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

目的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599623.64元/QALY和629121.57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。

OBJECTIVE 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 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 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 599623.64 yuan/QALY and 629121.57 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 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.