Dossier assessment

Fluticasone furoate/umeclidinium/vilanterol (COPD) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A18-15
Last updated

Report documents

  1. Extract of dossier assessment

    Fluticasone furoate/umeclidinium/vilanterol (COPD) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 289 kB, EN, PDF
  2. Dossier assessment

    Fluticasone furoate/umeclidinium/vilanterol (COPD) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 659 kB, DE, PDF

Dossier assessment

Indication:

Adults with moderate to severe COPD who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta 2 agonist

Result of dossier assessment:

No statistically significant differences between the treatment groups in the relevant subpopulation of the study included; added benefit not proven

Additional information

Federal Joint Committee (G-BA)

2018-08-16 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A18-15
Commission
Commission awarded on 27.02.2018 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

    Fluticasone furoate/umeclidinium/vilanterol (COPD) – Addendum to Commission A18-15

    Project no.
    A18-46
    Last updated

    Status: Commission completed

  2. Dossier assessment

    Fluticasone furoate/umeclidinium/vilanterol (COPD) - Benefit assessment according to §35a Social Code Book V

    Project no.
    A18-79
    Last updated

    Status: Commission completed

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