What Are the Impacts of the Absence of Health Economic Evaluations for Drugs Granted an ASMR IV Rating by the French National Authority of Health (HAS)? An Analysis of Medicines Assessed Between May 2022 and May 2024
Author(s)
Hélène Moutier, Pharm D, Salomé Rabarioelina, Student, Sandrine Bourguignon, MSc, PhD.
Rweality, Paris, France.
Rweality, Paris, France.
OBJECTIVES: In France, the Haute Autorité de Santé (HAS) conducts economic evaluations (EEs) to support public decision-making. However, an EE for drug is required only when specific eligibility criteria are met: a first-time or extended market access request, a claimed added clinical benefit (ASMR) of level I to III, and a significant anticipated impact on public health spending or care delivery. Consequently, drugs with a claimed ASMR of level IV or V are excluded from the EE process, despite their potential organizational or public health impacts. This study explores how this exclusion limits the economic understanding of such drugs and assesses the potential value of expanding the EE framework.
METHODS: A descriptive analysis was performed on all HAS evaluations published between May 2022 and May 2024. For each drug assigned an ASMR IV, we identified whether an EE had been submitted. Reimbursement setting (retail and/or hospital) and hospital financing mechanisms were also documented.
RESULTS: Of 87 ASMR IV evaluations, 30% included an EE, suggesting these products had initially claimed a higher ASMR level (I to III). The remaining 70% were assessed without economic input. Of these, 38% were first-time submissions for reimbursement and 26% involved drugs with substantial medical benefit (SMR). Despite their public health relevance, none of these cases were supported by a medico-economic model. These drugs include pediatric vaccines, etc., products that may entail significant organizational or budgetary consequences for the health system. The lack of economic evidence for such products raises questions about the completeness of information available for decision-making, especially in cases where these medicines are also subject to public budget impact considerations.
CONCLUSIONS: A significant number of drugs with potential collective impact are excluded from economic analysis in France. EE criteria could enhance decision-making by better capturing externalities, both for national reimbursement and hospital procurement.
METHODS: A descriptive analysis was performed on all HAS evaluations published between May 2022 and May 2024. For each drug assigned an ASMR IV, we identified whether an EE had been submitted. Reimbursement setting (retail and/or hospital) and hospital financing mechanisms were also documented.
RESULTS: Of 87 ASMR IV evaluations, 30% included an EE, suggesting these products had initially claimed a higher ASMR level (I to III). The remaining 70% were assessed without economic input. Of these, 38% were first-time submissions for reimbursement and 26% involved drugs with substantial medical benefit (SMR). Despite their public health relevance, none of these cases were supported by a medico-economic model. These drugs include pediatric vaccines, etc., products that may entail significant organizational or budgetary consequences for the health system. The lack of economic evidence for such products raises questions about the completeness of information available for decision-making, especially in cases where these medicines are also subject to public budget impact considerations.
CONCLUSIONS: A significant number of drugs with potential collective impact are excluded from economic analysis in France. EE criteria could enhance decision-making by better capturing externalities, both for national reimbursement and hospital procurement.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
EE752
Topic
Economic Evaluation, Health Policy & Regulatory, Health Technology Assessment
Disease
No Additional Disease & Conditions/Specialized Treatment Areas