Presentation (CTI)

OBJECTIVES: Main goal for companies submitting an economic dossier is to avoid invalidation of the opinion by the French Economic and Public Health Committee (CEESP). In 2025, a turning point was reached, with only 9.5% of opinions issued by the CEESP invalidated, compared with 41% and 53% in 2023 and 2024 respectively. This study analyzed CEESP deliberation transcripts of non-invalidated opinions in 2025 to identify recurring patterns explaining this decline and compared them with transcripts from 2023 and 2024.
METHODS: All publicly available deliberation transcripts for non-invalidated CEESP opinions issued in 2025 (n=19 of 21 total opinions) were reviewed. Three qualitative categories were inductively identified: 1/ mention of dossier quality/simplicity; 2/ evidence that companies addressed CEESP's remarks during the technical exchange; 3/ reference to the opinion's use in price negotiations. The same grid was applied to non-invalidated CEESP opinions issued in 2024 (n=9) and 2023 (n=10).
RESULTS: Companies' responsiveness to CEESP's technical remarks was noted in 47% of non-invalidated 2025 transcripts, versus 11% in 2024 and 20% in 2023. Reference to the opinion's downstream use in price negotiations and/or willingness to inform CEPS appeared in 58% of 2025 transcripts, versus 33% in 2024 and 20% in 2023. Dossier quality was mentioned in 37% of 2025 transcripts, versus 44% in 2024 and 30% in 2023.
CONCLUSIONS: The 2025 decline in CEESP invalidation rates coincides with increased company engagement during technical exchanges and greater reference to opinions' use in price negotiations, while reference to dossier quality remained stable across the three years. These findings suggest a shift toward more pragmatic use of CEESP opinions, beyond dossier quality alone, warranting further investigation into the drivers and sustainability of this trend.