大于80000元/QALY时,替雷利珠单抗单药方案具有经济性的概率为100%。情境分析结果显示,当模型模拟时限分别为5年和20年时,替雷利珠单抗单药方案的ICER值分别为8331.00元/QALY和12981.00元/QALY,均未超过以3倍2021年我国人均GDP作为的WTP阈值。结论当以3倍2021年我国人均GDP作为WTP阈值时,相较于化疗方案,替雷利珠单抗单药方案二线治疗晚期或转移性ESCC更具有经济性。OBJECTIVE To evaluate the cost-effectiveness of tislelizumab monotherapy in the second-line treatment of advanced or metastatic esophageal squamous cell carcinoma(ESCC),so as to provide reference for rational use of drug in clinic.METHODS A three-state partitioned survival model was constructed from the perspective of China’s health system,based on the data of RATIONALE-302 study,with simulation time limit of 10 years,cycle period of 1 month.The incremental cost-effectiveness ratio(ICER)was calculated with quality-adjusted life year(QALY)as utility index.The cost-effectiveness of tislelizumab monotherapy was compared with that of chemotherapy for second-line treatment of advanced or metastatic ESCC by cost-utility analysis.The stability of basic analysis results was validated through sensitivity analysis and scenario analysis.RESULTS The results of basic analysis showed that compared with chemotherapy group,incremental cost per capita of tislelizumab group was 35025.32 yuan,and incremental utility per capita was 2.71 QALYs;ICER was 12892.31 yuan/QALY,which was far lower than the willingness-to-pay(WTP)threshold of 3 times of China’s per capita gross domestic product(GDP)242928 yuan in 2021.The results of univariate sensitivity analysis showed that parameters such as the cost of apatinib,the utility value of disease progression status and the cost of adverse reactions in the chemotherapy group had a great impact on the ICER value,but these parameters could not cause the reversal of the basic analysis results.Probabilistic sensitivity analysis showed that WTP threshold was higher than 80000 yuan/QALY,the probability of tislelizumab monotherapy possessed cost-effectiveness was 100%.Results of scenario analysis showed that in which model simulation time lasted for 5 or 20 years,ICER of tislelizumab was 8331.00 yuan/QALY and 12981.00 yuan/QALY,which were less than 3 times of China’s per capita GDP in 2021 as WTP threshold.CONCLUSIONS When three times of China’s GDP per capita in 2021 is taken as the WTP thresh

关 键 词：替雷利珠单抗 食管鳞状细胞癌 化疗 分区生存模型 药物经济学 成本-效用分析 

分 类 号：R956[医药卫生—药学] R979.1