Dossier assessment

Dupilumab (COPD) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A24-79
Last updated

Report documents

  1. Extract of dossier assessment

    Dupilumab (COPD) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 402 kB, EN, not accessible
    DOI-Link
    https://doi.org/10.60584/A24-79_en
  2. Dossier assessment

    Dupilumab (COPD) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 739 kB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A24-79_V1.1

Dossier assessment

Indication:

Add-on maintenance treatment of adult patients with uncontrolled COPD characterized by raised blood eosinophils on a combination of an inhaled corticosteroid, a long-acting beta-2 agonist (LABA), and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if an inhaled corticosteroid is not appropriate

Result of dossier assessment:

Added benefit not proven

Additional information

Federal Joint Committee (G-BA)

2025-02-06 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A24-79
Commission
Commission awarded on 31.07.2024 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.

The current version 1.1 of the Dossier assessment replaces version 1.0 published on 2024-11-04.

DOI

https://doi.org/10.60584/A24-79_en

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