Dossier assessment

Tofacitinib (rheumatoid arthritis) - Benefit assessment according to §35a Social Code Book V (new scientific findings)

Report documents

Indication:

Adults with moderate to severe active rheumatoid arthritis

Result of dossier assessment:

Patients without poor prognostic factors who have responded inadequately to or who have not tolerated prior treatment with a disease-modifying antirheumatic drug (conventional synthetic DMARDs, including methotrexate): added benefit not proven
Patients for whom a first therapy with biologic DMARDs or targeted synthetic DMARDs is indicated: added benefit not proven
Patients who have responded inadequately to or who have not tolerated prior treatment with one or more biologic DMARDs and/or targeted synthetic DMARDs: added benefit not proven

Federal Joint Committee (G-BA)

2022-02-17 A G-BA decision was published.

Project no.: A21-115
Commission: Commission awarded on 31.08.2021 by the Federal Joint Committee (GBA).
Report type: Dossier assessment
Status: Commission completed
Department/Division: Drug Assessment
Topic: Muscles, bones and joints
Note: After completion of the assessment by IQWiG the Federal Joint Committee (GBA) 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 GBA website.

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