Addendum
Tofacitinib (rheumatoid arthritis) - Addendum to Commission A18-28
Report documents
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Addendum
Tofacitinib (rheumatoid arthritis) - Addendum to Commission A18-28
Dossier assessment
Indication:
bDMARD-naive adults with moderate to severe active rheumatoid arthritis for whom a first treatment with a bDMARD is indicated
Result of dossier assessment:
Based on the data subsequently submitted on serious infections, the added benefit is now not proven
Additional information
Federal Joint Committee (G-BA)
2018-11-07 A G-BA decision was published.
Project details
- Project no.
- A18-56
- Commission
- Commission awarded on 11.09.2018 by the Federal Joint Committee (GBA).
- Report type
- Addendum
- Status
- Commission completed
- Department/Division
- Drug Assessment
- Topic
- Muscles, bones and joints
- Note
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If the need for additional work on a project commissioned by the G-BA arises during consultations, then IQWiG presents a report in the form of an "addendum". The G-BA subsequently decides on the extent of the added benefit, thus completing the early benefit assessment.
Connected Projects
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Dossier assessment
Tofacitinib (rheumatoid arthritis) - Benefit assessment according to §35a Social Code Book V (expiry of the decision)
Status: Commission completed