浏览全部资源
扫码关注微信
1.成都中医药大学临床医学院感染科,成都 610075
2.海南中卫健康经济发展研究院,海口 570106
3.成都中医药大学基础医学院,成都 611130
Received:24 March 2024,
Revised:2024-11-12,
Accepted:18 November 2024,
Published:15 December 2024
移动端阅览
陈秋平,孙权,沈政男,等.舒格利单抗联合化疗方案一线治疗PD-L1高表达晚期食管鳞状细胞癌的成本-效用分析[J].中国药房,2024,35(23):2896-2902.
CHEN Qiuping,SUN Quan,SHEN Zhengnan,et al.Cost-utility analysis of sugemalimab combined with chemotherapy as first-line treatment for advanced esophageal squamous cell carcinoma with high PD-L1 expression[J].ZHONGGUO YAOFANG,2024,35(23):2896-2902.
陈秋平,孙权,沈政男,等.舒格利单抗联合化疗方案一线治疗PD-L1高表达晚期食管鳞状细胞癌的成本-效用分析[J].中国药房,2024,35(23):2896-2902. DOI: 10.6039/j.issn.1001-0408.2024.23.10.
CHEN Qiuping,SUN Quan,SHEN Zhengnan,et al.Cost-utility analysis of sugemalimab combined with chemotherapy as first-line treatment for advanced esophageal squamous cell carcinoma with high PD-L1 expression[J].ZHONGGUO YAOFANG,2024,35(23):2896-2902. DOI: 10.6039/j.issn.1001-0408.2024.23.10.
目的
2
从中国卫生体系角度出发,评估舒格利单抗联合化疗方案(以下简称“联合方案”)一线治疗程序性死亡受体配体1(PD-L1)高表达晚期食管鳞状细胞癌(ESCC)的经济性。
方法
2
根据GEMSTONE-304研究的数据构建分期生存模型,模型周期为3周,研究时限为10年,贴现率为5%。模型的主要输出参数包括总成本、质量调整生命年(QALY)、增量成本和增量成本-效果比(ICER)。采用成本-效用分析法评价联合方案相对于单用化疗方案的经济性,并通过单因素敏感性分析、概率敏感性分析和情境分析来评估基础分析结果的稳健性。
结果
2
联合方案相比于单用化疗方案的ICER为288 430.35元/QALY,远高于以1.94倍2023年中国人均国内生产总值(GDP)作为的意愿支付(WTP)阈值(173 354.52元/QALY)。舒格利单抗的成本是影响ICER的主要因素。当WTP阈值为1.94倍2023年中国人均GDP(173 354.52元/QALY)时,联合方案相比于单用化疗方案具有经济性的概率为0;当该药价格下降至6 107.41元/盒(600 mg)后,联合方案相比于单用化疗方案才会体现出经济性。
结论
2
从中国卫生体系角度出发,联合方案一线治疗PD-L1高表达晚期ESCC患者不具有经济性;当其价格降低50.65%,才具有经济性。
OBJECTIVE
2
To evaluate the cost-effectiveness of the first-line treatment using the combination therapy of sugemalimab and chemotherapy (hereinafter referred to as the “combination therapy”) for advanced esophageal squamous cell carcinoma (ESCC) with high programmed death-ligand 1 (PD-L1) expression from the perspective of the Chinese healthcare system.
METHODS
2
A partitioned survival model was constructed based on data from the GEMSTONE-304 study. The model cycle was set at 3 weeks, with a study duration of 10 years and a discount rate of 5%. The primary output parameters of the model included total costs, quality-adjusted life year (QALY), incremental costs, and incremental cost-effectiveness ratio (ICER). Cost-utility analysis was employed to assess the economic feasibility of the combination therapy compared to chemotherapy alone. The robustness of the base case analysis results was evaluated through univariate sensitivity analysis, probabilistic sensitivity analysis, and scenario analysis.
RESULTS
2
The ICER of the combination therapy compared to chemotherapy alone was 288 430.35 yuan/QALY, significantly exceeding the willingness-to-pay (WTP) threshold of 173 354.52 yuan/QALY which was set at 1.94 times the per capita gross domestic product (GDP) in 2023. The price of sugemalimab was the primary factor influencing the ICER. When the WTP threshold was set at 1.94 times the per capita GDP (173 354.52 yuan/QALY), the probability of the combination therapy being cost-effective compared to chemotherapy alone was 0. The combination therapy only became cost-effective compared to chemotherapy alone when the price of the drug dropped to 6 107.41 yuan per box (600 mg).
