Comparative analysis of CAR T-cell therapy access for DLBCL patients: associated challenges and solutions in the four largest EU countries

Frontiers in Medicine

Medicine

Guillaume Cartron¹  Armando Santoro²  Eva M. Wagner-Drouet³  Miguel Á. Canales Albendea⁴  Reinhard Marks⁵  Pier Luigi Canonico⁶  Claudio Jommi⁶  Catherine Rioufol⁷  Barthold Deiters⁸  Juan M. Sancho Cia⁹ 

[1] Centre Hospitalier Universitaire de Montpellier, UMR-CNRS 5535, Montpellier, France;Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy;IRCCS Humanitas Research Hospital, Humanitas Cancer Center, Milan, Italy;Department of Hematology and Oncology, University Medical Center, Mainz, Germany;Department of Hematology, Clínica Universidad de Navarra, Pamplona, Spain;Department of Medicine I, Medical Center, University of Freiburg, Freiburg, Germany;Department of Pharmaceutical Sciences, Università del Piemonte Orientale, Novara, Italy;Department of Pharmacy, Lyon Sud Hospital, Hospices Civils de Lyon, Lyon, France;EA 3738 Center for Innovation in Cancerology of Lyon (CICLY)-Claude Bernard University Lyon I, Lyon, France;GWQ ServicePlus AG, Düsseldorf, Germany;ICO-IJC-Hospital Germans Trias i Pujol, Badalona, Spain;

关键词: CAR T-cell therapy;    diffuse large B-cell lymphoma;    patient access;    health system;    Germany;    France;    Italy;    Spain;   

DOI  :  10.3389/fmed.2023.1128295

 received in 2022-12-20, accepted in 2023-04-25,  发布年份 2023

来源: Frontiers

【 摘 要 】

IntroductionCAR T-cell therapy has emerged as a promising new immuno-oncology treatment that engages the patient’s immune system to fight certain hematological malignancies, including diffuse large B-cell lymphoma (DLBCL). In the European Union (EU), CAR T-cell therapies have been approved for relapsed/refractory (R/R) DLBCL patients since 2018, but patient access is often still limited or delayed. This paper is aimed at discussing challenges to access and possible solutions in the largest four EU countries.MethodsThe analysis relied on literature review, market data collection, since homogeneous data coming from registries were not available, and discussion with experts coming from all four countries.ResultsWe calculated that in 2020, between 58% and 83% of R/R DLBCL patients (EMA approved label population) or between 29% and 71% of the estimated medically eligible R/R DLBCL patients, were not treated with a licensed CAR T-cell therapy. Common challenges along the patient journey that may result in limited access or delays to CAR T-cell therapy were identified. These include timely identification and referral of eligible patients, pre-treatment funding approval by authorities and payers, and resource needs at CAR T-cell centers.DiscussionThese challenges, existing best practices and recommended focus areas for health systems are discussed here, with the aim to inform necessary actions for overcoming patient access challenges for current CAR T-cell therapies as well as for future cell and gene therapies.

【 授权许可】

Unknown   
Copyright © 2023 Canales Albendea, Canonico, Cartron, Deiters, Jommi, Marks, Rioufol, Sancho Cia, Santoro and Wagner-Drouet.