Background/Objectives: Sugemalimab demonstrated clinical efficacy in the GEMSTONE-303 trial, but its cost-effectiveness remains unclear. This study aims to evaluate the cost-effectiveness of sugemalimab in combination with chemotherapy (CAPOX) as a first-line treatment for patients with advanced or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, compared to chemotherapy alone, from the perspective of Taiwan’s healthcare payer. Methods: A partitioned survival model was developed to simulate outcomes over a 40-year time horizon, and model parameters were derived from GEMSTONE-303 and the wider literature. Health benefits were measured in quality-adjusted life-years (QALYs), and only direct medical costs were included, with both discounted at an annual rate of 3%. The willingness-to-pay threshold was set at three times the 2024 GDP per capita. Deterministic and probabilistic sensitivity analyses were conducted alongside scenario analyses. Results: Compared to capecitabine and oxaliplatin (CAPOX) alone, adding sugemalimab yielded an incremental gain of 0.39 QALYs at an additional cost of USD 47,020, resulting in an incremental net monetary benefit of −USD 7478. Conclusions: Sugemalimab plus CAPOX is not cost-effective for advanced or metastatic G/GEJ adenocarcinoma from the Taiwan payer’s perspective. Achieving cost-effectiveness would require a 20–30% price reduction for sugemalimab (to USD 1204–USD 1376 per 600 mg), assuming first-line therapy is administered for the median treatment duration observed in the GEMSTONE-303 trial. If reimbursement continued until disease progression, a reduction of approximately 68% would be required (USD 550 per 600 mg).
背景/目的：舒格利单抗在GEMSTONE-303试验中显示出临床疗效，但其成本效益尚不明确。本研究旨在从台湾地区医疗支付方的角度，评估舒格利单抗联合化疗（CAPOX）对比单纯化疗，作为晚期或转移性胃或胃食管结合部（G/GEJ）腺癌一线治疗的成本效益。方法：构建分区生存模型模拟40年时间范围内的结局，模型参数来源于GEMSTONE-303试验及相关文献。健康效益以质量调整生命年（QALYs）衡量，仅纳入直接医疗成本，并以3%的年率进行贴现。支付意愿阈值设定为2024年人均GDP的三倍。研究同时进行了确定性及概率敏感性分析以及情境分析。结果：与单纯使用卡培他滨联合奥沙利铂（CAPOX）相比，加用舒格利单抗可带来0.39 QALYs的增量效益，但需增加47,020美元的成本，导致增量净货币效益为-7,478美元。结论：从台湾地区支付方的角度来看，舒格利单抗联合CAPOX方案用于晚期或转移性G/GEJ腺癌治疗不具有成本效益。若假设一线治疗按GEMSTONE-303试验观察到的中位治疗时长给药，舒格利单抗需降价20-30%（即每600毫克价格降至1,204-1,376美元）方可实现成本效益。若报销持续至疾病进展，则需降价约68%（即每600毫克550美元）。
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