Page 87 - 《中国药房》2022年10期

纳武利尤单抗二线治疗转移性肾透明细胞癌的成本-效果分析 Δ

曹潆丹 1，2＊ ，石丰豪 ，孟 蕊 ，陈平钰 ，费正洋 ，张雪珂 ，马爱霞 （1.中国药科大学国际医药商学院，
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南京 211198；2.中国药科大学药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）10-1233-07
DOI 10.6039/j.issn.1001-0408.2022.10.13
摘 要 目的 评价纳武利尤单抗对比依维莫司二线治疗转移性肾透明细胞癌的经济性。方法 从我国卫生体系角度出发，采用三
状态分区生存模型对两种方案进行成本-效果分析，临床参数来自更新后的CheckMate 025研究，成本和健康效用来自相关网站和
已发表的文献。模型循环周期为2周，研究时限为患者终生。采用敏感性分析验证研究结果的稳健性；并探讨两种方案在模型模
拟时间为80个月和有慈善赠药方案两种情境下的经济性。结果 基础分析结果显示，与依维莫司方案相比，纳武利尤单抗方案的
增量成本-效果比（ICER）值为586 982.60元/质量调整生命年（QALY），远高于3倍2020年我国人均国内生产总值（GDP）。单因素
敏感性分析结果显示，对经济性评价结果影响较大的3个参数依次为纳武利尤单抗单价、纳武利尤单抗组患者疾病进展状态的效
用值和依维莫司组患者疾病进展状态的效用值。概率敏感性分析结果验证了基础分析结果的稳健性。情境分析结果显示，当模
型模拟时间为 80 个月时，纳武利尤单抗方案的 ICER 值为 417 204.52 元/QALY；当考虑针对低收入人群的纳武利尤单抗慈善赠
药方案时，ICER值为124 988.58元/QALY。结论 在1～3倍2020年我国人均GDP的阈值下，相比于依维莫司方案，纳武利尤单抗
方案用于二线治疗转移性肾透明细胞癌不具有经济性；当考虑针对低收入人群的慈善赠药方案时，纳武利尤单抗方案可能是经
济的。
关键词 纳武利尤单抗；转移性肾透明细胞癌；依维莫司；分区生存模型；成本-效果分析
Cost-effectiveness analysis of nivolumab in the second-line treatment of metastatic clear cell renal cell
carcinoma
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CAO Yingdan ，SHI Fenghao ，MENG Rui ，CHEN Pingyu ，FEI Zhengyang ，ZHANG Xueke ，MA Aixia 1，2
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（1. School of International Pharmaceutical Business，China Pharmaceutical University，Nanjing 211198，China；
2. Evaluation and Research Center of Pharmacoeconomics，China Pharmaceutical University，Nanjing 211198，
China）
ABSTRACT OBJECTIVE To evaluate the economical efficiency of nivolumab versus everolimus in the second-line treatment of
metastatic clear cell renal cell carcinoma. METHODS From the perspective of China’s health system，cost-effectiveness analysis of
the two therapies was carried out by developing a three-state partitioned survival model. The clinical parameters were from the
updated CheckMate 025 study，and the cost and health utility were from relevant websites and published literatures. The model
adopted a 2-week cycle and a lifetime research time. The robustness of the results was verified by sensitivity analysis. The
economical efficiency of two therapy schemes were evaluated in the scenario of model simulation time of 80 months and charitable
drug donation scheme. RESULTS The results of basic analysis showed that compared with everolimus， the incremental
cost-effectiveness ratio（ICER）of nivolumab was 586 982.60 yuan/quality-adjusted life year（QALY），which was far higher than 3
times of China’s per capita gross domestic product（GDP）in 2020. The results of single-factor sensitivity analysis showed that the
3 parameters that had the greatest impact on the economic evaluation results were the cost of nivolumab，the utility value of
nivolumab group and everolimus group in progressive disease state. The results of probability sensitivity analysis verified the
robustness of the basic analysis results. Results of scenario analysis showed that in the first scenario analysis，in which model
simulation time lasted for 80 months，ICER of nivolumab was 417 204.52 yuan/QALY；in the second scenario analysis，in which
nivolumab charitable drug donation program for low-income people was considered，ICER of nivolumab was 124 988.58 yuan/QALY.
CONCLUSIONS Under the threshold of 1-3 times of China’s per capita GDP in 2020，compared with everolimus，it is not
economical to use nivolumab as the second-line treatment for metastatic clear cell renal cell carcinoma； nivolumab is economical
when considering its charitable drug donation program for low-income people.
KEYWORDS nivolumab；metastatic clear cell renal cell carcinoma；everolimus；partitioned survival model；cost-effectiveness
analysis

Δ 基金项目：江苏省博士后科研资助计划项目（No.2021K496C） 肾细胞癌（renal cell carcinoma，RCC）是泌尿系统常
＊硕士研究生。研究方向：药物经济学、卫生经济与政策。 [1]
见的恶性肿瘤之一，占肾脏恶性肿瘤的80％以上 ，占成
E-mail：caoyingdanrr@163.com
[2]
人恶性肿瘤的2％～3％ 。多数肾癌患者在确诊时为局
# 通信作者：教授，博士生导师，博士。研究方向：药物经济学、卫
生经济与政策。E-mail：ma86128@sina.com 限性肾癌，有20％～30％的肾癌患者在确诊时为转移性

中国药房 2022年第33卷第10期 China Pharmacy 2022 Vol. 33 No. 10 ·1233 ·