Long Rong, Kuang Weilu, Zhou Qin
Department of Oncology, Xiangya Hospital, Central South University, Changsha, China.
National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, Central South University, Changsha, China.
Transl Lung Cancer Res. 2025 May 30;14(5):1622-1634. doi: 10.21037/tlcr-2024-1053. Epub 2025 May 22.
A highly anticipated multicenter phase 3 HARMONi-A study (NCT05184712) showed that ivonescimab plus chemotherapy greatly enhanced progression-free survival (PFS) in individuals with non‑squamous non-small cell lung cancer (nsq-NSCLC) after treatment with epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) with an acceptable safety profile. This investigation systematically analyzed the cost-effectiveness of treating advanced/metastatic nsq-NSCLC with EGFR mutations with a combination of ivonescimab and chemotherapy from the standpoint of the Chinese healthcare system.
A decision-embedded Markov model with three specific health states was established for predicting the economic and health outcomes associated with ivonescimab plus chemotherapy or chemotherapy alone over a 10-year time frame. The key health outcomes in the study included life-years (LYs), quality-adjusted life-years (QALYs), incremental cost-effectiveness ratios (ICERs), and incremental net health benefits (INHBs). Extensive sensitivity analyses were performed to assess the stability and uncertainty of the model with parameter adjustments. Additionally, cohort analyses for relevant subgroups were performed.
The base-case overall cost (efficacy) of ivonescimab plus chemotherapy was $41,354 (0.90 QALYs), which was more than $35,166 and 0.13 QALYs of chemotherapy alone. This yielded an ICER of $277,594 per additional QALY with a corresponding INHB of -0.82 QALYs, which was significantly higher than the willingness-to-pay (WTP) threshold of $36,997/QALY in China. The sensitivity analyses indicated that the ivonescimab cost was the dominant driver for ICER, while the model results remained stable irrespective of variations in the model parameters within given ranges.
The findings indicate that for Chinese patients with nsq-NSCLC with EGFR who did not respond to EGFR-TKI therapy, the ivonescimab-chemotherapy combination is not cost-effective in the absence of price adjustment or any current charitable aid program.
一项备受期待的多中心3期HARMONi-A研究（NCT05184712）表明，对于接受表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI）治疗后出现非鳞状非小细胞肺癌（nsq-NSCLC）的患者，伊沃西单抗联合化疗可显著提高无进展生存期（PFS），且安全性可接受。本研究从中国医疗体系的角度，系统分析了伊沃西单抗联合化疗治疗具有EGFR突变的晚期/转移性nsq-NSCLC的成本效益。
建立了一个具有三种特定健康状态的决策嵌入马尔可夫模型，用于预测10年内伊沃西单抗联合化疗或单纯化疗相关的经济和健康结局。研究中的关键健康结局包括生命年（LYs）、质量调整生命年（QALYs）、增量成本效益比（ICERs）和增量净健康效益（INHBs）。进行了广泛的敏感性分析，以通过参数调整评估模型的稳定性和不确定性。此外，还对相关亚组进行了队列分析。
伊沃西单抗联合化疗的基础病例总成本（疗效）为41,354美元（0.90 QALYs），高于单纯化疗的35,166美元和0.13 QALYs。这产生了每增加一个QALY的ICER为277,594美元，相应的INHB为-0.82 QALYs，显著高于中国每QALY 36,997美元的支付意愿（WTP）阈值。敏感性分析表明，伊沃西单抗成本是ICER的主要驱动因素，而在给定范围内，无论模型参数如何变化，模型结果均保持稳定。
研究结果表明，对于中国EGFR突变且对EGFR-TKI治疗无反应的nsq-NSCLC患者，在没有价格调整或当前任何慈善援助计划的情况下，伊沃西单抗-化疗联合方案不具有成本效益。
