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Dossier assessment

Andexanet alfa (acute major bleeding) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A25-87
Last updated

Report documents

  1. Extract of dossier assessment

    Andexanet alfa (acute major bleeding) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 552 kB, EN, not accessible
    DOI-Link
    https://doi.org/10.60584/A25-87_en
    Download file : Extract of dossier assessment (PDF document, 552 kB, EN, not accessible)

  2. Dossier assessment

    Andexanet alfa (acute major bleeding) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 761 kB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A25-87
    Download file : Dossier assessment (PDF document, 761 kB, DE, not accessible)

Dossier assessment

Indication:

Adult patients treated with a direct factor Xa inhibitor (apixaban or rivaroxaban) when reversal of anticoagulation is needed due to life-threatening or uncontrollable bleeding

Result of dossier assessment:
  • Patients with intracerebral haemorrhage: hint of a lesser benefit
  • All other patients in the therapeutic indication: added benefit not proven

Press releases

Andexanet alfa for haemorrhages: hopes not fulfilled

A comparative study conducted at the request of the EMA shows only negative effects
Press release

Additional information

Federal Joint Committee (G-BA)

2026-01-22 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A25-87
Commission
Commission awarded on 01.07.2025 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/A25-87_en

Connected Projects

  1. Dossier assessment

    Andexanet alfa (acute major bleeding) - Benefit assessment according to §35a Social Code Book V

    Project no.
    A19-76
    Last updated

    Status: Commission completed

  2. Addendum

    Andexanet alfa (acute major bleeding) – Addendum to Project A25-87

    Project no.
    A25-141
    Last updated

    Status: Commission completed

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