IQWiG finds no added benefit for Myrbetriq in Overactive Bladder-Astellas

In an early benefit assessment, the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether Myrbetriq/Betmiga (mirabegron), from Astellas, offers an added benefit over the appropriate comparator therapy for Overactive Bladder, and found that though mirabegron had an advantage with regard to side effects (dry mouth was less common in comparison with tolterodine), no added benefit could be determined for the outcomes �mortality�, �morbidity� and �quality of life�.

IQWiG included one long-term study (179-CL-049) in the assessment, which the manufacturer had reported, but not used to derive an added benefit. There were no relevant differences between the treatment groups in severity, frequency and impairments due to the urge to urinate or in the frequency of nocturia. As the drug manufacturer dossier contained no analyses for the total population on the patient-relevant morbidity criteria �incontinence� and �urge incontinence�, it was not possible to conduct a final balancing of positive and negative effects on the added benefit. Overall, an added benefit of mirabegron is therefore not proven.