FROM EMA AUTHORIZATION TO REIMBURSEMENT ACCESS: A CROSS-NATIONAL ANALYSIS OF MARKET ACCESS GAPS ACROSS FIVE EUROPEAN MARKETS (2021-2026)
Author(s)
Camille SEGUIER, PharmD1, Tea MOYA, MSc1, Mathis Guffroy, PharmD candidate1, Elsa Duteil, MSc1, Clément Le Dissez, MSc1, Daniel Moreira, MSc2, David Reyes, MSc2, Felix Steinbrenner, MSc2.
1PASS, Paris, France, 2Cellbyte, Munich, Germany.
1PASS, Paris, France, 2Cellbyte, Munich, Germany.
OBJECTIVES: To assess the extent to which EMA-authorized innovative indications achieved reimbursement access across five major European markets and to evaluate cross-national overlap among reimbursed and unreimbursed indications.
METHODS: Data were extracted from the Cellbyte® database. EMA-authorized innovative indications approved between April 2021 and April 2026 were assessed for reimbursement access, defined as the presence of both an HTA evaluation and a published price, across France, Germany, Spain, Italy, and the United Kingdom. Cross-national overlap was analyzed separately among reimbursed and unreimbursed indications using France as the reference market.
RESULTS: Among 458 identified indications, no country achieved reimbursement access for more than 50% of EMA-authorized indications; Germany showed the highest rate (43%, n=199/458), followed by Spain (40%, n=183/458), Italy (27%, n=123/458), and France and the United Kingdom (both 24%, n=108/458 and n=109/458, respectively). Cross-national overlap revealed a clear contrast between reimbursed and unreimbursed indications: among the 108 reimbursed indications in France, 80% (n=86/108) were also reimbursed in Germany, 78% (n=80/108) in Spain, 59% (n=64/108) in Italy, and 48% (n=52/108) in the United Kingdom. Conversely, among the 76% (n=350/458) unreimbursed indications in France, only 32% (n=113/350) were reimbursed in Germany, 28% (n=99/350) in Spain, 17% (n=59/350) in Italy, and 16% (n=57/350) in the United Kingdom. Overall, 38% (n=175/458) of EMA indications remained unreimbursed in all five markets; 19% (n=89/458) had neither an HTA evaluation nor a published price in any studied market.
CONCLUSIONS: EMA authorization alone does not ensure reimbursement access, with fewer than half of authorized indications achieving reimbursement access in any studied market. Substantial cross-national overlap was observed among reimbursed indications, whereas unreimbursed indications were largely absent across all studied markets. These findings suggest that observed cross-national differences may reflect variation in market access progression and reimbursement timing rather than fundamentally different reimbursement outcomes.
METHODS: Data were extracted from the Cellbyte® database. EMA-authorized innovative indications approved between April 2021 and April 2026 were assessed for reimbursement access, defined as the presence of both an HTA evaluation and a published price, across France, Germany, Spain, Italy, and the United Kingdom. Cross-national overlap was analyzed separately among reimbursed and unreimbursed indications using France as the reference market.
RESULTS: Among 458 identified indications, no country achieved reimbursement access for more than 50% of EMA-authorized indications; Germany showed the highest rate (43%, n=199/458), followed by Spain (40%, n=183/458), Italy (27%, n=123/458), and France and the United Kingdom (both 24%, n=108/458 and n=109/458, respectively). Cross-national overlap revealed a clear contrast between reimbursed and unreimbursed indications: among the 108 reimbursed indications in France, 80% (n=86/108) were also reimbursed in Germany, 78% (n=80/108) in Spain, 59% (n=64/108) in Italy, and 48% (n=52/108) in the United Kingdom. Conversely, among the 76% (n=350/458) unreimbursed indications in France, only 32% (n=113/350) were reimbursed in Germany, 28% (n=99/350) in Spain, 17% (n=59/350) in Italy, and 16% (n=57/350) in the United Kingdom. Overall, 38% (n=175/458) of EMA indications remained unreimbursed in all five markets; 19% (n=89/458) had neither an HTA evaluation nor a published price in any studied market.
CONCLUSIONS: EMA authorization alone does not ensure reimbursement access, with fewer than half of authorized indications achieving reimbursement access in any studied market. Substantial cross-national overlap was observed among reimbursed indications, whereas unreimbursed indications were largely absent across all studied markets. These findings suggest that observed cross-national differences may reflect variation in market access progression and reimbursement timing rather than fundamentally different reimbursement outcomes.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HPR253
Topic
Health Policy & Regulatory, Methodological & Statistical Research
Topic Subcategory
Approval & Labeling, Reimbursement & Access Policy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas