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真实环境下抗 CD19 CAR-T 细胞通路治疗大 B 细胞淋巴瘤的经济学评价:意大利枢纽中心开展活动的头三年经验。

Economic evaluation of anti-CD19 CAR T-cell pathway for large B-cell lymphomas in the real-life setting: the experience of an Italian hub center in the first three years of activity.

机构信息

Dipartimento Di Scienze Mediche E Chirurgiche (DIMEC), Università Di Bologna, Via Massarenti, 9-40138, Bologna, Italy.

IRCCS Azienda Ospedaliero-Universitaria Di Bologna, Istituto Di Ematologia "Seràgnoli", Bologna, Italy.

出版信息

Ann Hematol. 2024 Jul;103(7):2499-2509. doi: 10.1007/s00277-024-05766-0. Epub 2024 May 2.

Abstract

Poor literature report actual and detailed costs of chimeric antigen receptor (CAR) T-cell pathway in a real-life setting. We retrospectively collect data for all patients with relapsed/refractory aggressive large B-cell lymphoma who underwent leukapheresis between August 2019 and August 2022. All costs and medical resource consumption accountability were calculated on an intention-to-treat (ITT) basis, starting from leukapheresis to the time when the patient (infused or not) exited the CAR T-cell pathway for any reason. Eighty patients were addressed to leukapheresis and 59 were finally infused. After excluding CAR-T product cost, the main driver of higher costs were hospitalizations followed by the examinations/procedures and other drugs, respectively 43.9%, 26.3% and 25.4% of the total. Regarding costs of drugs and medications other than CAR T products, the most expensive items are those referred to AEs, both infective and extra-infective within 30 days from infusion, that account for 63% of the total. Density plot of cost analyses did not show any statistically significant difference with respect to the years of leukapheresis or infusion. To achieve finally 59/80 infused patients the per capita patients without CAR-T products results 74,000 euros. This analysis covers a growing concern on health systems, the burden of expenses related to CAR T-cell therapy, which appears to provide significant clinical benefit despite its high cost, thus making economic evaluations highly relevant. The relevance of this study should be also viewed in light of continuously evolving indications for this therapy.

摘要

文献对嵌合抗原受体 (CAR) T 细胞途径在真实环境下的实际和详细成本的报告较差。我们回顾性地收集了所有在 2019 年 8 月至 2022 年 8 月期间接受白细胞分离术的复发/难治性侵袭性大 B 细胞淋巴瘤患者的数据。所有成本和医疗资源消耗的责任均基于意向治疗 (ITT) 进行计算,从白细胞分离术开始,直到患者(输注或未输注)因任何原因退出 CAR T 细胞途径的时间。共对 80 例患者进行了白细胞分离术,最终有 59 例患者进行了输注。在排除 CAR-T 产品成本后,更高成本的主要驱动因素是住院治疗,其次是检查/程序和其他药物,分别占总成本的 43.9%、26.3%和 25.4%。关于除 CAR T 产品以外的药物和药物成本,最昂贵的项目是输注后 30 天内与 AE 相关的药物,无论是感染性还是非感染性 AE,占总成本的 63%。成本分析的密度图在白细胞分离术或输注的年份方面没有显示出任何统计学上的显著差异。为了最终实现 59/80 例输注患者,人均无 CAR-T 产品的费用为 74,000 欧元。该分析涵盖了对卫生系统的日益关注,以及与 CAR T 细胞治疗相关的费用负担,尽管成本高昂,但该治疗方法似乎提供了显著的临床获益,因此经济评估具有高度相关性。应根据该疗法的不断发展的适应证来看待本研究的相关性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bc3d/11224113/619d388f1248/277_2024_5766_Fig1_HTML.jpg

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