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Dossier assessment

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

Status
Status: Commission completed
Project no.
A18-52
Last updated

Report documents

  1. Extract of dossier assessment

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

    published on
    Document type
    PDF document, 105 kB, EN, not accessible
    Download file : Extract of dossier assessment (PDF document, 105 kB, EN, not accessible)

  2. Dossier assessment

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

    published on
    Document type
    PDF document, 309 kB, DE, not accessible
    Download file : Dossier assessment (PDF document, 309 kB, DE, not accessible)

Dossier assessment

Indication:

Adults with moderately to severely active ulcerative colitis who have had an inadequate response or were intolerant to either conventional therapy or a biologic agent

Result of dossier assessment:

Added benefit not proven due to lack of suitable study data

Project details

Project no.
A18-52
Commission
Commission awarded on 24.08.2018 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Immune system and infections
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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