Yu Cuicui, Wu Yingqi, Geng Yadi, Yan Hui, Zhu Pengli, Ji Peng, Wu Fei, Ning Lijuan, Feng Yubin, Shen Aizong
Department of Pharmacy, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, 230001, China.
Technology of China/Anhui Technology Center for Clinical Comprehensive Evaluation of Drugs, Hefei, 230001, China.
Health Econ Rev. 2025 Jan 10;15(1):2. doi: 10.1186/s13561-024-00588-2.
The ORIENT-15 double-blind randomized controlled trial demonstrated that the addition of sintilimab to chemotherapy for locally advanced or metastatic oesophageal squamous cell carcinoma (OSCC) resulted in better clinical outcomes. In this analysis, we sought to evaluate the cost-effectiveness of sintilimab as a first-line treatment for locally advanced or metastatic OSCC from a healthcare system perspective in China.
A partitioned survival model was constructed to perform a cost-effectiveness analysis comparing chemotherapy alone with sintilimab for locally advanced or metastatic OSCC patients. Clinical data were obtained from the ORIENT-15 trial and extrapolated to 10 years. Health state utilities and costs were sourced from the literature and from public healthcare institutions. The primary outcomes included the incremental cost-effectiveness ratio (ICER) and quality-adjusted life-years (QALYs). Two different sensitivity analyses, one-way and probabilistic, were performed to assess model uncertainty.
Sintilimab-based chemotherapy was more costly ($31699.21 vs. $20687.42) and more effective (0.74 vs. 0.53) than placebo-based chemotherapy, resulting in an ICER of $51908.19 /QALY, which is greater than the willingness-to-pay (WTP) threshold of China ($38223/QALY). Sensitivity analysis demonstrated that the PFS and cost of sintilimab were the major influencing factors affecting the results.
In patients with locally advanced or metastatic OSCC, sintilimab chemotherapy could improve survival time and health benefits compared with traditional chemotherapy, but the present analysis suggests that sintilimab is not a cost-effective treatment option in China.
ORIENT-15双盲随机对照试验表明，对于局部晚期或转移性食管鳞状细胞癌（OSCC）患者，在化疗基础上加用信迪利单抗可带来更好的临床疗效。在本分析中，我们试图从中国医疗保健系统的角度评估信迪利单抗作为局部晚期或转移性OSCC一线治疗的成本效益。
构建一个分段生存模型，对局部晚期或转移性OSCC患者单独使用化疗与使用信迪利单抗进行成本效益分析。临床数据来自ORIENT-15试验，并外推至10年。健康状态效用值和成本数据来源于文献及公共医疗机构。主要结局指标包括增量成本效益比（ICER）和质量调整生命年（QALY）。进行了两种不同的敏感性分析，即单向敏感性分析和概率敏感性分析，以评估模型的不确定性。
与基于安慰剂的化疗相比，基于信迪利单抗的化疗成本更高（31699.21美元对20687.42美元）且疗效更佳（0.74对0.53），ICER为每QALY 51908.19美元，高于中国的支付意愿阈值（38223美元/QALY）。敏感性分析表明，信迪利单抗的无进展生存期（PFS）和成本是影响结果的主要因素。
对于局部晚期或转移性OSCC患者，与传统化疗相比，信迪利单抗化疗可改善生存时间和健康获益，但本分析表明，在中国，信迪利单抗并非具有成本效益的治疗选择。
