Dossier assessment

Ponesimod (multiple sclerosis) - Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A21-159
Last updated

Report documents

  1. Extract of dossier assessment

    Ponesimod (multiple sclerosis) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 733 kB, EN, PDF
  2. Dossier assessment

    Ponesimod (multiple sclerosis) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 1 MB, DE, PDF

Dossier assessment

Indication:

Adult patients with relapsing multiple sclerosis (RMS) with active disease who have not yet received disease-modifying therapy or adult patients with non-highly active disease pretreated with disease-modifying therapy

Result of dossier assessment:
  • Patients with Expanded Disability Status Scale (EDSS) ≤ 3.5: hint of considerable added benefit
  • Patients with EDSS > 3.5: added benefit not proven

Project details

Project no.
A21-159
Commission
Commission awarded on 02.12.2021 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Head and nerves
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.

Connected Projects

  1. Dossier assessment

    Ponesimod (multiple sclerosis) - Benefit assessment according to §35a Social Code Book V

    Project no.
    A21-83
    Last updated

    Status: Commission completed

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