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斯鲁利单抗联合化疗一线治疗晚期食管鳞状细胞癌的成本-效果分析
Cost-effectiveness analysis of serplulimab combined with chemotherapy as first-line treatment for advanced esophageal squamous cell carcinoma
- 中国药房 2023年34卷第14期 页码：1724-1729
- 作者机构：
中国药科大学国际医药商学院，南京 211198
- 作者简介：
硕士研究生。研究方向：卫生政策研究、药物经济学。E-mail：3220040576@stu.cpu.edu.cn
教授，博士生导师。研究方向：药品价格与采购政策、卫生技术评估。E-mail：cpucf@163.com
- 基金信息：
DOI：10.6039/j.issn.1001-0408.2023.14.12
中图分类号： R956纸质出版日期：2023-07-30，
收稿日期：2023-02-20，
修回日期：2023-06-17，
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严小雨,路云,常峰.斯鲁利单抗联合化疗一线治疗晚期食管鳞状细胞癌的成本-效果分析 Δ[J].中国药房,2023,34(14):1724-1729.
YAN Xiaoyu,LU Yun,CHANG Feng.Cost-effectiveness analysis of serplulimab combined with chemotherapy as first-line treatment for advanced esophageal squamous cell carcinoma[J].ZHONGGUO YAOFANG,2023,34(14):1724-1729.
严小雨,路云,常峰.斯鲁利单抗联合化疗一线治疗晚期食管鳞状细胞癌的成本-效果分析 Δ[J].中国药房,2023,34(14):1724-1729. DOI： 10.6039/j.issn.1001-0408.2023.14.12.
YAN Xiaoyu,LU Yun,CHANG Feng.Cost-effectiveness analysis of serplulimab combined with chemotherapy as first-line treatment for advanced esophageal squamous cell carcinoma[J].ZHONGGUO YAOFANG,2023,34(14):1724-1729. DOI： 10.6039/j.issn.1001-0408.2023.14.12.
摘要
目的
2
从中国卫生体系角度评估斯鲁利单抗联合化疗一线治疗晚期食管鳞状细胞癌的经济性。
方法
2
构建三状态分区生存模型进行成本-效果分析。临床数据来源于ASTRUM-007临床试验，成本和效用等参数信息来自相关网站或已发表的文献，以质量调整生命年（QALYs）为产出指标计算斯鲁利单抗联合化疗对比安慰剂联合化疗治疗食管鳞状细胞癌的增量成本-效果比（ICER），并与3倍我国人均国内生产总值（GDP）的意愿支付阈值进行比较，以判断方案的经济性；采用单因素敏感性分析、概率敏感性分析评估模型的稳健性；并探讨该方案应用于程序性死亡受体-配体1联合阳性分数（PD-L1 CPS）≥10分的亚组患者和方案在慈善赠药情境下的经济性。
结果
2
在晚期或转移性食管鳞状细胞癌患者和PD-L1 CPS≥10分的亚组患者中，与安慰剂联合化疗相比，斯鲁利单抗联合化疗可以改善患者健康结果，但成本有所增加，ICER分别为599 623.64元/QALY和629 121.57元/QALY，因此斯鲁利单抗联合化疗方案不具有经济性。单因素敏感性分析表明，斯鲁利单抗的成本对ICER的影响较大；概率敏感性分析表明，基础分析结果较为稳健。情境分析结果显示，在所有患者均满足慈善赠药计划的条件下，斯鲁利单抗联合化疗方案具有经济性，与基础分析结果相比，该方案的经济性结果发生了翻转。
结论
2
从中国卫生体系角度来看，以3倍我国人均GDP为阈值，斯鲁利单抗联合化疗作为晚期食管鳞状细胞癌患者一线治疗方案是一种不具有经济性的选择；若对所有患者实施慈善赠药计划或斯鲁利单抗大幅降价，则该方案可能具有经济性。
Abstract
OBJECTIVE
2
To evaluate the cost-effectiveness of serplulimab combined with chemotherapy as first-line treatment for advanced esophageal squamous cell carcinoma from the perspective of the Chinese healthcare system.
METHODS
2
A partitioned survival model with three health states was constructed for cost-effectiveness analysis. Clinical data were extracted from ASTRUM-007. Information on parameters such as cost and health utility was derived from related websites and published literature. The quality-adjusted life years （QALYs） was used as the output index to calculate the incremental cost-effectiveness ratio （ICER）， and then compared with three times the per capita gross domestic product （GDP） in China to judge whether it was cost-effective. One-way sensitivity analysis and probabilistic sensitivity analysis were performed to evaluate the robustness of the model； the cost-effectiveness of applying this plan to subgroup patients with programmed cell death-ligand 1 combined positive score （PD-L1 CPS） ≥10 and the scheme in the context of charitable drug donations was explored.
RESULTS
2
Among advanced or metastatic oesophageal squamous cell carcinoma patients and patients with PD-L1 CPS ≥10， serplulimab combined with chemotherapy could improve health outcomes with an augmentation of cost， compared with placebo combined with chemotherapy，resulting the ICERs were 599 623.64 yuan/QALY and 629 121.57 yuan/QALY， respectively. Therefore， serplulimab combined with chemotherapy was not cost-effective. Sensitivity analysis of single factor showed that the costs of serplulimab were the crucial factor affecting the ICER； probabilistic sensitivity analysis demonstrated basic analysis results were relatively robust. The results of scenario analysis showed that when all patients met the requirements of the charitable drug donation program， serplulimab combined with chemotherapy was cost-effective； the economic outcome of this scheme was reversed compared with the results of the basic analysis.
