Addendum
Andexanet alfa (acute major bleeding) – Addendum to Project A25-87
Report documents
-
Addendum
Andexanet alfa (acute major bleeding) – Addendum to Project A25-87
Dossier assessment
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
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
Additional information
Federal Joint Committee (G-BA)
2025-12-18 A G-BA decision was published.
Project details
- Project no.
- A25-141
- Commission
- Commission awarded on 12.11.2025 by the Federal Joint Committee (GBA).
- Report type
- Addendum
- Status
- Commission completed
- Department/Division
- Drug Assessment
- Topic
- Head and nerves
- Note
-
If the need for additional work on a project commissioned by the GBA arises during consultations, IQWiG submits an addendum. The subsequent decides on the extent of the added benefit concludes the early benefit assessment.
- DOI
https://doi.org/10.60584/A25-141_en
Connected Projects
-
Dossier assessment
Andexanet alfa (acute major bleeding) – Benefit assessment according to §35a Social Code Book V
Status: Commission completed