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Belimumab for lupus erythematosus: Added benefit not proven
Date:8/29/2012

ffects between the belimumab and comparator groups might have been smaller, or indeed totally absent.

A study design of this type is suitable for approval purposes, but not for a benefit assessment in accordance with 35a Social Code Book (SGB) V, as the purpose of the latter is to determine added benefit in comparison to an alternative treatment option. According to the specifications of the G-BA for the specific case of belimumab, this is solely the optimization of standard therapy.

Relevant study excluded

On the one hand, the manufacturer argues on the basis of these two unsuitable studies in the dossier. On the other hand, another study (LBSL02) is explicitly excluded, even though optimization of the standard therapy was possible here. This study would have been relevant for the assessment. IQWiG cannot support the justification for excluding the study. Thus the pharmaceutical company has not presented any relevant studies or analyses of study data in its dossier.

G-BA decides on the extent of added benefit.

The dossier assessment is part of the overall procedure for early benefit assessment conducted by the G-BA. After publication of the manufacturer's dossier and its assessment by IQWiG, the G-BA initiates a formal commenting procedure which can 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: Dr. Anna-Sabine Ernst
presse@iqwig.de
49-022-135-6850
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

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