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Dossier assessment

Beclometasone/formoterol/glycopyrronium (asthma) - Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A21-18
Last updated

Report documents

  1. Extract of dossier assessment

    Beclometasone/formoterol/glycopyrronium (asthma) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 578 kB, EN, PDF
    Download file : Extract of dossier assessment (PDF-Dokument, 578 kB, EN, PDF)

  2. Dossier assessment

    Beclometasone/formoterol/glycopyrronium (asthma) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 767 kB, DE, PDF
    Download file : Dossier assessment (PDF-Dokument, 767 kB, DE, PDF)

Dossier assessment

Indication:

Adult patients with asthma whose disease is not adequately controlled with a combination of medium- or high-dose ICS and LABA, and who experienced one or more asthma exacerbations in the previous year

Result of dossier assessment:

Medium-dose ICS/LABA therapy: added benefit not proven.
High-dose ICS/LABA therapy: added benefit not proven.

Additional information

Federal Joint Committee (G-BA)

19 December 2024: The G-BA’s decision of 5 August 2021 was cancelled.

G-BA documents on this decision

Project details

Project no.
A21-18
Commission
Commission awarded on 11.02.2021 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 (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. Addendum

    Beclometasone/formoterol/glycopyrronium (asthma) - Addendum to Commission A21-18

    Project no.
    A21-85
    Last updated

    Status: Commission completed

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