Zou Liangliang, Guo Guilan, Huang Yufan, Yuan Cuihua
Mindong Hospital Affiliated to Fujian Medical University, Ningde, Fujian, China.
Department of Pharmacy, Shanghai Eastern Hepatobiliary Surgery Hospital, Shanghai, China.
Front Pharmacol. 2025 May 22;16:1500729. doi: 10.3389/fphar.2025.1500729. eCollection 2025.
The RATIONALE-305 trial indicates that tislelizumab plus chemotherapy (TLE-CHM) offers clinical benefits over placebo plus chemotherapy (PLB-CHM) as a first-line treatment for patients with HER2-negative advanced gastric or gastro-oesophageal junction (G/GEJ) adenocarcinoma. Nonetheless, incorporating tislelizumab results in higher treatment costs, raising concerns about its cost-effectiveness relative to PLB-CHM. This study aimed to assess the cost-effectiveness of TLE-CHM as an initial treatment for HER2-negative advanced G/GEJ adenocarcinoma from the perspective of the Chinese healthcare system.
A Markov partitioned survival model incorporating three health states was developed to evaluate the cost-effectiveness of TLE-CHM as a first-line treatment for advanced G/GEJ adenocarcinoma. Clinical data were sourced from the RATIONALE-305 trial, with drug costs calculated at the national tender price, and additional costs and utility values derived from published literature. The outcomes measured included total costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs). Sensitivity analyses were conducted to validate the model's robustness.
TLE-CHM achieved 1.53 QALYs at a cost of $23,484.39, compared to 1.14 QALYs at $12,123.52 for PLB-CHM. The ICER for TLE-CHM versus PLB-CHM was $29,608.51 per QALY gained. Key parameters influencing the model results included PFS utility, the cost of tislelizumab, and disease progression utility. At a willingness-to-pay threshold of $19,067 per QALY, TLE-CHM had an 0.8% probability of being cost-effective compared to PLB-CHM.
From the perspective of the Chinese healthcare system, TLE-CHM is not a cost-effective first-line treatment for advanced G/GEJ adenocarcinoma compared to chemotherapy.
RATIONALE - 305试验表明，对于人表皮生长因子受体2（HER2）阴性的晚期胃癌或胃食管交界（G/GEJ）腺癌患者，替雷利珠单抗联合化疗（TLE-CHM）作为一线治疗方案比安慰剂联合化疗（PLB-CHM）具有临床优势。尽管如此，加入替雷利珠单抗会导致治疗成本增加，引发了对其相对于PLB-CHM的成本效益的担忧。本研究旨在从中国医疗保健系统的角度评估TLE-CHM作为HER2阴性晚期G/GEJ腺癌初始治疗方案的成本效益。
构建了一个包含三种健康状态的马尔可夫分区生存模型，以评估TLE-CHM作为晚期G/GEJ腺癌一线治疗方案的成本效益。临床数据来源于RATIONALE - 305试验，药物成本按国家招标价格计算，额外成本和效用值来自已发表的文献。测量的结果包括总成本、质量调整生命年（QALY）和增量成本效益比（ICER）。进行敏感性分析以验证模型的稳健性。
TLE-CHM方案获得1.53个QALY，成本为23,484.39美元；相比之下，PLB-CHM方案获得1.14个QALY，成本为12,123.52美元。TLE-CHM相对于PLB-CHM的ICER为每获得一个QALY 29,608.51美元。影响模型结果的关键参数包括无进展生存期（PFS）效用、替雷利珠单抗的成本和疾病进展效用。在每QALY支付意愿阈值为19,067美元时，与PLB-CHM相比，TLE-CHM具有成本效益的概率为0.8%。
从中国医疗保健系统的角度来看，与单纯化疗相比，TLE-CHM并非HER2阴性晚期G/GEJ腺癌具有成本效益的一线治疗方案。
