[A25-87] Andexanet alfa (acute major bleeding) – Benefit assessment according to §35a Social Code Book V

Last updated 01.10.2025

Project no.:
A25-87

Commission:
Commission awarded on 01.07.2025 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Topic:
Haematology

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
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.

DOI:

https://doi.org/10.60584/A25-87

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