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Long struggle for appropriately processed manufacturer data leads to a new assessment of memantine
Date:4/27/2011

After the manufacturer of the Alzheimer's drug memantine submitted a supplementary analysis of study data, the German Institute for Quality and Efficiency in Health Care (IQWiG) sees proof of a benefit of the drug for cognitive function, as well as indications of a benefit for activities of daily living, at least for a treatment period of 6 months. This changes the conclusions of the first IQWiG benefit assessment of 2009. IQWiG had repeatedly called upon the manufacturer Merz to provide a renewed analysis of study data appropriate to the research question.

Additional effort may also be worthwhile for manufacturers

IQWiG's Director Jrgen Windeler comments on the new assessment result: "As in many other projects, in the assessment of memantine the Institute was also confronted with gaps in the evidence. If this is the case, then we make suggestions as to how these gaps can be closed. Sometimes additional new studies are required; sometimes it suffices if the manufacturer provides or supplements data already available, as was the case for memantine. In the end, the additional effort paid off."

In the first IQWiG assessment, data from two studies were missing

In Germany the drug memantine is marketed under the tradenames "Axura" and "Ebixa", and is approved for the treatment of moderate to severe Alzheimer's disease. In a first benefit assessment , prepared after commissioning by the Federal Joint Committee (G-BA) and published in September 2009, IQWiG found no proof that patients with Alzheimer's disease could benefit from memantine. However, among other things, relevant information on two studies was missing, which the manufacturer had not provided to IQWiG.

Additional analysis did not consider all of the relevant studies

At the beginning of 2010, Merz submitted the results of these two studies, as well as additional analyses of a larger number of studies, to the G-BA. IQWiG subsequentl
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Contact: IQWiG
info@iqwig.de
49-022-135-6850
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

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