No abstract

A791between 2010 and 2015 were conducted. For each CAV appraisal, information regarding the level of evidence and clinical effectiveness was collected. Results: Twenty antiviral drugs (47 indications) were assessed. All obtained a favourable opinion for reimbursement with 11 a major to moderate CAV, 14 a minor and 22 no CAV. No one obtained a major CAV. The majority of studies [46% (22/47)] were non-active comparator studies based on virological response and supported an important to moderate CAV in 32% (7/22), as sofosbuvir that granted the highest CAV level (important CAV). Among the 19 comparative trials, 68% (13/19) were of superiority design supporting a major to moderate CAV in 31% (4/13) of the cases. A higher proportion of important to moderate CAV were observed in trials using a relevant primary endpoint (26%) versus no one for a study using an exploratory endpoint such as pharmacokinetic endpoint. ConClusions: A high proportion (53%) of CAV is recognized in virology compared to the other therapeutic areas (15%) while non-active comparator studies are made. This report shows that HAS appraisals remain multi-factorial. HAS' expectations in terms of level of evidence take into account the medical need, therapeutic area specificity and a rapid evolution of the therapeutic strategy. The emergence of anti-viral drug resistance can also influence the CAV appraisal.

diabetes. Diabetic patients treatment acceptance is primarily driven by perceived effectiveness. Long-term treatment is their major concern. These findings give indications about T1D and T2D patients' priorities and unmet needs.