Dossier assessment

Benralizumab (asthma) - Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A18-11
Last updated

Report documents

  1. Extract of dossier assessment

    Benralizumab (asthma) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 246 kB, EN, PDF
  2. Dossier assessment

    Benralizumab (asthma) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 492 kB, DE, PDF

Dossier assessment

Indication:

Add-on maintenance treatment in adults with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting beta agonists

Result of dossier assessment:

Added benefit not proven due to lack of suitable study data

Additional information

Federal Joint Committee (G-BA)

2018-08-02 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A18-11
Commission
Commission awarded on 15.02.2018 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Airways and respiratory system
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

    Benralizumab (asthma) - Addendum to Commission A18-11

    Project no.
    A18-42
    Last updated

    Status: Commission completed

  2. Dossier assessment

    Benralizumab (eosinophilic granulomatosis with polyangiitis) – Benefit assessment according to §35a Social Code Book V

    Project no.
    A24-113
    Last updated

    Status: Commission completed

  3. Dossier assessment

    Benralizumab (hypereosinophilic syndrome) – Benefit assessment according to §35a Social Code Book V

    Project no.
    A26-87
    Last updated

    Status: Commission completed

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