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Perampanel for epilepsy: No proof of added benefit
Date:1/30/2013

iramate was "not productive". But IQWiG does not accept this explanation from the manufacturer.

Comparisons with lamotrigine not adequate

In order to demonstrate the added benefit over lamotrigine, the manufacturer provided data on a direct and an indirect comparison. However, ultimately the former comparison was with a dummy drug (a placebo). Although in this case a placebo comparison can prove a benefit, it cannot prove an added benefit.

For various reasons, the indirect comparison is also inadequate. Amongst other things, perampanel was not tested here against lamotrigine (in each case as add-on therapy), but instead a combination of perampanel and lamotrigine against lamotrigine, in each case in addition to basic treatment, was tested.

Since neither the indirect nor the direct comparisons are suitable for answering the research question, no relevant study results are available for the benefit assessment. Hence there is also no proof of an added benefit.

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.


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Contact: Anna-Sabine Ernst
presse@iqwig.de
49-221-356-85153
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

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