Page 79 - 《中国药房》2023年5期

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
Δ

1
1＊
2
1
文恩辉 ，高 川 ，董娟妮 ，龙丽辉 ，戎彪学 （1.西安医学院第一附属医院临床药学室，西安 710077；2.西安
2 #
医学院第一附属医院肿瘤科，西安 710077）
中图分类号 R956；R979.1 文献标志码 A 文章编号 1001-0408（2023）05-0581-06
DOI 10.6039/j.issn.1001-0408.2023.05.13

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 35 025.32 元，人均增量效果为 2.71 QALYs，ICER 为
12 892.31元/QALY，远低于以3倍2021年我国人均国内生产总值（GDP）即242 928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80 000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 8 331.00
元/QALY 和 12 981.00 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。
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

Cost-utility analysis of tislelizumab monotherapy for second-line treatment of advanced or metastatic
esophageal squamous cell carcinoma
1
WEN Enhui ，GAO Chuan ，DONG Juanni ，LONG Lihui ，RONG Biaoxue（1. Clinical Pharmaceutics Room， the
2
2
1
1
First Affiliated Hospital of Xi’an Medical University， Xi’an 710077， China；2. Dept. of Oncology， the First
Affiliated Hospital of Xi’an Medical University， Xi’an 710077， China）
ABSTRACT 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
35 025.32 yuan，and incremental utility per capita was 2.71 QALYs； ICER was 12 892.31 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） 242 928 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
Δ 基金项目 陕西省科技计划（面上）项目（No.2021JM-491）；西安 group had a great impact on the ICER value， but these
市科技计划项目（No.20YXYJ0001-8） parameters could not cause the reversal of the basic analysis
＊第一作者 主管药师，硕士。研究方向：肿瘤药学、药动学。 results. Probabilistic sensitivity analysis showed that WTP
E-mail：enhuiwen@163.com
# 通信作者 副主任医师，副教授，博士。研究方向：肿瘤学。 threshold was higher than 80 000 yuan/QALY，the probability
E-mail：rbx3666610@163.com of tislelizumab monotherapy possessed cost-effectiveness was

中国药房 2023年第34卷第5期 China Pharmacy 2023 Vol. 34 No. 5 · 581 ·