IQWiG finds no added benefit for Astellas' Betmiga

Japanese drug major Astellas Pharma's (TYO: 4503) Betmiga (mirabegron), which has been approved in Germany since December 2012 for the treatment of adults with overactive bladder, failed to win the backing of the country’s drug cost:benefit evaluator.

In an early benefit assessment under the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether Betmiga offers an added benefit over the appropriate comparator therapy specified by the Federal Joint Committee (G-BA).

The IQWiG said that mirabegron had an advantage with regard to side effects: Dry mouth was less common in comparison with tolterodine. However, no added benefit could be determined for the outcomes “mortality,” “morbidity” and “quality of life.” 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.