帕博利珠单抗单药与化疗二线治疗晚期或转移性食管癌的成本-效果分析  

Cost-effectiveness analysis of pembrolizumab versus chemotherapy in the second-line treatment for advanced or metastatic esophageal cancer

作　　者：胡梦雪 高红婷 宁智鹏 侯艳红[1] HU Meng-xue;GAO Hong-ting;NING Zhi-peng;HOU Yan-hong(School of International Pharmaceutical Business,China Pharmaceutical University,Jiangsu Nanjing 211198,China)

机构地区：[1]中国药科大学国际医药商学院,江苏南京211198

出　　处：《中国医院药学杂志》2022年第3期318-323,共6页Chinese Journal of Hospital Pharmacy

摘　　要：目的:从我国卫生服务体系角度出发,评价帕博利珠单抗单药与化疗二线治疗晚期或转移性食管癌的经济性,为临床用药及相关卫生决策提供参考。方法:建立无进展生存、疾病进展和死亡3种健康状态的分区生存模型,以3周为模型周期,模拟患者终身,利用KEYNOTE-181临床试验数据和已发表的文献数据计算增量成本-效果比(ICER),并对关键参数进行敏感性分析。结果:基线结果显示,帕博利珠单抗单药治疗相对于化疗的ICER值在PD-L1(综合阳性评分CPS≥10)、鳞癌(ESCC)以及总意向治疗(ITT)人群中分别为964132.67元/QALY,601225.31元/QALY,1960060.48元/QALY。单因素敏感性分析结果显示帕博利珠单抗价格、健康状态效用值等对ICER影响较大。概率敏感性分析结果表明模型稳健。结论:在我国3倍人均GDP支付意愿阈值下,帕博利珠单抗单药对比化疗用于晚期或转移性食管癌的二线治疗不具有成本-效果。OBJECTIVE To evaluate the cost-effectiveness of pembrolizumab versus chemotherapy in the second-line treatment for advanced or metastatic esophageal cancer from the perspective of health service system in China,and provide reference for clinical use and health decisions.METHODS A partitioned survival model was established,which had three health states:progression-free survival,progressive disease and death,and its cycle was 3 weeks to simulate the life of patient.The incremental cost-effectiveness ratio(ICER)was calculated by using KEYNOTE-181 clinical trial data and the published literature data,and the sensitivity analysis of key parameters was conducted.RESULTS The basic analysis showed that the ICER of pembrolizumab in the PD-L1 CPS≥10(comprehensive positive score),squamous cell carcinoma(ESCC)and total intentionto-treat(ITT)population respectively was 964132.67yuan/QALY,601225.31yuan/QALY and 1960060.48 yuan/QALY when compared with that of chemotherapy.The results of deterministic sensitivity analysis showed that the price of pembrolizumab and the utility value of health status had great impacts on the ICER.The probabilistic sensitivity analysis results showed that the model was robust.CONCLUSION Pembrolizumab is not cost-effective as the second-line treatment for advanced or metastatic esophageal cancer under the willingness-to-pay threshold of 3 times GDP per capita in China.

关 键 词：帕博利珠单抗 化疗 分区生存模型 食管癌 成本-效果分析 

分 类 号：R956[医药卫生—药学]