OP60 Methodological Guidance And Doctrine Of The French National Authority For Health For Economic Evaluation

Introduction The French National Authority for Health (HAS) “defines and issues guidelines and medico-economic opinions on prevention, healthcare, prescription, and best care strategies, and contributes to their comparison or ranking to support public health and optimize health insurance spending.” Based on a decade of producing cost-effectiveness evaluations, the Economic Evaluation and Public Health Committee (CEESP) issued two documents to frame its activity related to the economic evaluation of health products: (i) the new guidance highlights the expectations of the CEESP regarding cost-effectiveness evaluations; (ii) the doctrine elucidates the grading of methodological reservations expressed during the technical appraisal of manufacturers’ submissions, the CEESP’s statements regarding its findings, and the key messages it wishes to convey to public decision-makers, especially to negotiate healthcare product prices. Methods We aim at sharing the content of these documents and describing the willingness of the CEESP to support decision-makers in implementing evidence-based pricing policies. Results The new guidance provided an opportunity for HAS to stress the importance of interpreting the evaluations, which are often perceived as highly technical. In this perspective, several guidelines call for more reasoned reflection on the objectives of the evaluation upon its conception, along with a constant effort to justify the methodological choices made and an extensive interpretation of the results produced. The doctrine highlights two steps taken by the CEESP, mainly built on analyzing the cost-effectiveness evaluation’s uncertainty. First, the ability to characterize the level of the ICER in a context where no thresholds for willingness-to-pay exist in France; second, the suggestion of specific regulation schemes to increase the cost-effectiveness of the products. Conclusions The CEESP developed the new guidance and its doctrine as conditions to ensure the usefulness of the economic evaluation for decision-making.