CONCLUSIONS
2
From Chinese healthcare perspective， first-line treatment with serplulimab in combination with chemotherapy is not a cost-effective option for patients with advanced esophageal squamous cell carcinoma， but it may be an economic option to implement a charitable drug donation program for all patients or if the price of serplulimab is significantly reduced.
关键词
食管鳞状细胞癌斯鲁利单抗亚组分析成本-效果分析
Keywords
serplulimabsubgroup analysiscost-effectiveness analysis
references
SUNG H，FERLAY J，SIEGEL R L，et al. Global cancer statistics 2020：GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries[J]. CA Cancer J Clin，2021，71（3）：209-249.
国家卫生健康委员会. 中国卫生健康统计年鉴：2022[M]. 北京：中国协和医科大学出版社，2022：117-118.
NAGTEGAAL I D，ODZE R D，KLIMSTRA D，et al. The 2019 WHO classification of tumours of the digestive system[J]. Histopathology，2020，76（2）：182-188.
ARNOLD M，FERLAY J，VAN BERGE HENEGOUWEN M I，et al. Global burden of oesophageal and gastric cancer by histology and subsite in 2018[J]. Gut，2020，69（9）：1564-1571.
YANG H，WANG K L，LI Y，et al. Local ablative treatment improves survival in ESCC patients with specific metastases，2010-2016：a population-based SEER analysis[J]. Front Oncol，2022，12：783752.
LI J K，XU J Y，YANG M Y，et al. Therapeutic revolution for inoperable stage Ⅲ non-small cell lung cancer in the immune era[J]. Cancer Biol Med，2022，19（5）：569-572.
SONG Y，ZHANG B，XIN D，et al. First-line serplulimab or placebo plus chemotherapy in PD-L1-positive esophageal squamous cell carcinoma：a randomized，double-blind phase 3 trial[J]. Nat Med，2023，29（2）：473-482.
LIU L L，WANG L，CHEN L，et al. Cost-effectiveness of sintilimab plus chemotherapy versus chemotherapy alone as first-line treatment of locally advanced or metastatic oesophageal squamous cell carcinoma[J]. Front Immunol，2023，14：1092385.
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，2020：27-46.
GUYOT P，ADES A E，OUWENS M J，et al. Enhanced secondary analysis of survival data：reconstructing the data from published Kaplan-Meier survival curves[J]. BMC Med Res Methodol，2012，12：9.
LI X Y，LI W C，HOU L P. A trial-based cost-effectiveness analysis of bevacizumab and chemotherapy versus chemotherapy alone for advanced nonsquamous non-small-cell lung cancer in China[J]. Value Health Reg Issues，2019，18：1-7.
LIU Q，LUO X，PENG L B，et al. Cost-effectiveness analysis of adding ramucirumab to the first-line erlotinib treatment for untreated EGFR-mutated metastatic non-small cell lung cancer in China[J]. BMJ Open，2020，10（11）：e040691.
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2022[M]. 北京：人民卫生出版社，2022：17-25.
YE Z M，XU Z，ZENG F Y，et al. Cost-effectiveness analysis of sintilimab combined with chemotherapy versus chemotherapy alone as the first-line treatment for advanced esophageal cancer[J]. Front Pharmacol，2022，13：934275.
蔡源益，惠文，高志祥，等. 卡瑞利珠单抗联合卡铂和培美曲塞一线治疗晚期非鳞状非小细胞肺癌患者的成本-效果分析[J]. 中国现代应用药学，2021，38（23）：3015-3020.
ZHANG Q L，WU P，HE X C，et al. Cost-effectiveness analysis of camrelizumab vs. placebo added to chemotherapy as first-line therapy for advanced or metastatic esophageal squamous cell carcinoma in China[J]. Front Oncol，2021，11：790373.
国家统计局.中华人民共和国2022年国民经济和社会发展统计公报[EB/OL].（2023-02-28）[2023-03-17]. http：//www.stats.gov.cn/sj/zxfb/202302/t20230228_1919011.htmlhttp://www.stats.gov.cn/sj/zxfb/202302/t20230228_1919011.html.
MARGUET S，ADENIS A，DELAINE-CLISANT S，et al. Cost-utility analysis of continuation versus discontinuation of first-line chemotherapy in patients with metastatic squamous-cell esophageal cancer：economic evaluation alongside the E-DIS trial[J]. Value Health，2021，24（5）：676-682.
CAI H F，XU B H，LI N，et al. Cost-effectiveness analysis of camrelizumab versus chemotherapy as second-line treatment of advanced or metastatic esophageal squamous cell carcinoma[J]. Front Pharmacol，2021，12：732912.
BRIGGS A，CLAXTON K，SCULPHER M. Decision modelling for health economic evaluation[J]. Int J Epidemiol，2007，36（2）：476-477.
ZAFAR S Y，ABERNETHY A P. Financial toxicity，Part Ⅰ：a new name for a growing problem[J]. Oncology，2013，27（2）：80-81，149.
ZHENG Z W，LIN J R，ZHU H D，et al. Cost-effectiveness analysis of pembrolizumab plus chemotherapy vs. chemotherapy alone as first-line treatment in patients with esophageal squamous cell carcinoma and PD-L1 CPS of 10 or more[J]. Front Public Health，2022，10：893387.
LIU S X，DOU L，WANG K X，et al. Cost-effectiveness analysis of nivolumab combination therapy in the first-line treatment for advanced esophageal squamous-cell carcinoma[J]. Front Oncol，2022，12：899966.
RUTHERFORD M，LAMBERT P，SWEETING M，et al. Flexible methods for survival analysis TSD[EB/OL].（2022-07-08）[2023-04-11]. https：//www.sheffield.ac.uk/nice-dsu/tsds/flexible-methods-survival-analysishttps://www.sheffield.ac.uk/nice-dsu/tsds/flexible-methods-survival-analysis.
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