Hou Yibing, Yang Shuo, Wang Xiaohui, Zhao Shan, Liu Huanlong, Kang Shuo
Department of Pharmacy, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.
School of Pharmacy, Hebei Medical University, Shijiazhuang, Hebei, China.
Front Pharmacol. 2025 Aug 22;16:1654177. doi: 10.3389/fphar.2025.1654177. eCollection 2025.
The present study aimed to evaluate the cost-effectiveness of pembrolizumab combined with chemotherapy versus placebo plus chemotherapy for patients with previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer from the perspective of the Chinese healthcare system.
A Markov model was developed to track patients' transitions over 3-week cycles and evaluate the health and economic outcomes over a 10-year horizon for the two competing treatments. The survival data were gathered from the KEYNOTE-355 trial, and cost and utility values were obtained from the published studies. Total costs, life-years, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio (ICER) were the model outcomes. We conducted analysis based on patients' programmed death-ligand 1 (PD-L1) combined positive score (CPS), including subgroups with CPS≥10, CPS≥1, and the intention-to-treat population. One-way sensitivity analysis, probabilistic sensitivity analysis and scenario analysis were performed to examine the robustness of the model results.
In the base case analysis for patients highly expressing PD-L1 (CPS≥10), pembrolizumab plus chemotherapy yielded a marginal cost of $85,838.75 and an additional 0.47 QALYs, resulting in an ICER of $184,030.56 per additional QALY gained, which exceeded the willingness-to-pay (WTP) threshold of $38,224 per QALY in China. And the ICERs were $319,506.90/QALY for patients lowly expressing PD-L1 (CPS≥1) and $776,786.75/QALY for the intention-to-treat population. Sensitivity analyses confirmed the robustness of the model outcomes. Scenario analysis demonstrated that price reductions for pembrolizumab could enhance its likelihood of achieving cost-effectiveness.
The findings of this cost-effectiveness analysis suggest that pembrolizumab plus chemotherapy was not a cost-effective treatment for patients with previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer in China.
本研究旨在从中国医疗体系的角度，评估帕博利珠单抗联合化疗与安慰剂联合化疗用于既往未接受治疗的局部复发性不可手术或转移性三阴性乳腺癌患者的成本效益。
构建马尔可夫模型，以跟踪患者在3周周期内的病情转变，并评估两种竞争性治疗方案在10年期间的健康和经济结局。生存数据取自KEYNOTE-355试验，成本和效用值来自已发表的研究。模型结果包括总成本、生命年、质量调整生命年（QALY）和增量成本效益比（ICER）。我们根据患者的程序性死亡配体1（PD-L1）联合阳性评分（CPS）进行分析，包括CPS≥10、CPS≥1的亚组以及意向性治疗人群。进行了单向敏感性分析、概率敏感性分析和情景分析，以检验模型结果的稳健性。
在高表达PD-L1患者（CPS≥10）的基础病例分析中，帕博利珠单抗联合化疗的边际成本为85,838.
