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Dossier assessment

Marstacimab (haemophilia B) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A25-17
Last updated

Report documents

  1. Extract of dossier assessment

    Marstacimab (haemophilia B) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 301 kB, EN, not accessible
    DOI-Link
    https://doi.org/10.60584/A25-17_en
    Download file : Extract of dossier assessment (PDF document, 301 kB, EN, not accessible)

  2. Dossier assessment

    Marstacimab (haemophilia B) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 508 kB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A25-17
    Download file : Dossier assessment (PDF document, 508 kB, DE, not accessible)

Dossier assessment

Indication:

Routine prophylaxis of bleeding episodes in patients 12 years of age and older, weighing at least 35 kg, with severe haemophilia B (congenital factor IX deficiency, FIX < 1%) without factor IX inhibitors

Result of dossier assessment:

Added benefit not proven

Project details

Project no.
A25-17
Commission
Commission awarded on 03.02.2025 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Haematology
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/A25-17_en

Connected Projects

  1. Dossier assessment

    Marstacimab (haemophilia A) – Benefit assessment according to §35a Social Code Book V

    Project no.
    A25-16
    Last updated

    Status: Commission completed

  2. Dossier assessment

    Marstacimab (haemophilia B, with factor IX inhibitors) – Benefit assessment according to §35a Social Code Book V

    Project no.
    A26-56
    Last updated

    Status: Commission completed

  3. Dossier assessment

    Marstacimab (haemophilia A, with factor VIII inhibitors) – Benefit assessment according to §35a Social Code Book V

    Project no.
    A26-55
    Last updated

    Status: Commission completed

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