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

Cost-utility analysis of sugemalimab combined with chemotherapy as first-line treatment for advanced esophageal squamous cell carcinoma with high PD-L1 expression

目的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。结果联合方案相比于单用化疗方案的ICER为288430.35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(173354.52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(173354.52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6107.41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 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 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).Costutility 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 The ICER of the combination therapy compared to chemotherapy alone was 288430.35 yuan/QALY,significantly exceeding the willingness-to-pay(WTP)threshold of 173354.52 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(173354.52 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 6107.41 yuan per box(600 mg).CONCLUSIONS 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%.