[A21-115] Tofacitinib (rheumatoid arthritis) - Benefit assessment according to §35a Social Code Book V (new scientific findings)
Last updated 17.02.2022
Project no.:
A21-115
Commission:
Commission awarded on 31.08.2021 by the Federal Joint Committee (G-BA).
Report type:
Dossier assessment
Status:
Commission completed
Department/Division:
Drug Assessment
Application field:
Muscles, bones and joints
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
Note:
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| Project no. | Title | Status |
|---|---|---|
| A18-52 | Tofacitinib (Colitis) - Benefit assessment according to §35a Social Code Book V | Commission completed |
| A18-51 | Tofacitinib (psoriatic arthritis) - Benefit assessment according to §35a Social Code Book V | Commission completed |
| A18-28 | Tofacitinib (rheumatoid arthritis) - Benefit assessment according to §35a Social Code Book V (expiry of the decision) | Commission completed |
| A17-18 | Tofacitinib (rheumatoid arthritis) - Benefit assessment according to §35a Social Code Book V | Commission completed |
| A21-121 | Tofacitinib (jPsA and pJIA) - Benefit assessment according to §35a Social Code Book V | Commission completed |
| G22-03 | Tofacitinib (rheumatoid arthritis) - Addendum to Commission A21-115 | Commission completed |
| A21-165 | Tofacitinib (ankylosing spondylitis) - Benefit assessment according to §35a Social Code Book V | Commission completed |
Federal Joint Committee (G-BA)
2022-02-17 A G-BA decision was published.