OBJECTIVES: Cell and gene therapies (CGTs) offer curative options for severe diseases at a high financial cost. As more CGTs enter the market, manufacturers and payers must understand the implications of the evolving landscape. This research explored the regulatory and reimbursement landscape of CGTs across France, Germany, Italy, and the UK.

METHODS: Data analytics were conducted based on secondary research outputs to investigate the regulatory and reimbursement landscape of approved CGTs from 1^st January 2015 to 1^st April 2022. Regulatory approvals were extracted from the EMA and MHRA; reimbursement and HTA data were extracted from national HTA agencies.

RESULTS: The first CGT was launched in 2015, and the annual number of regulatory approvals has increased over time; 12 CGTs were approved by EMA and 11 by MHRA by 1st April 2022. Currently, over 80% of approved CGTs target orphan (42% [EMA]; 45% [MHRA]) or oncology (42% [EMA]; 36% [MHRA]) indications. The number of reimbursed CGTs has increased since 2015; at time of research, 8 were reimbursed in France and Germany, 7 in Italy, and 10 in the UK. Between 2018 and 2021, the number of reimbursed CGTs increased by 300% in Germany, whilst in Italy, the number of reimbursed CGTs increased by 20%. The average time to reimbursement of CGTs with published data was the highest in Italy (14 months), followed by Germany (10 months), the UK (8 months), and France (6 months).

CONCLUSIONS: The CGT landscape across Europe is evolving, with a growing priority to improve access to therapies in areas with unmet needs. Access schemes and conditional agreements, such as the CDF in the UK and ATU in France, provide opportunities to improve time to access.