Dossier assessment

Ravulizumab (atypical haemolytic uraemic syndrome) - Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A20-68
Last updated

Report documents

  1. Extract of dossier assessment

    Ravulizumab (atypical haemolytic uraemic syndrome) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 415 kB, EN, PDF
  2. Dossier assessment

    Ravulizumab (atypical haemolytic uraemic syndrome) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 514 kB, DE, PDF

Dossier assessment

Indication:

Patients with atypical haemolytic uraemic syndrome who weigh at least 10 kg and are complement inhibitor treatment-naive or have received eculizumab for at least 3 months and have responded to this drug

Result of dossier assessment:

Added benefit not proven due to a lack of suitable study data

Project details

Project no.
A20-68
Commission
Commission awarded on 28.07.2020 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Haematology
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.

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