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Dossier assessment

Garadacimab (hereditary angioedema) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A25-41
Last updated

Report documents

  1. Extract of dossier assessment

    Garadacimab (hereditäres Angioödem) Nutzenbewertung gemäß § 35a SGB V

    published on
    Document type
    PDF document, 686 kB, EN, not accessible
    DOI-Link
    https://doi.org/10.60584/A25-41_en
    Download file : Extract of dossier assessment (PDF document, 686 kB, EN, not accessible)

  2. Dossier assessment

    Garadacimab (hereditäres Angioödem) Nutzenbewertung gemäß § 35a SGB V

    published on
    Document type
    PDF document, 987 kB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A25-41
    Download file : Dossier assessment (PDF document, 987 kB, DE, not accessible)

Dossier assessment

Indication:

For routine prevention of recurrent attacks of hereditary angioedema in adults and adolescents aged 12 years and older

Result of dossier assessment:

Hint of considerable added benefit

Press releases

Garadacimab for hereditary angioedema: hint of a considerable added benefit

An indirect comparison has shown a sharp decline in the monthly rate of attacks, as well as other advantages. However, it remains incomprehensible why drug manufacturers continue to test their drugs against placebo in this therapeutic indication.
Press release

Additional information

Federal Joint Committee (G-BA)

2025.08.21 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A25-41
Commission
Commission awarded on 03.03.2025 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
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.

DOI

https://doi.org/10.60584/A25-41_en

Connected Projects

  1. Addendum

    Garadacimab (hereditary angioedema) – Addendum to Project A25-41

    Project no.
    A25-94
    Last updated

    Status: Commission completed

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