伊鲁阿克治疗ALK阳性晚期NSCLC的药物经济学评价  

Pharmacoeconomic evaluation of iruplinalkib therapy for advanced ALK-positive non-small cell lung cancer

作　　者：汪虹 李浩楠 张慧 刘宇航[1,4] 许业友 翁开源 WANG Hong;LI Haonan;ZHANG Hui;LIU Yuhang;XU Yeyou;WENG Kaiyuan(School of Medical Business,Guangdong Pharmaceutical University,Guangdong 510006,China;School of Pharmaceutical Sciences,Peking University,Beijing 100191,China;International Research Center for Medicinal Administration,Peking University,Beijing 100191,China;Health Economics and Promotion Research Center,Guangdong Pharmaceutical University,Guangzhou 510006,China)

机构地区：[1]广东药科大学医药商学院,广州510006 [2]北京大学药学院,北京100191 [3]北京大学医药管理国际研究中心,北京100191 [4]广东药科大学卫生经济与健康促进研究中心,广州510006

出　　处：《中国药房》2025年第8期945-950,共6页China Pharmacy

基　　金：教育部人文社会科学研究一般项目(No.22YJAZH147);广东省哲学社会科学规划一般项目(No.GD24CGL29);广东省普通高校创新团队项目(No.2022WCXTD011);广州市哲学社会科学发展“十四五”规划2023年度一般课题(No.2023GZYB68);广东药科大学药物经济学与卫生技术评估研究团队项目(No.2024ZZ13)。

摘　　要：目的从我国卫生体系角度出发,评价伊鲁阿克用于ALK阳性且之前没有接受过ALK-酪氨酸激酶抑制剂(TKIs)治疗的非小细胞肺癌(NSCLC)患者的经济性。方法从中国卫生体系角度出发,基于INSPIRE研究,建立三状态的分区生存模型模拟疾病发展进程,设定模拟周期为3周,研究时限为15年,贴现率为5.0%,比较伊鲁阿克和克唑替尼两种方案治疗ALK阳性的晚期NSCLC的总成本、质量调整生命年(QALY)和增量成本-效果比(ICER);以1~3倍我国2023年人均国内生产总值(GDP)(89358~268074元)作为意愿支付(WTP)阈值比较两种方案的经济性,并采用情境分析(改变生存曲线分布、效用值)和敏感性分析来验证模型的稳定性。结果与克唑替尼方案相比,伊鲁阿克方案的ICER为194412.74元/QALY,小于3倍我国2023年人均GDP(268074元)的WTP阈值;改变生存曲线分布情境下的结果与基础分析结果一致,但提高疾病进展状态的效用值后,ICER大于WTP阈值,伊鲁阿克方案将不再具有经济性优势。单因素敏感性分析结果表明,伊鲁阿克的成本、疾病进展状态效用值等对ICER的影响较大。概率敏感性分析表明基础分析结果稳健。结论从我国卫生体系角度出发,与克唑替尼方案相比,伊鲁阿克治疗ALK阳性且之前没有接受过ALK-TKIs治疗的NSCLC具有经济性。OBJECTIVE To evaluate the cost-effectiveness of iruplinalkib for ALK-positive non-small cell lung cancer(NSCLC)patients who had not previously received ALK-tyrosine kinase inhibitors(TKIs)from the perspective of the Chinese healthcare system.METHODS Based on the INSPIRE clinical trial,a three-health state partitioned survival model was developed to simulate the progression of disease,with model cycle of 3 weeks and a life-year time range of 15 years;the discount rate was 5%.For the treatment of ALK-positive advanced NSCLC,total cost,quality-adjusted life year(QALY),and incremental costeffectiveness ratio(ICER)were compared between iruplinalkib and crizotinib;using 1-3 times China’s per capita gross domestic product(GDP)(89358-268074 yuan)in 2023 as the willingness-to-pay(WTP)threshold,the cost-effectiveness of two regimens were compared.The sensitivity analysis and scenario analysis(altering the distribution of survival curves,utility values)were conducted to assess model robustness.RESULTS Compared with the crizotinib regimen,the ICER for the iruplinalkib regimen was 194412.74 yuan/QALY,which was below the WTP threshold of three times China’s per capita GDP in 2023(268074 yuan).The results under the scenario of altering the survival curve distribution were consistent with the base case analysis.However,after increasing the utility value of the disease progression state,the ICER exceeded the WTP threshold,and iruplinalkib no longer had a cost-effective advantage.The results of the one-way sensitivity analysis indicated that the cost of iruplinalkib and the utility values of disease progression states had a significant impact on the ICER.The probabilistic sensitivity analysis confirmed the robustness of the base case analysis results.CONCLUSIONS From the perspective of China’s healthcare system,compared with crizotinib regimen,the therapy with iruplinalkib is cost-effective for ALK-positive NSCLC patients who have not previously received ALK-TKIs.

关 键 词：伊鲁阿克 非小细胞肺癌 成本-效用分析 分区生存模型 药物经济学 

分 类 号：R956[医药卫生—药学]