FROM EMA AUTHORIZATION TO REIMBURSEMENT ACCESS IN FRANCE: TEMPORAL TRENDS AND MARKET ACCESS PROGRESSION AMONG INNOVATIVE INDICATIONS (2021-2026)
Author(s)
Mathis Guffroy, PharmD1, Tea MOYA, PharmD1, 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: This study aimed to assess the rate and temporal evolution of effective access in France for EMA-authorized innovative indications and to characterize the market access status of non-accessible indications.
METHODS: Data were extracted from the Cellbyte® database. All EMA-authorized innovative indications approved between April 2021 and April 2026 were assessed for effective access in France, defined as the presence of both an HTA evaluation and a published price. Non-accessible indications were further characterized according to HTA assessment and pricing status across annual cohorts to identify at which stage of the reimbursement process had not been achieved.
RESULTS: Of 458 EMA-authorized indications, only 24% (n=108/458) met the effective access definition in France. Among the 350 non-accessible indications, 83% (n=291/350) had neither an HTA evaluation nor a published price, while 17% (n=59/350) had a published price only. The effective access rate declined across successive approval cohorts, from 43% (n=29/68) among indications authorized in 2021 to 34% (n=35/104) in 2022, 31% (n=23/74) in 2023, 15% (n=16/107) in 2024, and 6% (n=5/82) in 2025 ; no indication authorized in 2026 had yet achieved effective access. Among the 350 non-accessible indications, 83% (n=291/350) had neither an HTA evaluation nor a published price. The remaining 17% (n=59/350) had a published price, but no corresponding HTA evaluation was identified in the database.
CONCLUSIONS: In France, only one quarter of EMA authorization had achieved effective access to reimbursement access. Most non-accessible indications lacked both an HTA evaluation and a published price, suggesting limited progression through key market access milestones. The marked decline observed among recent approval cohorts appears consistent with the time required to complete HTA and pricing procedures. The observed patterns may indicate that access gaps are more frequently associated with delayed market access progression than with negative reimbursement decisions.
METHODS: Data were extracted from the Cellbyte® database. All EMA-authorized innovative indications approved between April 2021 and April 2026 were assessed for effective access in France, defined as the presence of both an HTA evaluation and a published price. Non-accessible indications were further characterized according to HTA assessment and pricing status across annual cohorts to identify at which stage of the reimbursement process had not been achieved.
RESULTS: Of 458 EMA-authorized indications, only 24% (n=108/458) met the effective access definition in France. Among the 350 non-accessible indications, 83% (n=291/350) had neither an HTA evaluation nor a published price, while 17% (n=59/350) had a published price only. The effective access rate declined across successive approval cohorts, from 43% (n=29/68) among indications authorized in 2021 to 34% (n=35/104) in 2022, 31% (n=23/74) in 2023, 15% (n=16/107) in 2024, and 6% (n=5/82) in 2025 ; no indication authorized in 2026 had yet achieved effective access. Among the 350 non-accessible indications, 83% (n=291/350) had neither an HTA evaluation nor a published price. The remaining 17% (n=59/350) had a published price, but no corresponding HTA evaluation was identified in the database.
CONCLUSIONS: In France, only one quarter of EMA authorization had achieved effective access to reimbursement access. Most non-accessible indications lacked both an HTA evaluation and a published price, suggesting limited progression through key market access milestones. The marked decline observed among recent approval cohorts appears consistent with the time required to complete HTA and pricing procedures. The observed patterns may indicate that access gaps are more frequently associated with delayed market access progression than with negative reimbursement decisions.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HPR210
Topic
Economic Evaluation, Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Approval & Labeling, Health Disparities & Equity, Reimbursement & Access Policy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas