Page 85 - 《中国药房》2022年16期

·药物经济学·

纳武利尤单抗联合伊匹木单抗一线治疗不可切除恶性胸膜间皮

瘤的经济性评价 Δ

1，2 #
杜 怿 1，2＊ ，蒋 蓉 ，申 建 ，邵 蓉 （1.中国药科大学药品监管科学研究院，南京 211198；2.国家药品监
1，2
1，2
督管理局药品监管创新与评价重点实验室，南京 211198）
中图分类号 R956 文献标志码 A 文章编号 1001-0408（2022）16-1995-06
DOI 10.6039/j.issn.1001-0408.2022.16.14

摘 要 目的 评价纳武利尤单抗联合伊匹木单抗一线治疗不可切除恶性胸膜间皮瘤（MPM）的经济性。方法 从我国医疗保健系
统角度出发，构建分区生存模型，采用成本-效用分析法比较纳武利尤单抗联合伊匹木单抗（双免疫治疗方案）对比化疗一线治疗
不可切除MPM的经济性。临床数据来自CheckMate 743研究，直接医疗成本包括药品费用、疾病管理费用和不良反应处理费用，
成本和效用均按照5％的贴现率进行贴现。意愿支付阈值为3倍我国2021年人均国内生产总值（GDP）[242 928元/质量调整生命
年（QALY）]。通过情境分析比较双免疫治疗组患者接受赠药时这2种方案的经济性；通过单因素敏感性分析和概率敏感性分析
评价研究结果的稳健性。结果 基础分析结果表明，双免疫治疗方案的总成本高于化疗方案，同时效果也优于化疗方案，增量成本-
效果比（ICER）为417 122.2元/QALY，高于意愿支付阈值，双免疫治疗方案相比于化疗方案不具有经济性。患者在接受赠药的情
况下，双免疫治疗方案的成本为327 454.5元，ICER为75 664.1元/QALY，低于意愿支付阈值，结果发生反转。单因素敏感性分析
显示，无进展生存和疾病进展状态的效用值以及纳武利尤单抗价格等对 ICER值影响较大；概率敏感性分析提示，基础分析结果
稳健性较好。结论 在3倍我国2021年人均GDP的支付意愿阈值下，相比于化疗方案，纳武利尤单抗联合伊匹木单抗一线治疗不
可切除的MPM不具有经济性。但若患者接受赠药，则双免疫治疗方案更具有经济性。
关键词 纳武利尤单抗；伊匹木单抗；分区生存模型；恶性胸膜间皮瘤；成本-效用分析

Economic evaluation of nivolumab combined with ipilimumab in the first-line treatment of unresectable
malignant pleural mesothelioma
1，2
1，2
DU Yi ，JIANG Rong ，SHEN Jian ，SHAO Rong （1. Institute of Regulatory Sciences，China Pharmaceutical
1，2
1，2
University，Nanjing 211198，China；2. NMPA Key Laboratory for Drug Regulatory Innovation and Evaluation，
Nanjing 211198，China）
ABSTRACT OBJECTIVE To evaluate the cost-effectiveness of nivolumab combined with ipilimumab in the first-line treatment
of unresectable malignant pleural mesothelioma （MPM）. METHODS From the perspective of healthcare system，a partitioned
survival model were developed，the cost-effectiveness of nivolumab combined with ipilimumab（dual-immunotherapy plan）versus
chemotherapy in the first-line treatment of unresectable MPM by cost-utility analysis. Clinical trial data were collected from
CheckMate 743 study. Direct medical cost included drug costs，disease management cost and cost of treatment of adverse reactions.
Costs and utilities were discounted at an annual rate of 5％. The willingness to pay threshold was 3 times of gross domestic product
（GDP）per capita in 2021 [242 928 yuan/QALY（quality-adjusted life year）]. Scenario analysis was used to analyze and compare
the two regimens under the scenario of complimentary drug for patients in dual-immunotherapy group. The robustness of the
findings was evaluated by one-way sensitivity analysis and probabilistic sensitivity analysis. RESULTS Baseline analysis results
showed that total cost of dual-immunotherapy regimen was higher than that of chemotherapy regimen，and the utility was also
better than that of chemotherapy plan；the incremental cost-effectiveness ratio （ICER） was 417 122.2 yuan/QALY，which was
higher than the willingness to pay threshold；the dual-immunotherapy regimen was not cost-effective compared to the chemotherapy
regimen. Under the scenario of complimentary drug，the cost of dual-immunotherapy was 327 454.5 yuan，ICER was 75 664.1
yuan/QALY，which was lower than the willingness to pay threshold and resulted in a reversal of the baseline analysis. One-way
sensitivity analysis showed that under the health states of
Δ 基金项目 国家社会科学基金重大项目（No.15ZDB167）
progression free survival and progressive disease，utility value
＊第一作者 硕士研究生。研究方向：医药政策与法规、药物经济
and the price of nivolumab had a greater impact on the ICER
学。E-mail：duyi_better@163.com
value. Probabilistic sensitivity analysis showed that the results
# 通信作者 教授，博士生导师，博士。研究方向：医药政策与法
规、药事管理、药品监管等。电话：025-86185287。E-mail：shaorong118@ of baseline analysis were robust. CONCLUSIONS At a
163.com willingness to pay threshold of 3 times of GDP per capita in

中国药房 2022年第33卷第16期 China Pharmacy 2022 Vol. 33 No. 16 ·1995 ·