[A25-141] Andexanet alfa (acute major bleeding) – Addendum to Project A25-87

Last updated 22.01.2026

Project no.:
A25-141

Commission:
Commission awarded on 12.11.2025 by the Federal Joint Committee (G-BA).

Report type:
Addendum

Status:
Commission completed

Department/Division:
Drug Assessment

Topic:
Head and nerves

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: unchanged after addendum: hint of a lesser benefit

    All other patients in the therapeutic indication: unchanged after addendum: added benefit not proven

Note:

If the need for additional work on a project commissioned by the G-BA arises during consultations, then IQWiG presents a report in the form of an "addendum". The G-BA subsequently decides on the extent of the added benefit, thus completing the early benefit assessment.

DOI:

https://doi.org/10.60584/A25-141

Federal Joint Committee (G-BA)

2025-12-18 A G-BA decision was published.

G-BA documents on this decision

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