Germany's IQWiG finds no proof of added benefit for Bayer's Eylea

There was disappointment for German drug major Bayer (BAYN: DE), when the German Institute for Quality and Efficiency in Health Care (IQWiG) gave its opinion that its wet age-related macular degeneration treatment Eylea (aflibercept) offers no added benefit over the current standard therapy.

Such an added benefit cannot be derived from the dossier, however, as the manufacturer did not submit any suitable data for this comparison, the IQWiG said following its assessment under the Act on the Reform of the Market for Medicinal Products (AMNOG). The drug has been approved in Germany for this indication since November 2012.

The Federal Joint Committee (G-BA) specified the drug ranibizumab (Novartis’ Lucentis) as appropriate comparator therapy. In its dossier Bayer cited two approval studies of aflibercept that directly compared aflibercept with ranibizumab. But in these studies, ranibizumab was not used according to its approval status. For instance, the continuation or discontinuation of treatment was not made dependent on whether the patients had achieved stable visual acuity or not.