Was it worth introducing health economic evaluation of innovative drugs in the french regulatory setting : the case of new drugs against Hepatitis C Virus

Abstract : The paper draws lessons from the recent uptake of health economic evaluation of innovative drugs in the French regulatory framework.Taking the example of new direct-acting antivirals against Hepatitis C virus the paper asks whether and how the Cost-Effectiveness (CE) Opinions issued by the French National Health Authority improve the information available to support the pricing decisions.The results show that CE Opinions bring to the fore 3 issues prone to impact the Incremental Cost Utility Ratio and that were not available to the decision-maker through Clinical Opinions or published CUA: the stage of treatment initiation, the modeling of the disease progression and the uncertainty around the efficacy rates.