Dossier assessment

Ravulizumab - Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A19-59
Last updated

Report documents

  1. Extract of dossier assessment

    Ravulizumab - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 471 kB, EN, PDF
  2. Dossier assessment

    Ravulizumab - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 882 kB, DE, PDF

Dossier assessment

Indication:

Adults with paroxysmal nocturnal haemoglobinuria (PNH)

Result of dossier assessment:

Added benefit neither proven for patients with haemolysis and at least one clinical symptom indicative of high disease activity nor for clinically stable patients after at least 6 months of eculizumab treatment

Project details

Project no.
A19-59
Commission
Commission awarded on 01.08.2019 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 (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.

Connected Projects

  1. Addendum

    Ravulizumab (paroxysmal nocturnal haemoglobinuria) - Addendum to Commission A19-59

    Project no.
    A19-104
    Last updated

    Status: Commission completed

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