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纳武利尤单抗一线与二线治疗日本晚期食管癌的成本效果比较。

Comparative cost-effectiveness of nivolumab first-line and second-line therapy for advanced esophageal cancer in Japan.

机构信息

Department of Clinical Pharmacy and Healthcare Science, Faculty of Pharmacy, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kakuma-Machi, Kanazawa, 920-1192, Japan.

出版信息

Eur J Health Econ. 2024 Apr;25(3):459-470. doi: 10.1007/s10198-023-01602-w. Epub 2023 Jun 1.

Abstract

OBJECTIVE

A model-based cost-effectiveness analysis comparing first-line and second-line nivolumab therapy for advanced esophageal cancer was performed to support public healthcare in Japan.

METHODS

A partitioned survival model was developed to predict costs and outcomes. Survival data were obtained from two phase 3 clinical trials (Attraction-3 and Checkmate-648), and direct medical costs were estimated from the perspective of the Japanese National Health Insurance payer. The time horizon for the model was set to 20 years. Health outcomes were calculated and defined as quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICER) were compared to those of control therapy. A sensitivity analysis was performed based on parameter settings and model uncertainties. A willingness-to-pay threshold of 15 million Japanese yen (JPY) was established.

RESULTS

Compared to that of each control therapy, the ICER for nivolumab per QALY gained was 15,712,265 JPY (143,099 USD) for first-line combination therapy with chemotherapy in the overall population, 10,657,085 JPY (97,059 USD) in the population with ≥ 1% Programmed Death-Ligand 1 (PD-L1) expression, and 41,184,322 JPY (375,085 USD) for second-line nivolumab monotherapy. A probabilistic sensitivity analysis estimated that nivolumab was cost-effective as a first-line therapy for the overall population (61.5%) and for the population with ≥ 1% PD-L1 expression (76.5%), but not as second-line monotherapy (32.3%).

CONCLUSION

Nivolumab is recommended as a first-line therapy in combination with chemotherapy owing to its cost-effectiveness, but not as a second-line monotherapy. Patient selection based on PD-L1 expression may help to improve the cost-effectiveness of using nivolumab as a first-line treatment.

摘要

目的

本项基于模型的成本效果分析旨在比较纳武利尤单抗一线和二线治疗晚期食管癌的效果,以为日本公共医疗保健提供支持。

方法

构建了一个分割生存模型以预测成本和结局。生存数据来自两项 3 期临床试验(ATTRACTION-3 和 CHECKMATE-648),直接医疗成本则从日本国家健康保险支付者的角度进行了估算。模型时间范围设定为 20 年。健康结果以质量调整生命年(QALY)进行计算,并将增量成本效果比(ICER)与对照治疗进行比较。基于参数设定和模型不确定性进行了敏感性分析。设定了 1.5712 亿日元(JPY)的意愿支付阈值。

结果

与每种对照治疗相比,对于总体人群中的纳武利尤单抗联合化疗一线治疗,纳武利尤单抗每获得一个 QALY 的增量成本效果比为 15712255 日元(143099 美元),对于 PD-L1 表达≥1%的人群为 10657085 日元(97059 美元),对于二线纳武利尤单抗单药治疗为 41184322 日元(375085 美元)。概率敏感性分析估计,纳武利尤单抗作为一线治疗对于总体人群(61.5%)和 PD-L1 表达≥1%的人群(76.5%)具有成本效果,但对于二线单药治疗则不具有成本效果(32.3%)。

结论

由于其成本效果,纳武利尤单抗联合化疗被推荐作为一线治疗选择,但不推荐作为二线单药治疗。基于 PD-L1 表达的患者选择可能有助于提高纳武利尤单抗作为一线治疗的成本效果。

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