Presentation (CTI)

OBJECTIVES: Since 2013, economic evaluations have supported pricing and reimbursement decisions for selected innovative health technologies in France. The French Economic and Public Health Assessment Committee (CEESP) assesses these evaluations according to national methodological guidelines issued by the Haute Autorité de Santé (HAS). While several studies have examined economic evaluations of pharmaceuticals, little is known about the characteristics and methodological challenges of medical device evaluations submitted to CEESP. This study aimed to characterize medical device economic evaluations submitted to CEESP and identify the main methodological issues raised during the assessment process.
METHODS: A retrospective review of all publicly available CEESP efficiency opinions on medical devices published between 2015 and June 2025 was conducted. Data were extracted from the VYOO Agency efficiency database synthesis of these opinions. Descriptive statistical analyses were performed.
RESULTS: Twenty-four efficiency opinions were identified. Most submissions concerned first registrations (n=9) or indication extensions (n=7). Cardiology accounted for 75% of evaluations (18/24), predominantly involving left-sided valvular heart diseases. Medtronic (33%) and Abbott (25%) were the most frequently represented manufacturers.Among the 24 assessments, 10 incremental cost-effectiveness ratios (ICERs) expressed as €/QALY were considered valid by CEESP, corresponding to a validation rate of 42%. The mean ICER among valid results was €80,185/QALY, with values ranging from €5,893 to €232,739/QALY.A total of 183 methodological reservations were identified. On average, each assessment included 1.17 major, 3.75 important, and 2.71 minor reservations. Major reservations were mainly associated with modeling choices, structural assumptions, and utility estimates. During the technical exchange phase, CEESP issued an average of 46.6 technical questions per assessment.
CONCLUSIONS: Medical device economic evaluations submitted to CEESP frequently face methodological concerns. The relatively low ICER validation rate highlights the challenges of demonstrating economic value within the current French HTA framework and raises questions about the suitability of methodological guidelines largely developed for pharmaceuticals, particularly in oncology.