Addendum

Tofacitinib (rheumatoid arthritis) - Addendum to Commission A18-28

Status
Status: Commission completed
Project no.
A18-56
Last updated

Report documents

  1. Addendum

    Tofacitinib (rheumatoid arthritis) - Addendum to Commission A18-28

    published on
    Document type
    PDF-Dokument, 122 kB, DE, PDF

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.

G-BA documents on this decision

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

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

  1. Dossier assessment

    Tofacitinib (rheumatoid arthritis) - Benefit assessment according to §35a Social Code Book V (expiry of the decision)

    Project no.
    A18-28
    Last updated

    Status: Commission completed

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