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真实世界中大 B 细胞淋巴瘤抗 CD19 CAR-T 细胞治疗路径的经济学评价:一家意大利枢纽中心运行前三年的经验

英文原题: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.

查看英文原题

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.

PubMed 2024/05/02(内容时间) Ann Hematol Q3 · IF 2.3(JCR 2025)

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中文摘要

文献中关于现实世界嵌合抗原受体(CAR)T 细胞治疗流程实际成本和详细支出的报告较少。本研究回顾收集 2019 年 8 月至 2022 年 8 月接受白细胞单采的复发/难治性侵袭性大 B 细胞淋巴瘤患者数据。所有成本和医疗资源消耗均按意向治疗(ITT)原则核算,从白细胞单采开始,直至患者(无论是否接受输注)因任何原因退出 CAR-T 治疗流程。80 例患者接受白细胞单采,最终 59 例接受输注。不计 CAR-T 产品成本,成本的主要驱动因素为住院,其次为检查/操作和其他药物,分别占总成本的 43.9%、26.3% 和 25.4%。在 CAR-T 产品以外的药物和用药成本中,最昂贵项目是输注后 30 天内与不良事件(感染性或非感染性)相关的用药,占总药物成本的 63%。成本分析密度图未显示白细胞单采或输注年份之间存在统计学显著差异。若要使 80 例单采患者中最终 59 例接受 CAR-T 输注,不含 CAR-T 产品的患者人均成本为 74,000 欧元。本分析回应了医疗卫生系统日益关注的问题:CAR-T 治疗支出负担沉重,尽管其可带来显著临床获益,但经济学评估十分重要。随着 CAR-T 适应证不断演变,本研究也具有重要参考价值。

展开英文摘要原文

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.

论文信息

作者
Di Staso R、Casadei B、Gentilini M、Guadagnuolo S、Pellegrini C、Broccoli A、Gori D、Masetti R
第一作者单位
Dipartimento Di Scienze Mediche E Chirurgiche (DIMEC), Università Di Bologna, Via Massarenti, 9-40138, Bologna, Italy.Italy
通讯作者单位
Dipartimento Di Scienze Mediche E Chirurgiche (DIMEC), Università Di Bologna, Via Massarenti, 9-40138, Bologna, Italy. lisa.argnani@unibo.it.Italy
期刊
Annals of hematology2024 Jul
原文标识
PubMed 38695872 · DOI 10.1007/s00277-024-05766-0