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Aflibercept in colorectal cancer: Indication of minor added benefit
Date:7/11/2013

ed by 1 to 2 months on average (median). For overall survival, this led to an indication of an added benefit with the extent "considerable" for the combination of aflibercept with FOLFIRI in comparison with FOLFIRI alone.

The manufacturer's dossier did not provide any results, or any results that could be used, on symptoms and complaints (morbidity) and health-related quality of life. Hence an added benefit of aflibercept in comparison with the appropriate comparator therapy for these outcome categories is not proven.

Side effects: indications of greater harm

Serious events and severe adverse events (e.g. infection, diseases of organs, metabolism, blood and lymph system) as well as treatment discontinuations due to severe adverse events were more frequent during the treatment with aflibercept than during the treatment with FOLFIRI alone in all age groups.

In summary, there is an indication of greater harm with major extent from the treatment with aflibercept plus FOLFIRI in comparison with FOLFIRI alone for several outcomes of the category side effects.

Overall, indication of minor added benefit

Overall, positive effects of aflibercept are accompanied by negative effects with the same certainty of results: the indication of a considerable added benefit in mortality (overall survival) has to be weighed up against the indications of greater harm with major extent regarding side effects. IQWiG therefore downgrades the extent of the added benefit of aflibercept in comparison with the appropriate comparator therapy from "considerable" to "minor".

IQWiG published a first assessment of aflibercept (trade name: Eylea) on 15th March 2013. This dealt with a different therapeutic indication, however, namely the "treatment of wet age-related macular degeneration (AMD)".

G-BA decides on the extent of added benefit

The dossier assessment is part of the overall procedure for ear
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Contact: IQWiG
presse@iqwig.de
49-022-135-6850
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

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