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无法切除的 III 期非小细胞肺癌放化疗后度伐利尤单抗的成本效益:美国医疗保健视角。

Cost-Effectiveness of Durvalumab After Chemoradiotherapy in Unresectable Stage III NSCLC: A US Healthcare Perspective.

机构信息

1University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center, Baltimore, Maryland.

2AstraZeneca Pharmaceuticals LP, Gaithersburg, Maryland.

出版信息

J Natl Compr Canc Netw. 2021 Feb 2;19(2):153-162. doi: 10.6004/jnccn.2020.7621. Print 2021 Feb.

Abstract

BACKGROUND

Durvalumab was approved by the FDA in February 2018 for patients with unresectable stage III NSCLC that has not progressed after platinum-based concurrent chemoradiotherapy (cCRT), and this regimen is the current standard of care. The objective of this study was to examine the cost-effectiveness of durvalumab following cCRT versus cCRT alone in patients with locally advanced, unresectable stage III NSCLC.

METHODS

A 3-state semi-Markov model was used. Modeling was performed in a US healthcare setting from Medicare and commercial payer perspectives over a 30-year time horizon. Clinical efficacy (progression-free and post progression survival) and utility inputs were based on PACIFIC study data (ClinicalTrials.gov identifier: NCT02125461; data cutoff March 22, 2018). Overall survival extrapolation was validated using overall survival data from a later data cutoff (January 31, 2019). The main outcome was the incremental cost-effectiveness ratio (ICER) of durvalumab following cCRT versus cCRT alone, calculated as the difference in total costs between treatment strategies per quality-adjusted life-year (QALY) gained.

RESULTS

In the base-case analysis, durvalumab following cCRT was cost-effective versus cCRT alone from Medicare and commercial insurance perspectives, with ICERs of $55,285 and $61,111, respectively, per QALY gained. Durvalumab was thus considered cost-effective at the $100,000 willingness-to-pay (WTP) threshold. Sensitivity analyses revealed the model was particularly affected by variables associated with subsequent treatment, although no tested variable increased the ICER above the WTP threshold. Scenario analyses showed the model was most sensitive to assumptions regarding time horizon, treatment effect duration, choice of fitted progression-free survival curve, subsequent immunotherapy treatment duration, and use of a partitioned survival model structure.

CONCLUSIONS

In a US healthcare setting, durvalumab was cost-effective compared with cCRT alone, further supporting the adoption of durvalumab following cCRT as the new standard of care in patients with unresectable stage III NSCLC.

摘要

背景

2018 年 2 月,FDA 批准 durvalumab 用于铂类同期放化疗(cCRT)后未进展的不可切除 III 期非小细胞肺癌(NSCLC)患者,该方案是目前的标准治疗方法。本研究旨在评估 durvalumab 联合 cCRT 与单纯 cCRT 相比在局部晚期、不可切除 III 期 NSCLC 患者中的成本效益。

方法

采用三状态半马尔可夫模型。建模在美国医疗保健环境中进行,从医疗保险和商业支付者的角度,在 30 年的时间范围内进行。临床疗效(无进展和进展后生存)和效用输入基于 PACIFIC 研究数据(ClinicalTrials.gov 标识符:NCT02125461;数据截止日期 2018 年 3 月 22 日)。使用后期数据截止日期(2019 年 1 月 31 日)的总生存数据验证总生存外推。主要结果是 durvalumab 联合 cCRT 与单纯 cCRT 相比的增量成本效益比(ICER),以每获得一个质量调整生命年(QALY)的总成本差异计算。

结果

在基础病例分析中,从医疗保险和商业保险的角度来看,durvalumab 联合 cCRT 比单纯 cCRT 更具成本效益,ICER 分别为 55285 美元和 61111 美元/QALY。因此,durvalumab 在 10 万美元的意愿支付(WTP)阈值下是具有成本效益的。敏感性分析表明,该模型特别受到与后续治疗相关的变量的影响,尽管没有测试变量使 ICER 超过 WTP 阈值。情景分析表明,该模型对时间范围、治疗效果持续时间、拟合无进展生存曲线的选择、后续免疫治疗持续时间以及使用分区生存模型结构的假设最为敏感。

结论

在美国医疗保健环境中,durvalumab 与单纯 cCRT 相比具有成本效益,进一步支持在不可切除 III 期 NSCLC 患者中采用 durvalumab 联合 cCRT 作为新标准治疗。

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