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Dossier assessment

Tofacitinib (jPsA and pJIA) - Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A21-121
Last updated

Report documents

  1. Extract of dossier assessment

    Tofacitinib (jPsA and pJIA) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 354 kB, EN, PDF
    Download file : Extract of dossier assessment (PDF-Dokument, 354 kB, EN, PDF)

  2. Dossier assessment

    Tofacitinib (jPsA and pJIA) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 616 kB, DE, PDF
    Download file : Dossier assessment (PDF-Dokument, 616 kB, DE, PDF)

Dossier assessment

Indication:

Patients with active polyarticular juvenile idiopathic arthritis (pJIA) and juvenile psoriatic arthritis (jPsA), 2 years of age and older, who have responded inadequately to previous therapy with disease-modifying antirheumatic drugs (DMARDs)

Result of dossier assessment:
  • pJIA, inadequate response to previous therapy with conventional DMARDs (including MTX): added benefit not proven.
  • pJIA, inadequate response to previous therapy with one or several biologic DMARDs: added benefit not proven.
  • jPsA, inadequate response to previous therapy with one or several DMARDs: added benefit not proven.

Project details

Project no.
A21-121
Commission
Commission awarded on 16.09.2021 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Children's and adolescents' health
Note

After completion of the assessment by IQWiG the Federal Joint Committee (GBA) 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 GBA website.

The current version 1.1 of the Dossier assessment replaces version 1.0 published on 2022-12-15.

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