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Dossier assessment

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

Status
Status: Commission completed
Project no.
A18-28
Last updated

Report documents

  1. Extract of dossier assessment

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

    published on
    Document type
    PDF-Dokument, 131 kB, EN, PDF
    Download file : Extract of dossier assessment (PDF-Dokument, 131 kB, EN, PDF)

  2. Dossier assessment

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

    published on
    Document type
    PDF-Dokument, 797 kB, DE, PDF
    Download file : Dossier assessment (PDF-Dokument, 797 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:

Negative effect in serious infections; indication of lesser benefit in comparison with the comparator therapy

Project details

Project no.
A18-28
Commission
Commission awarded on 02.05.2018 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.

Connected Projects

  1. Addendum

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

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    A18-56
    Last updated

    Status: Commission completed

  2. Dossier assessment

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    A18-52
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    Status: Commission completed

  3. Dossier assessment

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    Status: Commission completed

  4. Dossier assessment

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

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    Status: Commission completed

  5. Dossier assessment

    Tofacitinib (ankylosing spondylitis) - Benefit assessment according to §35a Social Code Book V

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  6. Dossier assessment

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    Last updated

    Status: Commission completed

  7. Dossier assessment

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

    Project no.
    A21-115
    Last updated

    Status: Commission completed

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