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恩沙替尼一线治疗间变性淋巴瘤激酶阳性晚期非小细胞肺癌的

药物经济学评价 Δ

孙 蕾 1，2＊ ，周大创 ，陈平钰 ，马爱霞 （1.中国药科大学国际医药商学院，南京 211198；2.中国药科大学药
1，2
1，2 #
1，2
物经济学评价研究中心，南京 211198）
中图分类号 R956 文献标志码 A 文章编号 1001-0408（2022）12-1479-06
DOI 10.6039/j.issn.1001-0408.2022.12.12
摘 要 目的 评价恩沙替尼一线治疗间变性淋巴瘤激酶（ALK）阳性晚期非小细胞肺癌（NSCLC）的经济性，为我国医保决策及临
床合理用药提供参考。方法 从我国卫生体系角度出发，基于国际多中心Ⅲ期临床试验（eXalt3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30 d。比较恩沙替尼相对于克唑替尼（标准治疗方案）一线治疗ALK阳性晚期NSCLC的经济
性，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），再通过不确定性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，相对于克唑替尼组，恩沙替尼组患者的人均增量成本为－343 370.36元，人均增量效用为0.76 QALYs，
ICER为－454 292.25元/QALY，远低于1倍2021年我国人均国内生产总值（GDP，即80 976元）这一意愿支付（WTP）阈值。单因素
敏感性分析结果显示，无进展生存状态效用值、疾病进展状态效用值、克唑替尼后续治疗成本等参数对ICER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，在以1倍2021年我国人均GDP作为WTP阈值的前提下，恩沙替尼组
方案具有经济性的概率为100％。情境分析结果显示，改变恩沙替尼组后续治疗方案所得的ICER为－217 671.43元/QALY，仍远低
于WTP阈值。结论 针对我国ALK阳性晚期NSCLC患者，相对于目前应用较多的标准一线治疗方案（克唑替尼），恩沙替尼更具
经济性且为绝对优势方案。
关键词 恩沙替尼；克唑替尼；间变性淋巴瘤激酶；晚期非小细胞肺癌；药物经济学
Pharmacoeconomic evaluation of ensatinib in the first-line treatment of anaplastic lymphoma
kinase-positive advanced non-small cell lung cancer
1，2
SUN Lei 1，2 ，ZHOU Dachuang 1，2 ，CHEN Pingyu 1，2 ，MA Aixia （1. School of International Pharmaceutical
Business，China Pharmaceutical University，Nanjing 211198，China；2. Pharmacoeconomics Evaluation and
Research Center，China Pharmaceutical University，Nanjing 211198，China）

ABSTRACT OBJECTIVE To evaluate the economical efficiency of ensatinib in the first-line treatment of anaplastic lymphoma
kinase（ALK）positive-advanced non-small cell lung cancer（NSCLC），so as to provide reference for China’s medical insurance
decision-making and rational drug use in clinic. METHODS A three-state partitioned survival model was constructed from the
perspective of China’s health system，based on the data of the international multi-center phase Ⅲ clinical trial（eXalt3 trail），with
simulation time limit of 10 years，cycle period of 30 days. The economical efficiency of ensatinib was compared with that of
crizotinib（standard treatment）in the first-line treatment of ALK positive-advanced NSCLC. The incremental cost-effectiveness ratio
（ICER） was calculated with quality-adjusted life years （QALYs） as utility index. The stability of basic analysis results was
validated through uncertainty analysis. RESULTS The basic analysis results showed that compared with crizotinib group，
incremental cost per capita of ensatinib group was －343 370.36 yuan，incremental utility per capita was 0.76 QALYs，ICER was
－454 292.25 yuan/QALY，which was far lower than the willingness-to-pay（WTP）threshold of 1 time of China’s per capita gross
domestic product（GDP，80 976 yuan）in 2021. The results of univariate sensitivity analysis showed that progression-free survival
（PFS）status utility，progression of disease（PD）status utility and subsequent treatment cost of crizotinib had a greater impact on
ICER，but these parameters could not cause the reversal of basic analysis results. Probabilistic sensitivity analysis showed that with
1 time of China’s per capita GDP in 2021 as the WTP threshold，the probability of ensatinib group’s treatment possessed
economical efficiency was 100％. In the situational analysis，ICER obtained by changing the ensatinib group’s follow-up treatment
regimen was －217 671.43 yuan/QALY，which was far below WTP threshold. CONCLUSIONS For Chinese patients with ALK
positive-advanced NSCLC，compared with commonly used the first-line treatment（crizotinib），ensartinib is economical and
absolutely dominant.
Δ 基金项目：江苏省博士后科研资助计划项目（No.2021K496C）
KEYWORDS ensartinib；crizotinib；anaplastic lymphoma
＊硕士研究生。研究方向：药物经济学、卫生经济与政策。
E-mail：sunlei_cpu@163.com kinase； advanced non-small cell lung cancer； pharmaco-
# 通信作者：教授，博士生导师。研究方向：药物经济学、卫生经 economics
济与政策。E-mail：ma86128@sina.com

中国药房 2022年第33卷第12期 China Pharmacy 2022 Vol. 33 No. 12 ·1479 ·