Budget Impact Models in CEESP Opinions: A Decade of Insights
Author(s)
Olfa Doghri, MSc1, Yosra Boukhris, MD2, Marine Sivignon, PharmD3, Romain Supiot, MSc1, Rahma Sellami, PharmD1, Nicolas Virely, MSc1.
1Putnam, Paris, France, 2Putnam, Tunis, Tunisia, 3Putnam, Lyon, France.
1Putnam, Paris, France, 2Putnam, Tunis, Tunisia, 3Putnam, Lyon, France.
OBJECTIVES: Since 2013, pharmaceutical and medical device (MD) companies in France are required to submit cost-effectiveness analyses to the Haute Autorité de Santé (HAS) for innovative products. Budget impact model (BIM) submissions were optional. Under the 2015 CEPS-LEEM (Comité Economique des Produits de Santé - Les Enterprises du Médicament) framework agreement, BIMs became mandatory for drugs with an added therapeutic value (ASMR) I to III and projected net sales exceeding €50 million in the second year. In 2016, HAS issued methodological guidelines detailing expectations on BIM. Subsequently, the 2021 framework agreement between the same entities reaffirmed these requirements under Article 12d, maintaining the same BIM-submission conditions. This study reviews HAS-published BIM-including economic opinions (EOs), focusing on methodological reservations (MRs) and their evolution following the 2016 guidelines and subsequent framework agreements.
METHODS: CEESP (Commission d’Evaluation Economique et de Santé Publique)-issued EOs through December 2024 were compiled into an internal database. Data on BIM inclusion, submission type, therapeutic area, methodological reservations, and critical appraisal were extracted.
RESULTS: Between 2014 and 2024, 238 EOs were published, of which 152 (64%) included a BIM. BIM submissions increased over time: 17% in 2014-2015, 70% in 2016-2021, and 79% in 2022-2024. Most BIM-related EOs concerned indication extensions (50%) and initial reimbursement (42%). Oncology represented the largest share (54%), followed by cardiology (12%), neurology and virology (7% each). A total of 448 BIM related MRs were identified, including 24 major ones , which largely aligned with those raised in cost-effectiveness analyses.
CONCLUSIONS: BIMs have gained prominence in CEESP submissions, driven by evolving regulatory requirements. Now present in most dossiers, they play a central role in France’s pricing and reimbursement framework. Despite persistent methodological issues, often paralleling those in cost-effectiveness analyses, harmonisation remains critical to prevent challenges during health technology assessments.
METHODS: CEESP (Commission d’Evaluation Economique et de Santé Publique)-issued EOs through December 2024 were compiled into an internal database. Data on BIM inclusion, submission type, therapeutic area, methodological reservations, and critical appraisal were extracted.
RESULTS: Between 2014 and 2024, 238 EOs were published, of which 152 (64%) included a BIM. BIM submissions increased over time: 17% in 2014-2015, 70% in 2016-2021, and 79% in 2022-2024. Most BIM-related EOs concerned indication extensions (50%) and initial reimbursement (42%). Oncology represented the largest share (54%), followed by cardiology (12%), neurology and virology (7% each). A total of 448 BIM related MRs were identified, including 24 major ones , which largely aligned with those raised in cost-effectiveness analyses.
CONCLUSIONS: BIMs have gained prominence in CEESP submissions, driven by evolving regulatory requirements. Now present in most dossiers, they play a central role in France’s pricing and reimbursement framework. Despite persistent methodological issues, often paralleling those in cost-effectiveness analyses, harmonisation remains critical to prevent challenges during health technology assessments.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA61
Topic
Economic Evaluation, Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes, Value Frameworks & Dossier Format
Disease
No Additional Disease & Conditions/Specialized Treatment Areas