NATIONAL INDICATION RESTRICTIONS ACROSS EUROPE: DO THEY EXPLAIN CROSS-NATIONAL ACCESS DISPARITIES FOR INNOVATIVE MEDICINES? (2021-2025)
Author(s)
Tea MOYA, PharmD1, Mathis Guffroy, PharmD candidate1, Camille SEGUIER, PharmD1, Elsa Duteil, MSc1, Clément Le Dissez, PharmD1, Daniel Moreira, MSc2, David Reyes, MSc2, Felix Steinbrenner, MSc2.
1PASS, Paris, France, 2Cellbyte, Munich, Germany.
1PASS, Paris, France, 2Cellbyte, Munich, Germany.
OBJECTIVES: To characterize divergences between EMA indication scope and national indication labeling across five European markets and to assess their contribution to observed access disparities.
METHODS: Data were extracted from the Cellbyte® database. EMA-authorized innovative indications approved between April 2021 and April 2026 were compared with national indication labels in France, Germany, Spain, Italy, and the United Kingdom. Each indication was classified as national label more restrictive than EMA, EMA more restrictive than national label, equivalent, or non-comparable. Analyses were conducted on both the full sample and the subset of comparable indications.
RESULTS: Among the 458 identified EMA indications, the proportion of indications considered comparable at the label level varied across countries, ranging from 22% (n=100/458) in Germany to 40% (n=183/458) in Spain; the remaining 60-78% were classified as non-comparable. Within the comparable subset, alignment between national and EMA indication scope was the most frequent outcome across all markets. Spain showed the highest proportion of national labels that were more restrictive than the EMA indication (52%; n=95/183), followed by Italy (27%; n=33/121), France (21%; n=23/108), Germany (19%; n=19/100), and the United Kingdom (10%; n=11/108). Overall, equivalent indication scope remained the predominant pattern among comparable indications across all five countries. Cases where EMA indication scope was more restrictive than national labeling were exceptional and limited to Germany (n=3/100) and the United Kingdom (n=1/108).
CONCLUSIONS: Among comparable indications, national indication labels were aligned with EMA indication scope across the five markets studied. Although national restrictions were identified, particularly in Spain and Italy, their overall contribution to access disparities appeared limited. These findings suggest that differences in national indication scope are unlikely to be the primary driver of observed cross-national access disparities and that reimbursement access and market availability may play a greater role in explaining variation across European markets.
METHODS: Data were extracted from the Cellbyte® database. EMA-authorized innovative indications approved between April 2021 and April 2026 were compared with national indication labels in France, Germany, Spain, Italy, and the United Kingdom. Each indication was classified as national label more restrictive than EMA, EMA more restrictive than national label, equivalent, or non-comparable. Analyses were conducted on both the full sample and the subset of comparable indications.
RESULTS: Among the 458 identified EMA indications, the proportion of indications considered comparable at the label level varied across countries, ranging from 22% (n=100/458) in Germany to 40% (n=183/458) in Spain; the remaining 60-78% were classified as non-comparable. Within the comparable subset, alignment between national and EMA indication scope was the most frequent outcome across all markets. Spain showed the highest proportion of national labels that were more restrictive than the EMA indication (52%; n=95/183), followed by Italy (27%; n=33/121), France (21%; n=23/108), Germany (19%; n=19/100), and the United Kingdom (10%; n=11/108). Overall, equivalent indication scope remained the predominant pattern among comparable indications across all five countries. Cases where EMA indication scope was more restrictive than national labeling were exceptional and limited to Germany (n=3/100) and the United Kingdom (n=1/108).
CONCLUSIONS: Among comparable indications, national indication labels were aligned with EMA indication scope across the five markets studied. Although national restrictions were identified, particularly in Spain and Italy, their overall contribution to access disparities appeared limited. These findings suggest that differences in national indication scope are unlikely to be the primary driver of observed cross-national access disparities and that reimbursement access and market availability may play a greater role in explaining variation across European markets.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HPR33
Topic
Health Policy & Regulatory, Health Technology Assessment, Methodological & Statistical Research
Topic Subcategory
Approval & Labeling, Reimbursement & Access Policy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas