Mar 15, 2013
Aflibercept in AMD: no proof of added benefit
Manufacturer's dossier did not contain any usable data for the comparison with ranibizumab
The drug aflibercept (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, however, as the manufacturer did not submit any suitable data for this comparison.
Patients in control group did not receive approval-compliant treatment
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. Although the manufacturer cited other documents in its dossier, these cannot be used for the benefit assessment, as they do not allow any reliable conclusions to be drawn on the comparison of aflibercept and ranibizumab. Overall, no added benefit of aflibercept can be derived from the data presented in the dossier.
G-BA decides on the extent of added benefit
The dossier assessment is part of the overall procedure for early benefit assessments supervised by the G-BA. After publication of the manufacturer's dossier and IQWiG's assessment, the G-BA 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.
An overview of the results of IQWiG's benefit assessment is given by a German-language executive summary. In addition, the website gesundheitsinformation.de, published by IQWiG, provides easily understandable and brief German-language information on aflibercept.
The G-BA website contains both general English-language information on benefit assessment pursuant to §35a Social Code Book V and specific German-language information on the assessment of aflibercept.
More English-language information will be available soon (Sections 2.1 to 2.6 of the dossier assessment as well as subsequently published health information on www.informedhealthonline.org). If you would like to be informed when these documents are available, please send an e-mail to info@iqwig.de.
