Suppr超能文献

基于真实世界法国登记数据的阿基仑赛与Tisagenlecleucel 治疗弥漫性大 B 细胞淋巴瘤的成本-效果分析。

A Cost-Effectiveness Analysis of Axicabtagene Ciloleucel versus Tisagenlecleucel in the Treatment of Diffuse Large B-cell Lymphoma Based on a Real-World French Registry.

机构信息

Kite, a Gilead Company, Santa Monica, USA.

Kite, a Gilead Company, London, UK.

出版信息

Adv Ther. 2024 Nov;41(11):4282-4298. doi: 10.1007/s12325-024-02971-1. Epub 2024 Sep 24.

Abstract

INTRODUCTION

Axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tisa-cel) are chimeric antigen receptor T-cell therapies that were evaluated in third and later line (3L+) relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) in the ZUMA-1 and JULIET trials, respectively. As of October 2021, the DESCAR-T registry included 729 French patients with 3L+ r/r DLBCL who received axi-cel or tisa-cel. Using these data, propensity score matching was used to conduct an adjusted comparison between axi-cel and tisa-cel. Axi-cel was associated with statistically significant improvements in overall survival (OS) and progression-free survival (PFS), and significantly more frequent Grade ≥ 3 immune effector cell-associated neurotoxicity syndrome (ICANS), compared with tisa-cel. There was no significant difference in Grade ≥ 3 cytokine release syndrome (CRS). The current analysis assessed the cost-effectiveness of axi-cel versus tisa-cel in the treatment of 3L+ r/r DLBCL using propensity score-matched data from the DESCAR-T registry.

METHODS

A partitioned survival model was used to extrapolate costs and quality-adjusted life years (QALYs) over a lifetime. Survival curves for PFS and OS were based on independent mixture cure models fitted to digitized Kaplan-Meier data for the propensity score-matched DESCAR-T populations. Average duration of intensive care unit stays for each of axi-cel and tisa-cel in DESCAR-T were used to inform adverse event costs. Selected parametric survival distributions were based on clinical expert validation. Utility values were derived from ZUMA-1, and costs were obtained from French registries and published sources. List prices were used for both axi-cel and tisa-cel. Costs and outcomes were discounted at an annual rate of 2.5%.

RESULTS

Axi-cel is associated with an incremental cost-effectiveness ratio of €15,520 per QALY compared with tisa-cel.

CONCLUSION

Based on explicit willingness-to-pay thresholds applied in Europe, axi-cel is expected to be a cost-effective use of healthcare resources in real-world clinical settings compared with tisa-cel in 3L+ r/r DLBCL.

摘要

简介

Axicabtagene ciloleucel(axi-cel)和 tisagenlecleucel(tisa-cel)是嵌合抗原受体 T 细胞疗法,分别在 ZUMA-1 和 JULIET 试验中评估了用于三线及以上(3L+)复发或难治性(r/r)弥漫性大 B 细胞淋巴瘤(DLBCL)的疗效。截至 2021 年 10 月,DESCAR-T 登记处包括 729 名法国 3L+r/r DLBCL 患者,他们接受了 axi-cel 或 tisa-cel 治疗。使用这些数据,通过倾向评分匹配,对 axi-cel 和 tisa-cel 进行了调整后的比较。与 tisa-cel 相比,axi-cel 在总生存期(OS)和无进展生存期(PFS)方面具有统计学意义的改善,并且更频繁地发生≥3 级免疫效应细胞相关神经毒性综合征(ICANS)。两组之间≥3 级细胞因子释放综合征(CRS)无显著差异。本分析使用 DESCAR-T 登记处的倾向评分匹配数据,评估了 axi-cel 与 tisa-cel 在治疗 3L+r/r DLBCL 中的成本效益。

方法

使用分区生存模型来推断终生的成本和质量调整生命年(QALYs)。基于独立混合治愈模型的 PFS 和 OS 生存曲线适用于 DESCAR-T 人群的数字化 Kaplan-Meier 数据。DESCAR-T 中 axi-cel 和 tisa-cel 的平均重症监护病房停留时间用于告知不良事件成本。选择参数生存分布基于临床专家验证。效用值来自 ZUMA-1,成本来自法国登记处和已发表的来源。使用列表价格分别为 axi-cel 和 tisa-cel。成本和结果按每年 2.5%贴现。

结果

与 tisa-cel 相比,axi-cel 的增量成本效益比为每 QALY 15520 欧元。

结论

根据在欧洲应用的明确意愿支付阈值,与 tisa-cel 相比,axi-cel 有望在 3L+r/r DLBCL 的真实临床环境中成为一种具有成本效益的医疗资源利用方式。

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型,支持多种主流文档格式。

立即体验