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Dossier assessment

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

Status
Status: Commission completed
Project no.
A17-18
Last updated

Report documents

  1. Extract of dossier assessment

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

    published on
    Document type
    PDF-Dokument, 522 kB, EN, PDF
    Download file : Extract of dossier assessment (PDF-Dokument, 522 kB, EN, PDF)

  2. Dossier assessment

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

    published on
    Document type
    PDF-Dokument, 828 kB, DE, PDF
    Download file : Dossier assessment (PDF-Dokument, 828 kB, DE, PDF)

Dossier assessment

Indication:

Moderate to severe rheumatoid arthritis in adult patients with insufficient response to prior treatment

Result of dossier assessment:

For 4 questions added benefit not proven. In one subgroup (patients with unfavourable prognosis pretreated once, ≤ 65 years) hint of lesser benefit versus adalimumab)

Additional information

Federal Joint Committee (G-BA)

2017-10-19 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A17-18
Commission
Commission awarded on 27.04.2017 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 (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.

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