Data_Sheet_1_Cost-effectiveness analysis of sugemalimab vs. placebo, in combination with chemotherapy, for treatment of first-line metastatic NSCLC in China.DOCX

ObjectiveThe purpose of this study was to estimate the cost-effectiveness of sugemalimab plus chemotherapy (SC) vs. placebo plus chemotherapy (PC), as the first-line treatment for patients with non-small cell lung cancer (NSCLC) in China.
Material and methodsA three-state Markov model with a cycle of 3 weeks was built to assess the incremental cost-effectiveness ratio (ICER) of SC vs. PC as first-line treatment for patients with NSCLC over a 10-year horizon from Chinese health care perspective. Time-dependency transition probability and safety data were derived from a multicenter, randomized, double-blind, phase 3 clinical trial performed in China (GEMSTONE-302). Primary model outcomes included the costs in US dollars and health outcomes in quality-adjusted life-years (QALYs) and the ICER under a willingness-to-pay (WTP) threshold of $37,663/QALYs. Deterministic, scenario and probabilistic sensitivity analysis were employed to investigate the robustness of model outcomes.
ResultsIn base-case analysis, compared with PC, first-line SC for intention-to-treat (ITT) population gained an additional 0.57 QALYs with an incremental cost of $62,404.15, resulting in an ICER of $109,480.97/QALYs gained. When a patient assistance program (PAP) was available, the ICER decreased to $52,327.02/QALYs. In subgroup analysis, the ICER values were above the WTP threshold with or without PAP. Sensitivity analysis results suggested that the model outcomes were reliable.
ConclusionFrom the perspective of Chinese healthcare system, the SC was not cost-effective in comparison to PC as first-line treatment for NSCLC, regardless of PD-L1 tumor expression level and pathological subtype.

研究目的 本研究旨在评估舒格利单抗（sugemalimab）联合化疗（SC）对比安慰剂联合化疗（PC）作为中国非小细胞肺癌（NSCLC）患者一线治疗方案的成本-效果性。
材料与方法 本研究从中国医疗卫生体系视角出发，以10年为研究时限，构建以3周为循环周期的三状态马尔可夫模型（Markov model），用于评估舒格利单抗联合化疗对比安慰剂联合化疗作为非小细胞肺癌患者一线治疗方案的增量成本-效果比（ICER）。时间依赖性转移概率及安全性数据来源于一项在中国开展的多中心、随机、双盲Ⅲ期临床试验GEMSTONE-302。模型主要结局指标包括以美元计价的医疗成本、以质量调整生命年（QALYs）衡量的健康结局，以及在意愿支付阈值（WTP）为37663美元/质量调整生命年条件下的增量成本-效果比。本研究采用确定性分析、场景分析及概率敏感性分析以验证模型结局的稳健性。
结果 基于意向治疗（ITT）人群的基础案例分析显示，相较于安慰剂联合化疗方案，舒格利单抗联合化疗一线治疗可额外获得0.57个质量调整生命年，增量成本为62404.15美元，增量成本-效果比为109480.97美元/每获得1个质量调整生命年。当启用患者援助项目（PAP）时，增量成本-效果比可降至52327.02美元/质量调整生命年。亚组分析结果显示，无论是否启用患者援助项目，各亚组的增量成本-效果比均高于意愿支付阈值。敏感性分析结果表明，模型结局具有良好的稳健性。
结论 从中国医疗卫生体系视角出发，无论患者PD-L1肿瘤表达水平及病理亚型如何，舒格利单抗联合化疗作为非小细胞肺癌一线治疗方案的成本-效果性均劣于安慰剂联合化疗方案。