Reimbursement agency requirements for health related quality-of-life data: a case study.

A review was undertaken to identify relevant and appropriate heath-utility estimates for patients with atrial fibrillation who had stroke and to appraise them against the published requirements for several countries' Health Technology Assessment agencies: Australia (Pharmaceutical Benefits Advisory Committee), Canada (Common Drug Review), England and Wales (NICE), Germany (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen), Scotland (Scottish Medicines Consortium) and Sweden (Tandvårds-och läkemedelsförmånsverket). National agencies have created guidelines to support economic evaluations for their own countries but these guidelines differ. It may be more appropriate for agencies to be concerned primarily with the methodological quality of studies that report utilities rather than identifying local values. As such, we recommend some steps that could be considered when assessing the quality of utility studies in a systematic review or meta-analysis. These steps include considering the methods of utility estimation, model needs, generalizability, sample size and the use of large databases. This may, thus, facilitate consistent and rational Health Technology Assessment decision making.