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舒格利单抗联合化疗作为一线治疗PD-L1 CPS≥5的晚期胃或胃食管交界腺癌的成本效益分析

Cost-effective analysis of sugemalimab plus chemotherapy as first-line treatment for advanced gastric or gastroesophageal junction adenocarcinoma with PD-L1 CPS ≥5.

作者信息

Zhang Yalan, He Ying, Chen Ruijia, You Maojin

机构信息

Department of Pharmacy, The Second Affiliated Hospital of Fujian Medical University, Quanzhou, Fujian, China.

Department of Emergency Medicine, Mindong Hospital Affiliated to Fujian Medical University, Ningde, Fujian, China.

出版信息

Front Public Health. 2025 Aug 22;13:1604372. doi: 10.3389/fpubh.2025.1604372. eCollection 2025.

Abstract

BACKGROUND

Results from the GEMSTONE-303 trial indicate that compared with placebo plus capecitabine and oxaliplatin (PLA-CAP), sugemalimab plus capecitabine and oxaliplatin (SUG-CAP) as first-line therapy provides clinical benefits for patients with advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma with programmed cell death ligand 1 (PD-L1) combined positive score (CPS) ≥5. However, the addition of sugemalimab increases medical costs. This study aimed to assess the cost-effectiveness of SUG-CAP vs. PLA-CAP for the first-line treatment of advanced G/GEJ adenocarcinoma with PD-L1 CPS ≥5 from the perspective of China's healthcare system.

METHODS

A Markov model with three health states was developed to compare the cost-effectiveness of SUG-CAP and PLA-CAP. Clinical data were obtained from the GEMSTONE-303 trial, drug costs were determined based on national bidding prices, and other costs and utility values were obtained from published literature. Outcomes included total costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs). Sensitivity analysis was used to verify the robustness of the model.

RESULTS

The SUG-CAP incurred costs of $70,673.28 and gained 1.28 QALYs. In the PLA-CAP, the effectiveness was 1.00 QALYs at a cost of $11,241.52. Compared with PLA-CAP, SUG-CAP yielded an increase of 0.28 QALYs at an incremental cost of $59,431.76. The ICER for SUG-CAP vs. PLA-CAP was $217,686.71 per QALY, which exceeds the preset willingness-to-pay (WTP) threshold of $41,511 per QALY, with a 0% probability of being cost-effective. The parameters that significantly affected the model were the cost of sugemalimab, progression-free survival (PFS) utility, and discount rate.

CONCLUSION

From the perspective of China's healthcare system, SUG-CAP as first-line therapy for advanced G/GEJ adenocarcinoma with PD-L1 CPS ≥5 is not cost-effective compared with chemotherapy alone.

摘要

背景

GEMSTONE-303试验结果表明,与安慰剂联合卡培他滨和奥沙利铂(PLA-CAP)相比,舒格利单抗联合卡培他滨和奥沙利铂(SUG-CAP)作为一线治疗方案,为程序性细胞死亡配体1(PD-L1)联合阳性评分(CPS)≥5的晚期胃癌或胃食管交界(G/GEJ)腺癌患者带来了临床益处。然而,添加舒格利单抗会增加医疗成本。本研究旨在从中国医疗体系的角度评估SUG-CAP与PLA-CAP用于一线治疗PD-L1 CPS≥5的晚期G/GEJ腺癌的成本效益。

方法

构建了一个具有三种健康状态的马尔可夫模型,以比较SUG-CAP和PLA-CAP的成本效益。临床数据来自GEMSTONE-303试验,药物成本根据国家招标价格确定,其他成本和效用值则从已发表的文献中获取。结果包括总成本、质量调整生命年(QALY)和增量成本效益比(ICER)。采用敏感性分析来验证模型的稳健性。

结果

SUG-CAP产生的成本为70,673.28美元,获得1.28个QALY。在PLA-CAP组中,有效性为1.00个QALY,成本为11,24

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c019/12411535/b01083651198/fpubh-13-1604372-g0001.jpg

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