Department of Clinical Pharmacy and Healthcare Science, Faculty of Pharmacy, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University.
Biol Pharm Bull. 2022;45(7):895-903. doi: 10.1248/bpb.b22-00150.
A model-based, cost-effectiveness analysis was conducted to evaluate the difference in cost-effectiveness of nivolumab (NIVO), between first-line therapy in combination with chemotherapy and third-line or later monotherapy for patients with unresectable, advanced or recurrent gastric or gastro-esophageal junction cancer, with the aim of supporting the economic evaluation of healthcare in Japan. Data on overall survival and progression-free survival were obtained from the phase 3 clinical trials, ATTRACTION-4 and ATTRACTION-2. A partitioned survival model was developed to predict costs and outcomes. Direct medical costs were considered from the perspective of the Japanese national health insurance (NHI) payer. The model time horizon was set to 10 years. Health outcomes were defined as life years (LYs) and quality-adjusted life years (QALYs) gained. The incremental cost-effectiveness ratio (ICER) of NIVO compared to the control group was estimated. Sensitivity analyses were performed to assess the uncertainty of parameter setting. A willingness-to-pay threshold of 15 million JPY (Japanese yen) was used. Compared to each control group, the ICERs for NIVO treatment per 1 LY gained were 65745714 JPY for first-line treatment, 7420202 JPY for third-line or later treatment, and 74750097 JPY and 10496602 JPY per QALY gained, respectively. Probabilistic sensitivity analyses estimated that the probability of NIVO treatment being cost-effective for first-line and third-line treatment was 23.5 and 74.3%, respectively. From the perspective of the Japanese NHI payer, NIVO was cost-effective as third-line or later monotherapy for patients with advanced gastric cancer, but not in combination with first-line chemotherapy.
进行了一项基于模型的成本效果分析，旨在评估不可切除的晚期或复发性胃或胃食管连接部癌患者一线联合化疗与三线或后线单药治疗中纳武利尤单抗（NIVO）的成本效果差异，以支持日本卫生保健的经济评估。总生存期和无进展生存期数据来自 3 期临床试验 ATTRACTION-4 和 ATTRACTION-2。建立了一个分区生存模型来预测成本和结果。从日本国民健康保险（NHI）支付者的角度考虑了直接医疗成本。模型时间范围设定为 10 年。健康结果定义为获得的生命年（LYs）和质量调整生命年（QALYs）。与对照组相比，估计了 NIVO 的增量成本效果比（ICER）。进行了敏感性分析以评估参数设置的不确定性。使用了 1500 万日元（日元）的意愿支付阈值。与每个对照组相比，NIVO 治疗每获得 1 LY 的增量成本效果比分别为一线治疗 65745714 日元、三线或后线治疗 7420202 日元，三线或后线治疗 74750097 日元和 10496602 日元/QALY。概率敏感性分析估计，一线和三线治疗中 NIVO 治疗具有成本效果的概率分别为 23.5%和 74.3%。从日本 NHI 支付者的角度来看，对于晚期胃癌患者，NIVO 作为三线或后线单药治疗具有成本效果，但与一线化疗联合使用则不具有成本效果。
