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日本晚期非小细胞肺癌一线纳武利尤单抗联合伊匹木单抗治疗的成本效果分析。

Cost-Effectiveness of First-Line Nivolumab Plus Ipilimumab Combination Therapy in Advanced Non-Small-Cell Lung Cancer in Japan.

机构信息

Comprehensive Unit for Health Economic Evidence Review and Decision Support (CHEERS), Research Organization of Science and Technology, Ritsumeikan University, #215, Kyoto Research Park Bld. No. 6, 93 Awata-machi, Chudoji, Shimogyo-ku, Kyoto, 600-8815, Japan.

Comprehensive Unit for Health Economic Evidence Review and Decision Support (CHEERS), Research Organization of Science and Technology, Ritsumeikan University, #209, Research Park Bid. No.2, 134, Minamimachi, Chudoji, Simogyo-ku, Kyoto, 600-8813, Japan.

出版信息

Clin Drug Investig. 2022 Jul;42(7):599-609. doi: 10.1007/s40261-022-01168-0. Epub 2022 Jun 8.

Abstract

BACKGROUND AND OBJECTIVE

In Japan, indications for nivolumab have been expanded to include the combination therapy with ipilimumab in various cancers. This study aimed to evaluate the cost-effectiveness of combination therapy of nivolumab plus ipilimumab (NIV + IPI) for patients with advanced non-small-cell lung cancer (NSCLC), comparing it with platinum-doublet chemotherapy in Japanese settings.

METHODS

A partitioned survival model was developed to predict costs and quality-adjusted life-years (QALYs) in a NIV + IPI arm and a chemotherapy arm. Data on overall survival and progression-free survival were derived from the CheckMate 227 trial. Cost estimates were based on a Japanese healthcare system perspective using real-world data from the JMDC claims database. Utilities were derived from published sources outside Japan. The incremental cost-effectiveness ratio (ICER) of NIV + IPI therapy compared with chemotherapy was estimated. A scenario analysis on the level of programmed death-ligand 1 (PD-L1) expression was conducted. In addition, sensitivity analyses were performed to assess the uncertainty in parameter settings.

RESULTS

Compared with chemotherapy, NIV + IPI therapy incurred an additional cost of USD102,623 and conferred an additional 1.007 QALY, which resulted in an ICER of USD101,950/QALY gained. Contrary to prior expectations, the ICER of patients with a PD-L1 expression level ≥ 1% was higher than that of patients with a PD-L1 expression level < 1% (USD145,868/QALY and USD127,737/QALY, respectively). Sensitivity analyses showed a relatively robust result with the ICERs remaining higher than a Japanese price adjustment threshold of USD75,000/QALY with a few exceptions.

CONCLUSIONS

The combination of NIV + IPI as first-line therapy would not be cost effective under a willingness-to-pay threshold of USD75,000/QALY from the perspective of the Japanese healthcare system.

摘要

背景和目的

在日本,纳武利尤单抗的适应证已扩大到包括与伊匹单抗联合用于各种癌症。本研究旨在评估纳武利尤单抗联合伊匹单抗(NIV+IPI)联合疗法用于晚期非小细胞肺癌(NSCLC)患者的成本效果,与日本环境下的铂类双联化疗进行比较。

方法

采用分割生存模型预测 NIV+IPI 组和化疗组的成本和质量调整生命年(QALY)。总生存和无进展生存数据来源于 CheckMate 227 试验。成本估算基于 JMDC 索赔数据库中的真实世界数据,从日本医疗保健系统的角度出发。效用值来源于日本以外的已发表资料。对 NIV+IPI 治疗与化疗相比的增量成本效果比(ICER)进行了估计。对程序性死亡配体 1(PD-L1)表达水平进行了情景分析。此外,还进行了敏感性分析,以评估参数设置的不确定性。

结果

与化疗相比,NIV+IPI 治疗增加了 102623 美元的额外成本,并带来了 1.007 个 QALY,导致 ICER 为 101950 美元/QALY。与之前的预期相反,PD-L1 表达水平≥1%的患者的 ICER 高于 PD-L1 表达水平<1%的患者(分别为 145868 美元/QALY 和 127737 美元/QALY)。敏感性分析显示,除少数例外,在日本 75000 美元/QALY 的价格调整阈值下,ICER 仍然较高,结果相对稳健。

结论

从日本医疗保健系统的角度来看,在愿意支付 75000 美元/QALY 的阈值下,纳武利尤单抗联合伊匹单抗作为一线治疗的方案不具有成本效果。

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