The drug aflibercept, under the trade name Eylea, has been approved in Germany since November 2012 for the treatment of wet age-related macular degeneration (AMD).
In an early benefit assessment pursuant to 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 this new drug offers an added benefit over the current standard therapy. Such an added benefit cannot be derived from the dossier, since the manufacturer did not submit data for the comparison, says the advocacy group in Germany.
The dossier assessment is part of the overall procedure for early benefit assessments supervised by the Federal Joint Committee. After publication of the manufacturer's dossier and IQWiG's assessment, the
Federal Joint Committee
conducts a commenting procedure, which may provide further information and result in a change to the benefit assessment.
The G-BA then decides on the extent of the added benefit, thus completing the early benefit assessment.
The Federal Joint Committee (G-BA) specified the drug ranibizumab as appropriate comparator therapy. In its dossier the pharmaceutical company 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.
The manufacturer cited other documents in its dossier but for the benefit assessment, as they do not allow any reliable conclusions to be drawn on the comparison of aflibercept and ranibizumab.