Xiang Zuojuan, Li Zhengxiong, Chen Xiaojuan, Fu Yingzhou
Department of Pharmacy, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Hunan Cancer Hospital, Changsha, China.
School of Medical Informatics and Engineering, Xuzhou Medical University, Xuzhou, China.
Front Immunol. 2025 Apr 3;16:1562875. doi: 10.3389/fimmu.2025.1562875. eCollection 2025.
Immunotherapy has made significant advancements in cervical cancer (CC) treatment; however, its efficacy remains limited in programmed death ligand 1 (PD-L1)-negative patients. Cadonilimab, the first bispecific antibody targeting both programmed death 1 (PD-1) and cytotoxic T lymphocyte-associated antigen-4 (CTLA-4), demonstrated superior efficacy and manageable safety as a first-line treatment for persistent, recurrent, or metastatic CC (p/r/m CC) in the phase III COMPASSION-16 trial. Notably, it showed significant survival benefits in PD-L1-negative patients. This study aimed to evaluate its cost-effectiveness from the perspective of the Chinese healthcare system.
A partitioned survival model was developed based on data derived from the COMPASSION-16 trial. The model utilized a 3-week cycle length and a 10-year time horizon. The primary outcomes included costs, quality-adjusted life-years (QALYs), incremental cost-effectiveness ratio (ICER), incremental net monetary benefit (INMB), and incremental net health benefit (INHB). Additionally, sensitivity analyses, scenario analyses, and subgroup analyses were performed.
The cadonilimab plus chemotherapy regimen provided an additional 0.61 QALYs compared to chemotherapy alone, at an incremental cost of $42,486.54. This yielded an ICER of $70,220.88/QALY, exceeding the willingness-to-pay threshold of $38,042/QALY. The corresponding INMB and INHB were -$19,469.55 and -0.51 QALYs, respectively. Consequently, cadonilimab plus chemotherapy was not deemed to be cost-effective. Sensitivity analyses showed that the results remained consistent when each parameter varied within the predetermined range, indicating the model's robustness. Subgroup analyses demonstrated no significant positive correlation between economic outcomes and PD-L1 expression levels. Notably, in the subgroup of patients who did not receive bevacizumab, cadonilimab plus chemotherapy emerged as a cost-effective alternative.
In China, cadonilimab plus chemotherapy is not considered cost-effective compared to standard chemotherapy as a first-line treatment for the general p/r/m CC population. However, it represents a cost-effective option for patients ineligible for bevacizumab therapy.
免疫疗法在宫颈癌（CC）治疗方面取得了重大进展；然而，其疗效在程序性死亡配体1（PD-L1）阴性患者中仍然有限。卡度尼利单抗是首个同时靶向程序性死亡1（PD-1）和细胞毒性T淋巴细胞相关抗原4（CTLA-4）的双特异性抗体，在III期COMPASSION-16试验中，作为持续性、复发性或转移性CC（p/r/m CC）的一线治疗方案，显示出卓越的疗效和可控的安全性。值得注意的是，它在PD-L1阴性患者中显示出显著的生存获益。本研究旨在从中国医疗保健系统的角度评估其成本效益。
基于COMPASSION-16试验的数据建立了一个分区生存模型。该模型采用3周的周期长度和10年的时间范围。主要结局包括成本、质量调整生命年（QALY）、增量成本效益比（ICER）、增量净货币效益（INMB）和增量净健康效益（INHB）。此外，还进行了敏感性分析、情景分析和亚组分析。
与单纯化疗相比，卡度尼利单抗联合化疗方案可额外获得0.61个QALY，增量成本为42486.54美元。这产生了一个70220.88美元/QALY的ICER，超过了38042美元/QALY的支付意愿阈值。相应的INMB和INHB分别为-19469.55美元和-0.51个QALY。因此，卡度尼利单抗联合化疗被认为不具有成本效益。敏感性分析表明，当每个参数在预定范围内变化时，结果保持一致，表明模型的稳健性。亚组分析表明，经济结局与PD-L1表达水平之间无显著正相关。值得注意的是，在未接受贝伐单抗治疗的患者亚组中，卡度尼利单抗联合化疗是一种具有成本效益的替代方案。
在中国，对于一般的p/r/m CC人群，作为一线治疗方案，与标准化疗相比，卡度尼利单抗联合化疗不被认为具有成本效益。然而，对于不符合贝伐单抗治疗条件的患者，它是一种具有成本效益的选择。
