Table 8_Cost-effectiveness analysis of sugemalimab combined with chemotherapy as first-line treatment for advanced gastric cancer.xlsx

ObjectiveBased on findings from the GEMSTONE-303 trial, the sugemalimab plus capecitabine and oxaliplatin regimen showed superior clinical efficacy compared to chemotherapy alone in advanced gastric cancer patients. This economic evaluation study assesses the cost-effectiveness of sugemalimab combination therapy within China’s healthcare system framework.
MethodsA partitioned survival model was constructed based on data from the GEMSTONE-303 study, with a cycle length of 3 weeks. The model simulated patients’ direct medical costs and quality-adjusted life years (QALYs) over a 10-year period. The incremental cost-effectiveness ratio (ICER) was used as the evaluation metric, comparing the ICER against the willingness-to-pay (WTP) threshold (3 times China’s per capita GDP in 2024, 287,391 CNY/QALY). One-way sensitivity analysis and probabilistic sensitivity analysis were conducted to assess the robustness of the results.
ResultsThe base-case analysis showed that the sugemalimab regimen provided greater health benefits compared to the placebo group (1.36 QALYs vs. 1.24 QALYs) but incurred significantly higher costs (271,041.24 CNY vs. 44,174.69 CNY), yielding an ICER of 1,890,554.58 CNY/QALY. One-way sensitivity analysis indicated that the utility values for the progressive disease (PD) state, progression-free survival (PFS) state, and the cost of sugemalimab had the most substantial impact on the ICER. Probabilistic sensitivity analysis demonstrated stable results, with a 0% probability that the sugemalimab combination regimen was cost-effective.
ConclusionUnder the current economic conditions in China, sugemalimab combined with chemotherapy as a first-line treatment for advanced gastric cancer is not cost-effective.

研究目标：基于GEMSTONE-303试验的研究结果，舒格利单抗（sugemalimab）联合卡培他滨（capecitabine）与奥沙利铂（oxaliplatin）方案，对比单纯化疗在晚期胃癌患者中展现出更优的临床疗效。本卫生经济学评价研究旨在评估中国医疗卫生体系框架下该联合疗法的成本效果。
研究方法：本研究基于GEMSTONE-303研究的数据构建分区生存模型，模型循环周期为3周。该模型模拟了10年随访周期内患者的直接医疗成本与质量调整生命年（quality-adjusted life years, QALYs）。本研究以增量成本效果比（incremental cost-effectiveness ratio, ICER）作为评价指标，将ICER与意愿支付阈值（willingness-to-pay, WTP）进行对比，该阈值设定为2024年中国人均GDP的3倍，即287391元/质量调整生命年。通过单因素敏感性分析与概率敏感性分析评估研究结果的稳健性。
研究结果：基础案例分析显示，相较于安慰剂组，舒格利单抗联合疗法可带来更优的健康获益（1.36个QALYs vs 1.24个QALYs），但医疗成本显著更高（271041.24元 vs 44174.69元），对应的增量成本效果比为1890554.58元/QALY。单因素敏感性分析结果表明，疾病进展（progressive disease, PD）状态、无进展生存（progression-free survival, PFS）状态的效用值以及舒格利单抗的成本对ICER的影响最为显著。概率敏感性分析证实研究结果稳健，舒格利单抗联合疗法具备成本效果的概率为0%。
研究结论：基于中国当前的卫生经济环境，舒格利单抗联合化疗作为晚期胃癌一线治疗方案并不具备成本效果。