The aim of the present report is to assess the added benefit of mirabegron compared with the appropriate comparator therapy (ACT) in symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome.
The Federal Joint Committee (G-BA) specified treatment with one of the following drugs as ACT for this therapeutic indication: darifenacin, fesoterodine, flavoxate, propiverine, solifenacin, tolterodine and trospium chloride.
Following the G-BA’s specification, the company chose tolterodine as the ACT. However, it limited its choice to extended-release formulations of tolterodine, although immediate-release formulations of tolterodine are also approved for the therapeutic indication. According to the G-BA’s specification at drug level, all formulations of tolterodine are to be considered. The company’s limitation had no consequence, however, because it did not change the study pool for direct comparative studies.
The dossier assessment was conducted in comparison with the ACT tolterodine.
The assessment was based on patient-relevant outcomes. Only direct comparative randomized controlled trials (RCTs) were included in the assessment.
Keywords: mirabegron; micturition; overactive bladder syndrome; urinary incontinence.
Copyright © 2014 by the Institute for Quality and Efficiency in Healthcare (IQWiG).