Update on submission of a dossier for an economic opinion from the CEESP in France

In July 2026, the French National Authority for Health (HAS) updated its guidance on submitting dossiers for an economic opinion by the Economic and Public Health Evaluation Commission (CEESP).

For any application for inclusion on reimbursement lists (initial listing, an indication extension, or a renewal), manufacturers claiming a Clinical Added Value (ASA) or Actual Medical Benefit (ASMR) rating of I, II, or III must complete an electronic submission form through SESAME, the HAS submission platform. Where the product is also expected to have a significant impact on statutory health-insurance expenditure, an economic evaluation dossier must be submitted at the same time. A non-concurrent submission will be considered inadmissible until both components have been received. Submissions by post or email are not accepted.

The July 2026 update includes a procedural guide on pre-submission meetings with the HAS Economic Evaluation Service (SEE). These meetings are intended to help manufacturers identify the most appropriate methodological choices and prepare economic evaluations that are consistent with HAS recommendations. Questions may concern the proposed cost-outcome analysis and, where applicable, the budget impact analysis.

Pre-submission meetings are optional, confidential, non-binding, and free of charge. The SEE’s responses are based on the information available at the time of the meeting, do not prejudge the subsequent critical assessment of the submitted dossier, and do not bind the CEESP when it adopts its economic opinion.

Requests must relate to specific, complex, and potentially high-impact methodological choices for which existing HAS guidance does not provide an answer suited to the dossier concerned. The economic evaluation must be sufficiently advanced for the manufacturer to present the proposed objective, protocol, comparators, perspective, time horizon, and modeling approach. HAS recommends scheduling the meeting for at least three months before the anticipated submission or pre-submission date. 

Pre-submission meetings are not available for re-evaluations, and additional eligibility restrictions apply where the product has already been discussed with HAS for the same indication.

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