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. 2023 May 30:10:1128295.
doi: 10.3389/fmed.2023.1128295. eCollection 2023.

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

Miguel Á Canales Albendea  1 , Pier Luigi Canonico  2 , Guillaume Cartron  3 , Barthold Deiters  4 , Claudio Jommi  2 , Reinhard Marks  5 , Catherine Rioufol  6   7 , Juan M Sancho Cia  8 , Armando Santoro  9   10 , Eva M Wagner-Drouet  11
Affiliations

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

Miguel Á Canales Albendea et al. Front Med (Lausanne). .

Abstract

Introduction: CAR 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.

Methods: The 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.

Results: We 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.

Discussion: These 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.

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

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
2020 DLBCL CAR T-cell therapy access analysis in Germany, France, Italy, and Spain. Numbers in graph indicate total patient numbers in the EU-4 countries. Bar graph height represents patient numbers normalized per 1 million inhabitants (relative to country population size in 2020). R/R – relapsed/refractory.
See this image and copyright information in PMC

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