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尼伏单抗单药治疗在英国晚期黑色素瘤患者中的成本效益。

The cost-effectiveness of nivolumab monotherapy for the treatment of advanced melanoma patients in England.

机构信息

BresMed Health Solutions, North Church House, 84 Queen Street, Sheffield, S1 2DW, UK.

Bristol-Myers Squibb Pharmaceuticals, Uxbridge, UK.

出版信息

Eur J Health Econ. 2018 Nov;19(8):1163-1172. doi: 10.1007/s10198-018-0964-4. Epub 2018 Mar 9.

Abstract

BACKGROUND

Nivolumab was the first programmed death receptor 1 (PD-1) immune checkpoint inhibitor to demonstrate long-term survival benefit in a clinical trial setting for advanced melanoma patients.

OBJECTIVE

To evaluate the cost effectiveness of nivolumab monotherapy for the treatment of advanced melanoma patients in England.

METHODS

A Markov state-transition model was developed to estimate the lifetime costs and benefits of nivolumab versus ipilimumab and dacarbazine for BRAF mutation-negative patients and versus ipilimumab, dabrafenib, and vemurafenib for BRAF mutation-positive patients. Covariate-adjusted parametric curves for time to progression, pre-progression survival, and post-progression survival were fitted based on patient-level data from two trials and long-term ipilimumab survival data. Indirect treatment comparisons between nivolumab, ipilimumab, and dacarbazine were informed by these covariate-adjusted parametric curves, controlling for differences in patient characteristics. Kaplan-Meier data from the literature were digitised and used to fit progression-free and overall survival curves for dabrafenib and vemurafenib. Patient utilities and resource use data were based on trial data or the literature. Patients are assumed to receive nivolumab until there is no further clinical benefit, assumed to be the first of progressive disease, unacceptable toxicity, or 2 years of treatment.

RESULTS

Nivolumab is the most cost-effective treatment option in BRAF mutation-negative and mutation-positive patients, with incremental cost-effectiveness ratios of £24,483 and £17,362 per quality-adjusted life year, respectively. The model results are most sensitive to assumptions regarding treatment duration for nivolumab and the parameters of the fitted parametric survival curves.

CONCLUSIONS

Nivolumab is a cost-effective treatment for advanced melanoma patients in England.

摘要

背景

纳武利尤单抗是首个在临床试验中为晚期黑色素瘤患者展示出长期生存获益的程序性死亡受体 1(PD-1)免疫检查点抑制剂。

目的

评估纳武利尤单抗单药治疗英国晚期黑色素瘤患者的成本效果。

方法

开发了一个马尔可夫状态转移模型,以评估纳武利尤单抗与伊匹单抗和达卡巴嗪相比,用于 BRAF 突变阴性患者,以及与伊匹单抗、达拉非尼和维莫非尼相比,用于 BRAF 突变阳性患者的成本效果。根据两项试验的患者水平数据和长期伊匹单抗生存数据,对进展时间、进展前生存和进展后生存的协变量调整参数曲线进行拟合。通过这些协变量调整的参数曲线进行纳武利尤单抗、伊匹单抗和达卡巴嗪之间的间接治疗比较,控制了患者特征的差异。文献中的 Kaplan-Meier 数据被数字化,并用于拟合达拉非尼和维莫非尼的无进展生存和总生存曲线。患者效用和资源使用数据基于试验数据或文献。假设患者接受纳武利尤单抗治疗,直到没有进一步的临床获益,即首次出现疾病进展、无法耐受的毒性或 2 年治疗。

结果

纳武利尤单抗在 BRAF 突变阴性和突变阳性患者中是最具成本效果的治疗选择,增量成本效果比分别为每质量调整生命年 24483 英镑和 17362 英镑。模型结果对纳武利尤单抗治疗持续时间和拟合参数生存曲线的参数的假设最为敏感。

结论

纳武利尤单抗是英国晚期黑色素瘤患者的一种具有成本效果的治疗选择。

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