From French Early Access to Regular Reimbursement: How Do Prices Shift Post-HTA?
Author(s)
Malek Dimassi, MEng1, Nour Grioui, MEng1, Cecile Remuzat, PharmD2, Eve Hanna, PharmD, MSc, PhD2, Clement Francois, PhD2.
1Putnam, Tunis, Tunisia, 2Putnam, Paris, Île-de-France, France.
1Putnam, Tunis, Tunisia, 2Putnam, Paris, Île-de-France, France.
OBJECTIVES: In France, early access (EA) enables timely patient access to innovative therapies for serious or rare conditions with high unmet medical need. During EA, manufacturers can freely set EA prices (EAPs) while final negotiated list prices (NPs) are influenced by clinical added value (ASMR). To address potential overpayment, if the NP is lower than the EAP, manufacturers must repay the difference. This study analyses pricing trends by comparing EAPs and NPs and explores how price differentials relate to ASMR levels.
METHODS: Drugs with terminated EA post-reimbursement up to April 2025 were identified via the Ministry of Health database. EAPs were sourced from the Ministry of Health database, NPs from the national health insurance database, and ASMR levels for indications covered in EA from corresponding reimbursement reports.
RESULTS: Eighty-one drugs with available EAP and NP data were included. In 83% (67/81) of cases, NPs were lower than EAPs, with reductions ranging from -0.43% to -84% - the latter observed for a product granted ASMR IV/V and ASMR V in two assessments. EAPs were maintained in only 11 cases, 91% (10/11) of which had ASMR III or IV. NPs exceeded EAPs in only 3 instances (by 2%, 5%, and 11%) for products with ASMR III or IV, all indicated in rare or ultrarare conditions and assessed for their first indication. For all ASMR V products, NPs were lower than EAPs; 64% (7/11) had reductions of 25-84%. Among ASMR III or IV products, 60% (40/67) had unchanged or <15% reduced NPs.
CONCLUSIONS: Most EAP are not sustained post-reimbursement. No clear correlation between ASMR and EAP-NP differential was found, except for ASMR V which was consistently linked to NP reductions. However, as NPs may include confidential rebates, observed differentials could underestimate true post-reimbursement net prices. Manufacturers should set EAPs cautiously, accounting for ASMR outcomes and rebate obligations.
METHODS: Drugs with terminated EA post-reimbursement up to April 2025 were identified via the Ministry of Health database. EAPs were sourced from the Ministry of Health database, NPs from the national health insurance database, and ASMR levels for indications covered in EA from corresponding reimbursement reports.
RESULTS: Eighty-one drugs with available EAP and NP data were included. In 83% (67/81) of cases, NPs were lower than EAPs, with reductions ranging from -0.43% to -84% - the latter observed for a product granted ASMR IV/V and ASMR V in two assessments. EAPs were maintained in only 11 cases, 91% (10/11) of which had ASMR III or IV. NPs exceeded EAPs in only 3 instances (by 2%, 5%, and 11%) for products with ASMR III or IV, all indicated in rare or ultrarare conditions and assessed for their first indication. For all ASMR V products, NPs were lower than EAPs; 64% (7/11) had reductions of 25-84%. Among ASMR III or IV products, 60% (40/67) had unchanged or <15% reduced NPs.
CONCLUSIONS: Most EAP are not sustained post-reimbursement. No clear correlation between ASMR and EAP-NP differential was found, except for ASMR V which was consistently linked to NP reductions. However, as NPs may include confidential rebates, observed differentials could underestimate true post-reimbursement net prices. Manufacturers should set EAPs cautiously, accounting for ASMR outcomes and rebate obligations.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA151
Topic
Health Technology Assessment
Disease
No Additional Disease & Conditions/Specialized Treatment Areas