Jiang Yuan, Li Yue, Wang Larry X W
Department of Pharmacy, Tianjin Union Medical Center, 190, Jieyuan Road, Hongqiao District, Tianjin, People's Republic of China.
Department of Pharmacy, Clinical Medical College of Tianjin Medical University, 167, Xueyuan Road, Binhai District, Tianjin, People's Republic of China.
Int J Clin Pharm. 2022 Apr;44(2):499-506. doi: 10.1007/s11096-021-01372-6. Epub 2022 Jan 28.
Background Nivolumab plus standard chemotherapy has significant clinical benefits for unresectable advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma (GC/GEJC/EAC). However, nivolumab is expensive, necessitating a cost-effectiveness evaluation. Aim This study aimed to evaluate the cost-effectiveness of nivolumab plus standard chemotherapy vs. chemotherapy alone for unresectable advanced or metastatic GC/GEJC/EAC from the Chinese healthcare system perspective. This study was based on randomized clinical trial data from the CheckMate-649 clinical trial (NCT02872116) published in Lancet (June 2021). Method A Markov model was used to assess the cost-effectiveness of nivolumab plus standard chemotherapy versus chemotherapy alone for unresectable advanced or metastatic GC/GEJC/EAC. Drug costs were collected from Tianjin Medical Purchasing Center in 2021, and utility values of health states were obtained from the literature. The reliability of model was assessed with one-way and probabilistic sensitivity analyses. Main outcome measure The main outcomes were costs, quality-adjusted life-years (QALYs) and the incremental cost-effectiveness ratio (ICER). Results Over a 10-year horizon, the outputs were 1.19 QALYs at a cost of $78,814.9 and 0.88 QALYs at a cost of $19,522.3 with nivolumab plus chemotherapy and chemotherapy alone, respectively. The ICER for nivolumab plus chemotherapy versus chemotherapy alone was $191,266/QALY, exceeding the willingness-to-pay (WTP) threshold ($33,436/QALY). One-way sensitivity analysis revealed nivolumab cost was the most influential parameter. Conclusion Adding nivolumab is not cost-effective for unresectable advanced or metastatic GC/GEJC/EAC in the current Chinese healthcare environment.
背景 纳武利尤单抗联合标准化疗对不可切除的晚期或转移性胃癌、胃食管交界癌和食管腺癌（GC/GEJC/EAC）具有显著的临床益处。然而，纳武利尤单抗价格昂贵，因此有必要进行成本效益评估。目的 本研究旨在从中国医疗保健系统的角度评估纳武利尤单抗联合标准化疗与单纯化疗相比用于不可切除的晚期或转移性GC/GEJC/EAC的成本效益。本研究基于发表于《柳叶刀》（2021年6月）的CheckMate - 649临床试验（NCT02872116）的随机临床试验数据。方法 采用马尔可夫模型评估纳武利尤单抗联合标准化疗与单纯化疗相比用于不可切除的晚期或转移性GC/GEJC/EAC的成本效益。2021年从天津市药品采购中心收集药品成本，并从文献中获取健康状态的效用值。通过单向和概率敏感性分析评估模型的可靠性。主要结局指标 主要结局为成本、质量调整生命年（QALY）和增量成本效益比（ICER）。结果 在10年的时间范围内，纳武利尤单抗联合化疗组的产出为1.19个QALY，成本为78,814.9美元；单纯化疗组的产出为0.88个QALY，成本为19,522.3美元。纳武利尤单抗联合化疗与单纯化疗相比的ICER为191,266美元/QALY，超过了支付意愿（WTP）阈值（33,436美元/QALY）。单向敏感性分析显示纳武利尤单抗成本是最具影响力的参数。结论 在当前中国医疗环境下，对于不可切除的晚期或转移性GC/GEJC/EAC患者，添加纳武利尤单抗不具有成本效益。
