中国药房2025，Vol.36Issue(17)：2141-2147,7.DOI:10.6039/j.issn.1001-0408.2025.17.10
度伐利尤单抗联合化疗方案一线治疗晚期胆道癌的药物经济学评价
Pharmacoeconomic evaluation of durvalumab combined with chemotherapy as first-line therapy for advanced biliary tract cancer
摘要
Abstract
OBJECTIVE To assess the cost-effectiveness of durvalumab combined with chemotherapy as a first-line treatment for advanced biliary tract cancer from the perspective of the Chinese healthcare system.METHODS Using data from the TOPAZ-1 clinical trial,a three-state Markov model comprising progression-free survival(PFS),progressive disease(PD)and death was developed,with a cycle length of 21 days and a 10-year time horizon.Patients in the observation group received durvalumab in combination with gemcitabine and cisplatin,whereas those in the control group received placebo plus the same chemotherapy regimen.The evaluation indexes were quality-adjusted life year(QALY)and the incremental cost-effectiveness ratio(ICER).The willingness-to-pay(WTP)threshold was set at three times the 2024 Chinese per capita gross domestic product(GDP)(287 247 yuan/QALY).The sensitivity analyses,along with scenario analyses,were performed.RESULTS In the base-case analysis,the ICER of observation group compared to control group was 1 166 344.46 yuan/QALY,far exceeding the WTP threshold,indicating that the regimen was not cost-effective.One-way sensitivity analysis identified the PD state utility,discount rate,cost of durvalumab,and PFS state utility as the main drivers of ICER variation.Probabilistic sensitivity analysis showed that,at the above WTP threshold,the probability of the acceeptance of this regimen was 0,further supporting the robustness of the base-case findings.In the scenario analysis,inclusion of a patient assistance program reduced the ICER to 235 885.16 yuan/QALY,below the above WTP threshold,suggesting cost-effectiveness under this assistance program.However,when applying a regional WTP threshold set at three times the per capita GDP(158 475 yuan/QALY)of Gansu Province(the province with the lowest GDP in China in 2024),the ICER remained above the threshold,indicating that the regimen was not cost-effective at the regional level.CONCLUSIONS At current pricing,durvalumab plus chemotherapy as a first-line treatment for advanced biliary tract cancer is not cost-effective in China.Although the introduction of a patient assistance program can substantially reduce the ICER and achieve cost-effectiveness at a WTP threshold set at three times the 2024 per capita GDP of China,due to limited affordability in low-income areas,the program remains not cost-effective.关键词
度伐利尤单抗/化疗/晚期胆道癌/一线治疗/马尔可夫模型/药物经济学/成本-效用分析Key words
durvalumab/chemotherapy/advanced biliary tract cancer/first-line treatment/Markov model/pharmacoeconomics/cost-utility analysis分类
医药卫生引用本文复制引用
霍丽曼,段杨洋,梁平,单彬,孙晓利,冯锐..度伐利尤单抗联合化疗方案一线治疗晚期胆道癌的药物经济学评价[J].中国药房,2025,36(17):2141-2147,7.基金项目
国家卫生健康委创新药物上市后临床研究科研专项(No.WKZX2024CX501218) （No.WKZX2024CX501218）
河北省卫生健康委医学科学研究课题(No.20241142) （No.20241142）
