[A21-121] Tofacitinib (jPsA and pJIA) - Benefit assessment according to §35a Social Code Book V

Last updated 16.02.2022

Project no.:
A21-121

Commission:
Commission awarded on 16.09.2021 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Application field:
Children's and adolescents' health

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.
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.

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

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