Reimbursement Trends for Advanced Therapeutic Medicinal Products (ATMPs) in Europe
Author(s)
Mark Chalmers, PhD1, Vidhyasagari Sundaram, MPH2, PRATEEK KANADE, M. Pharm2, Deepti Rai, MPH3, Andrew Browne, MBA4.
1Partner, EY, Dublin, Ireland, 2Ernst & Young, Bangalore, India, 3Ernst & Young, Hyderabad, India, 4Ernst & Young, Dublin, Ireland.
1Partner, EY, Dublin, Ireland, 2Ernst & Young, Bangalore, India, 3Ernst & Young, Hyderabad, India, 4Ernst & Young, Dublin, Ireland.
OBJECTIVES: This study aims to examine the trends in reimbursement and market access for Advanced Therapy Medicinal Products (ATMPs) across Europe (EU4/UK)
METHODS: Data were gathered from the European Medicines Agency (EMA) website to identify all ATMPs (including cell and gene therapies, and tissue-engineered medicines) approved by May 31, 2025, considering the lengthy pricing and reimbursement timelines. Reimbursement information was collected from national Health Technology Assessment (HTA) agency websites.
RESULTS: As of May 2025, 23 ATMPs were approved by the EMA, with 4 withdrawn from the market. Reimbursement rates varied significantly across countries: 79% in France, 74% in Germany, 63% in Italy, 74% in the UK, and only 26% in Spain. Conditional reimbursement was achieved by 16% of ATMPs in Italy and Spain, compared to 26% in the UK. The average time from EMA approval to market access was 562 days in Germany, 711 days in the UK, 860 days in Italy, 1035 days in France, and 1214 days in Spain. Among the 19 ATMPs available in market, only 1 received an ASMR II (Important) rating in France, while 2 received an ASMR II (Moderate) rating. Most were rated ASMR IV (Minor) or ASMR V (Absence). In Germany, 3 ATMPs were recognized for considerable added benefit, while others received non-quantifiable or no added benefit ratings
CONCLUSIONS: The ATMP sector is rapidly evolving within a complex reimbursement landscape that varies by country due to different payer assessment criteria. Access to ATMPs is inconsistent across Europe, with some nations recognizing their value through higher benefit ratings despite criticism from other HTA bodies. Manufacturers must stay informed about reimbursement trends and evolving HTA criteria in order to optimize access outcomes, while payers strive to balance innovation with affordability
METHODS: Data were gathered from the European Medicines Agency (EMA) website to identify all ATMPs (including cell and gene therapies, and tissue-engineered medicines) approved by May 31, 2025, considering the lengthy pricing and reimbursement timelines. Reimbursement information was collected from national Health Technology Assessment (HTA) agency websites.
RESULTS: As of May 2025, 23 ATMPs were approved by the EMA, with 4 withdrawn from the market. Reimbursement rates varied significantly across countries: 79% in France, 74% in Germany, 63% in Italy, 74% in the UK, and only 26% in Spain. Conditional reimbursement was achieved by 16% of ATMPs in Italy and Spain, compared to 26% in the UK. The average time from EMA approval to market access was 562 days in Germany, 711 days in the UK, 860 days in Italy, 1035 days in France, and 1214 days in Spain. Among the 19 ATMPs available in market, only 1 received an ASMR II (Important) rating in France, while 2 received an ASMR II (Moderate) rating. Most were rated ASMR IV (Minor) or ASMR V (Absence). In Germany, 3 ATMPs were recognized for considerable added benefit, while others received non-quantifiable or no added benefit ratings
CONCLUSIONS: The ATMP sector is rapidly evolving within a complex reimbursement landscape that varies by country due to different payer assessment criteria. Access to ATMPs is inconsistent across Europe, with some nations recognizing their value through higher benefit ratings despite criticism from other HTA bodies. Manufacturers must stay informed about reimbursement trends and evolving HTA criteria in order to optimize access outcomes, while payers strive to balance innovation with affordability
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA286
Topic
Health Technology Assessment
Topic Subcategory
Value Frameworks & Dossier Format
Disease
Genetic, Regenerative & Curative Therapies, Personalized & Precision Medicine