The EU’s “hospital exemption” rule permits the manufacture and use of CAR-T therapy in academic centers, with member state regulatory oversight. This has been proposed as an alternative to the commercial model for CAR-T development, with global clinical trials and centralized regulatory approval, manufacturing and pharmacovigilance.

Hospital Clinic de Barcelona has been a vocal advocate of the “local” CAR-T model and has demonstrated its viability with ARI-0001 CAR-T for ALL. Spanish authorities have backed the initiative, providing a direct challenge to the high cost of commercial therapies. End-to-end treatment with ARI-001 is reimbursed for a total of €90k in Spain, compared with a list price of c. €300k for commercial CAR-T product.

An ESMO editorial acknowledges the safety and quality disadvantages of the local model and proposes collaboration between industry and academic centers to jointly manufacture CAR-T therapies. This is unlikely to deliver significant cost savings,but might become more relevant with highly personalized therapies.

https://www.annalsofoncology.org/article/S0923-7534(21)04518-X/fulltext