CAR T-Cell Therapies in Italy: Patient Access Barriers and Recommendations for Health System Solutions

Claudio Jommi; Stefania Bramanti; Marcello Pani; Alessandro Ghirardini; Armando Santoro

doi:10.3389/fphar.2022.915342

CAR T-Cell Therapies in Italy: Patient Access Barriers and Recommendations for Health System Solutions

Front Pharmacol. 2022 Jun 23:13:915342. doi: 10.3389/fphar.2022.915342. eCollection 2022.

Authors

Claudio Jommi¹, Stefania Bramanti², Marcello Pani³, Alessandro Ghirardini^{4

5}, Armando Santoro^{2

6}

Affiliations

¹ CERGAS (Centre for Research on Health and Social Care Management), SDA Bocconi School of Management), Bocconi University, Milan, Italy.
² IRCCS Humanitas Research Hospital- Humanitas Cancer Center, Rozzano, Italy.
³ Agostino Gemelli University Policlinic, Rome, Italy.
⁴ Istituto Superiore di Sanità, Rome, Italy.
⁵ National Center for Telemedicine and New Assistive Technologies, National Institute of Health, Rome, Italy.
⁶ Humanitas University Pieve Emanuele, Milan, Italy.

Abstract

CAR T-cell therapy has emerged as a potentially transformative immunotherapy for certain B-cell malignancies including relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Unhindered and appropriate access for eligible patients is essential to enable optimal outcomes and depends on effective interplay of stakeholders and processes along the patient's therapeutic journey. In Italy, CAR T-cell therapies have been awarded innovation status by the Italian Medicines Agency (AIFA) and were integrated into routine patient care under specific criteria. However, our analysis indicates that fewer than one in five DLBCL patients eligible under the EMA authorization, or around one in three DLBCL patients eligible under the AIFA criteria, received treatment with a licensed CAR T-cell therapy product in 2020. This publication describes key patient access barriers to CAR T-cell therapies in Italy and provides recommendations on potential solutions at the health system level.

Keywords: CAR T-cell therapy; DLBCL; Italy; health policy; health system governance; patient access.