OBJECTIVES: In France, the CEESP (Economic & Public Health Assessment Commission) oversees health economic appraisal of medical technologies when requested concomitantly with a reimbursement demand. This appraisal establishes the methodological acceptability of the health economic dossier submitted. Methodological acceptability is defined through methodological reservations qualified as minor, important or major. A major reservation invalidates the dossier and the economic value that it defends. An appraisal also specifies the level of uncertainty surrounding the results. A major uncertainty invalidates the results and the dossier per se. Uncertainty could be driven by the difficulty to estimate key parameters, by a lack of credibility of hypotheses or interpretability of the results. Using Vyoo Agency efficiency database, the objective is to analyze the main reasons retained by the CEESP to invalidate the economic information among health economic appraisals published in 2022.

METHODS: All available Health Economic appraised by CEESP between January 1^st and until December 31^th, 2022, were reviewed.

RESULTS: In 2022, 28 appraisals were disclosed, 15 of which were invalidated. Fourteen major methodological reservations were stated, invalidating 10 dossiers. The major reservations relate to relative effectiveness modelling (7), utility estimation (5) and sensitivity analyses (2). Relating to the modelling of the treatment effect, 4 reservations concern indirect comparisons and 3 hypotheses used to model the relative effect regarding available data. In addition, 4 dossiers were invalidated due to major uncertainty mainly supported by the evolving context (3 opinions which 2 on COVID-19 treatments) or statistical variability of the parameters (1). One evaluation was not assessable.

CONCLUSIONS: In 2022, less than 50% of dossier were likely to provide valuable economic information in the decision-making process in France. Reducing the number of invaluable assessments is a key issue to ensure economic information can be fully used in pricing negotiations.