[ A21-159] Ponesimod (multiple sclerosis) - Benefit assessment according to §35a Social Code Book V

Last updated 01.03.2022

Project no.:
A21-159

Commission:
Commission awarded on 02.12.2021 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Application field:
Head and nerves

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
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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