Fudan University Shanghai Cancer Center (Xiamen), Xiamen, 361005, China.
Department of Pharmacy, Fujian Medical University Union Hospital, Fuzhou, 350100, China.
Orphanet J Rare Dis. 2023 Oct 16;18(1):326. doi: 10.1186/s13023-023-02925-w.
The regimen of nivolumab plus ipilimumab (NI) has been recommended by the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology-Malignant Pleural Mesothelioma (Version 1.2022) and Chinese Guidelines for the Clinical Diagnosis and Treatment of Malignant Pleural Mesothelioma (2021 edition) as the first-line treatment for Malignant Pleural Mesothelioma (MPM). But whether immunotherapy has a financial advantage over conventional chemotherapy (pemetrexed plus cisplatin/carboplatin, C) is uncertain.
Based on survival and safety data from the CheckMate 743 clinical trial (NCT02899299), a partitioned survival model was constructed using TreeAge Pro2022 software. The model cycle was set to 1 month and the study period was 10 years. The output indicators included total cost, quality-adjusted life year (QALY) and incremental cost-effectiveness ratio (ICER). One-way and probabilistic sensitivity analyses were used to assess the robustness of the results, considering only direct medical costs.
The ICER for group NI versus Group C was $375,656/QALY in all randomized patients, $327,943/QALY in patients with epithelioid histology, and $115,495/QALY in patients with non-epithelioid histology. The ICERs of all three different populations all exceeded the willingness-to-pay threshold (three times the per capita gross domestic product of China in 2021). The results of univariate sensitivity analysis showed that the price of pemetrexed and nivolumab had great influence on the analysis results. The results of the probabilistic sensitivity analysis show that the probability of the NI scheme being more economical in all three different populations was 0.
From the perspective of the Chinese healthcare system, in patients with unresectable MPM, NI has no economic advantage over C.
纳武利尤单抗联合伊匹单抗（NI）方案已被美国国家综合癌症网络临床实践指南-恶性胸膜间皮瘤（第 1.2022 版）和中国恶性胸膜间皮瘤临床诊断与治疗指南（2021 年版）推荐为恶性胸膜间皮瘤（MPM）的一线治疗方案。但免疫治疗是否比传统化疗（培美曲塞联合顺铂/卡铂，C）具有经济优势尚不确定。
基于 CheckMate 743 临床试验（NCT02899299）的生存和安全性数据，使用 TreeAge Pro2022 软件构建了分割生存模型。模型周期设置为 1 个月，研究期为 10 年。输出指标包括总费用、质量调整生命年（QALY）和增量成本效益比（ICER）。采用单因素敏感性分析和概率敏感性分析来评估结果的稳健性，仅考虑直接医疗成本。
在所有随机患者中，NI 组与 C 组的 ICER 为 375656 美元/QALY，上皮样组织学患者为 327943 美元/QALY，非上皮样组织学患者为 115495 美元/QALY。所有三个不同人群的 ICER 均超过了意愿支付阈值（2021 年中国人均国内生产总值的三倍）。单因素敏感性分析结果表明，培美曲塞和纳武利尤单抗的价格对分析结果有很大影响。概率敏感性分析结果表明，在所有三个不同人群中，NI 方案更经济的概率均为 0。
从中国医疗保健系统的角度来看，在不可切除的 MPM 患者中，NI 方案相对于 C 方案没有经济优势。
