Analysis of Cost-Effectiveness Assessments In France By The French National Authority For Health (Has).

Abstract

In France, cost-effectiveness assessment is required since October 3rd 2013 for innovative health products and are likely to have a significant impact on the health insurance expenditures. The objective of this work is to report first cost-effectiveness assessments, achieved by the Health Economics and Public Health Committee (CEESP) of the French National Authority for Health (HAS). The investigation consists in analyzing medico-economic dossiers submitted at the CEESP between October 2013 and October 2014. This analysis is based on the opinion delivered by the CEESP, the methodology used in the model and the process of the assessment achieved by the HAS. At the time of writing the abstract, 15 dossiers were eligible for cost-effectiveness assessment. All dossiers were based on cost-utility models. Two dossiers presented a negative opinion due to the methodological conformity according to HAS guidelines. For dossiers with a positive opinion, the Incremental Cost-Effectiveness Ratio (ICER) were between 5 866€/QALY (for a subgroup analysis) and 194 531 €/QALY. Main methodological reserves made by the CEESP concerned comparators, time horizon, robustness of clinical data, utility measures. The average processing time was 94,8 days. For the moment, no price has been published in the Official Journal. The first assessments permit to confirm that the procedure is operational. In light of these first assessments, an update of the HAS methodological guidelines should be done. In France, without efficiency threshold value, the CEESP can’t conclude absolutely on the efficiency of health products. Thus, we don’t know what will be the place of the ICER in the pricing negotiation between the pharmaceutical industry and the French Healthcare Products pricing Committee (CEPS).