CONCLUSIONS
2
From the perspective of the Chinese healthcare system, the combination therapy for first-line treatment of advanced ESCC with high PD-L1 expression is not cost-effective; the combination therapy is cost-effective when the price of sugemalimab decreas by 50.65%.
ZHAN M , XU T , ZHENG H R , et al . Cost-effectiveness analysis of pembrolizumab in patients with advanced esophageal cancer based on the KEYNOTE-181 study [J ] . Front Public Health , 2022 , 10 : 790225 .
LIU Y , GE Q Q , XU S N , et al . Efficacy and safety of anlotinib plus programmed death-1 blockade versus anlotinib monotherapy as second or further-line treatment in advanced esophageal squamous cell carcinoma:a retrospective study [J ] . Front Oncol , 2022 , 12 : 942678 .
国家卫生健康委员会 . 中国卫生健康统计年鉴2023 [M ] . 北京 : 中国协和医科大学出版社 , 2023 : 117 .
National Health Commission . China health statistics yearbook 2023 [M ] . Beijing : China Union Medical College Press , 2023 : 117 .
XI Y Y , LIN Y , GUO W J , et al . Multi-omic characterization of genome-wide abnormal DNA methylation reveals diagnostic and prognostic markers for esophageal squamous-cell carcinoma [J ] . Signal Transduct Target Ther , 2022 , 7 ( 1 ): 53 .
CHEN J , DUAN Z G , LIU Y N , et al . Ginsenoside Rh4 suppresses metastasis of esophageal cancer and expression of c-myc via targeting the Wnt/β-catenin signaling pathway [J ] . Nutrients , 2022 , 14 ( 15 ): 3042 .
XI Y , SHEN Y X , WU D L , et al . CircBCAR3 accelerates esophageal cancer tumorigenesis and metastasis via spon- ging miR-27a-3p [J ] . Mol Cancer , 2022 , 21 ( 1 ): 145 .
WEI C , HU S X , LUO M J , et al . A novel mechanism of action of histone deacetylase inhibitor chidamide:enhan- cing the chemotaxis function of circulating PD-1(+) cells from patients with PTCL [J ] . Front Oncol , 2021 , 11 : 682436 .
KHAN Z , HAMMER C , CARROLL J , et al . Genetic variation associated with thyroid autoimmunity shapes the systemicimmune response to PD-1 checkpoint blockade [J ] . Nat Commun , 2021 , 12 ( 1 ): 3355 .
SALHAB M , MIGDADY Y , DONAHUE M , et al . Immunohistochemical expression and prognostic value of PD-L1 in extrapulmonary small cell carcinoma:a single institution experience [J ] . J Immunother Cancer , 2018 , 6 ( 1 ): 42 .
JIN Z X , WANG J P , SUN J J , et al . PD-1/PD-L1 based immunochemotherapy versus chemotherapy alone for advanced esophageal squamous cell carcinoma:a meta-analysis focus on PD-L1 expression level [J ] . Cancer Rep , 2023 , 6 ( 7 ): e1794 .
SHAH M A , KOJIMA T , HOCHHAUSER D , et al . Efficacy and safety of pembrolizumab for heavily pretreated patients with advanced,metastatic adenocarcinoma or squamous cell carcinoma of the esophagus:the phase 2 KEYNOTE-180 study [J ] . JAMA Oncol , 2019 , 5 ( 4 ): 546 - 550 .
LI J , CHEN Z D , BAI Y X , et al . First-line sugemalimab with chemotherapy for advanced esophageal squamous cell carcinoma:a randomized phase 3 study [J ] . Nat Med , 2024 , 30 ( 3 ): 740 - 748 .
XIE Q , WEN F , WEI Y Q , et al . Cost analysis of adjuvant therapy with XELOX or FOLFOX4 for colon cancer [J ] . Colorectal Dis , 2013 , 15 ( 8 ): 958 - 962 .
刘国恩 . 中国药物经济学评价指南2020 [M ] . 北京 : 中国市场出版社 , 2020 :4- 5 , 19 , 27 - 28 .
