Bridging the Gap: How Early Access Shapes Pricing and Reimbursed Populations in France
Author(s)
Isobel Owens-Smith1, Isaac Pena, BSc2, Sabina Juarez, BSc2.
1Red Nucleus, London, United Kingdom, 2Red Nucleus, Yardley, PA, USA.
1Red Nucleus, London, United Kingdom, 2Red Nucleus, Yardley, PA, USA.
OBJECTIVES: France’s early access programmes (AAPs; ATU, AP1, AP2) allow patient access to innovative therapies prior to marketing authorisation and health technology assessment (HTA). AAPs are often the first market access hurdle in Europe but their influence on final pricing and access is not formally defined. This analysis evaluates differences in indications and pricing between AAP and formal reimbursement in France.
METHODS: Therapies granted early access (AP1/AP2) and subsequently reimbursed in France between 2022 and 2025 were identified using the Haute Autorité de Santé (HAS) and the Ministère du Travail, de la Santé, des Solidarités et des Familles databases. Products were limited to first indication launches, were required to have completed AP1/AP2 and been reimbursed. AAP list prices and indications were sourced from the ANSM website. Launch list prices and indications and time to reimbursement were sourced from GlobalData. Products were categorised by therapeutic area, and differences in population scope and pricing between early access and launch were assessed.
RESULTS: Among 17 therapies granted early access, 5 were reimbursed with publicly available data showing differences between AAP and launch populations. The mean AAP price was 9% lower than the mean launch price (€41,458 versus €45,735). List prices remained unchanged for 24% (n=4) of the products, increased for 29% (n=5) and decreased for 46% (n=8). The time from AAP start to reimbursement ranged from 49 to 365 days and 50% of therapies were for oncology indication, 38% orphan diseases and 12% infectious diseases.
CONCLUSIONS: French early access programmes typically limit use to narrower, high-need populations. Most therapies launched with the same indication and little to no price change, demonstrating the importance for manufacturers to consider European pricing strategies early in the access pathway. These patterns offer important insights for manufacturers planning launch and pricing strategies, particularly in high-priority areas like oncology and orphan diseases.
METHODS: Therapies granted early access (AP1/AP2) and subsequently reimbursed in France between 2022 and 2025 were identified using the Haute Autorité de Santé (HAS) and the Ministère du Travail, de la Santé, des Solidarités et des Familles databases. Products were limited to first indication launches, were required to have completed AP1/AP2 and been reimbursed. AAP list prices and indications were sourced from the ANSM website. Launch list prices and indications and time to reimbursement were sourced from GlobalData. Products were categorised by therapeutic area, and differences in population scope and pricing between early access and launch were assessed.
RESULTS: Among 17 therapies granted early access, 5 were reimbursed with publicly available data showing differences between AAP and launch populations. The mean AAP price was 9% lower than the mean launch price (€41,458 versus €45,735). List prices remained unchanged for 24% (n=4) of the products, increased for 29% (n=5) and decreased for 46% (n=8). The time from AAP start to reimbursement ranged from 49 to 365 days and 50% of therapies were for oncology indication, 38% orphan diseases and 12% infectious diseases.
CONCLUSIONS: French early access programmes typically limit use to narrower, high-need populations. Most therapies launched with the same indication and little to no price change, demonstrating the importance for manufacturers to consider European pricing strategies early in the access pathway. These patterns offer important insights for manufacturers planning launch and pricing strategies, particularly in high-priority areas like oncology and orphan diseases.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HPR37
Topic
Health Policy & Regulatory
Topic Subcategory
Reimbursement & Access Policy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas