[A19-94] Belimumab (SLE) - Benefit assessment according to §35a Social Code Book V

Last updated 17.02.2020

Project no.:

Commission awarded on 15.11.2019 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Commission completed

Drug Assessment

Application field:
Muscles, bones and joints


Children aged 5 years and older and adolescents with active, autoantibody-positive SLE with a high degree of disease activity despite standard therapy

Result of dossier assessment:

Added benefit not proven due to lack of interpretable study data


After completion of the assessment by IQWiG the Federal Joint Committee (G-BA) conducts a commenting procedure. This may provide supplementary information and as a result lead to a modified benefit assessment. Further information and the decision on the early benefit assessment can be found on the relevant page of the G-BA website.


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