LIU G E . Guidelines for pharmacoeconomic evaluation in China 2020 [M ] . Beijing : China Market Press , 2020 :4- 5 , 19 , 27 - 28 .
XU L Z , CHEN M S , ANGELL B , et al . Establishing cost-effectiveness threshold in China:a community survey of willingness to pay for a healthy life year [J ] . BMJ Glob Health , 2024 , 9 ( 1 ): e013070 .
中国临床肿瘤学会指南工作委员会 . 中国临床肿瘤学会(CSCO)食管癌诊疗指南2023 [M ] . 北京 : 人民卫生出版社 , 2023 : 68 - 91 .
Guidelines Working Committee of the Chinese Society of Clinical Oncology . Chinese Society of Clinical Oncology (CSCO) esophageal cancer diagnosis and treatment guidebook 2023 [M ] . Beijing : People’s Health Publishing House , 2023 : 68 - 91 .
LATIMER N R . Survival analysis for economic evaluations alongside clinical trials:extrapolation with patient-level data:inconsistencies,limitations,and a practical guide [J ] . Med Decis Making , 2013 , 33 ( 6 ): 743 - 754 .
SHEN J , DU Y , SHAO R , et al . First-line sintilimab plus chemotherapy in locally advanced or metastatic esophageal squamous cell carcinoma:a cost-effectiveness analysis from China [J ] . Front Pharmacol , 2022 , 13 : 967182 .
U.S. Department of Health and Human Services National Institutes of Health National Cancer Institute . Common terminology criteria for adverse events version 6.0, CTCAE [EB/OL ] .( 2020-10-30 )[ 2024-11-12 ] . https://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm#ctc_60 https://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm#ctc_60 .
GIULIANI J , BONETTI A . Cost-effectiveness of newer regimens for the prophylaxis of chemotherapy-induced nausea and vomiting:review of the literature and real-world data [J ] . Curr Opin Oncol , 2020 , 32 ( 4 ): 269 - 273 .
陈秋平 , 邵明义 , 张容容 , 等 . 信迪利单抗联合化疗方案一线治疗晚期、复发或转移性食管鳞状细胞癌的成本-效用分析 [J ] . 中国药房 , 2023 , 34 ( 3 ): 345 - 349,360 .
CHEN Q P , SHAO M Y , ZHANG R R , et al . Cost-utility analysis of sintilimab combined with chemotherapy in first-line treatment of advanced,recurrent or metastatic esophageal squamous cell carcinoma [J ] . China Pharm , 2023 , 34 ( 3 ): 345 - 349,360 .
WILKE H , MURO K , VAN CUTSEM E , et al . Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW):a double-blind,randomised phase 3 trial [J ] . Lancet Oncol , 2014 , 15 ( 11 ): 1224 - 1235 .
YANG F , FU Y , KUMAR A , et al . Cost-effectiveness analysis of camrelizumab in the second-line treatment for advanced or metastatic esophageal squamous cell carcinoma in China [J ] . Ann Transl Med , 2021 , 9 ( 15 ): 1226 .
ZHOU C C , WANG Z P , SUN Y P , et al . Sugemalimab versus placebo,in combination with platinum-based chemotherapy,as first-line treatment of metastatic non-small-cell lung cancer (GEMSTONE-302):interim and final analyses of a double-blind,randomised,phase 3 clinical trial [J ] . Lancet Oncol , 2022 , 23 ( 2 ): 220 - 233 .
HUANG H Q , TAO R , HAO S G , et al . Sugemalimab monotherapy for patients with relapsed or refractory extranodal natural killer/T-cell lymphoma (GEMSTONE-201):results from a single-arm,multicenter,phase Ⅱ study [J ] . J Clin Oncol , 2023 , 41 ( 16 ): 3032 - 3041 .
胡善联 . 中国医保药品价格谈判回顾和展望 [J ] . 卫生经济研究 , 2024 , 41 ( 1 ): 9 - 13 .
HU S L . Review and prospects of medical insurance price negotiation in China [J ] . Health Econ Res , 2024 , 41 ( 1 ): 9 - 13 .
0
Views
168
下载量
0
CSCD
Publicity Resources
Related Articles
Related Author
Related Institution