[A20-08] Upadacitinib (rheumatoid arthritis) - Benefit assessment according to §35a Social Code Book V

Last updated 16.07.2020

Project no.:

Commission awarded on 16.01.2020 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Commission completed

Drug Assessment

Application field:
Muscles, bones and joints


Adults with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to DMARDs

Result of dossier assessment:

First treatment with bDMARDs or tsDMARDs indicated: for combination with MTX indication of considerable added benefit. Patients with high disease activity who have responded inadequately to, or who are intolerant to one or more bDMARDs and/or tsDMARDs: for combination with MTX indication of minor added benefit. Monotherapy and other patient groups: added benefit not proven.


The current version 1.1 of the dossier assessment replaces version 1.0 published on 2020-05-04.

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.

Accompanying information

Further information for consumers and patients is provided on IQWiG's health information website www.informedhealth.org.


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