[A19-76] Andexanet alfa (acute major bleeding) - Benefit assessment according to §35a Social Code Book V

Last updated 02.12.2019

Project no.:
A19-76

Commission:
Commission awarded on 30.08.2019 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Application field:
Haematology

Indication:

Adults treated with apixaban or rivaroxaban when reversal of anticoagulation is needed due to major bleeding

Result of dossier assessment:

No comparison with appropriate comparator therapy possible; therefore added benefit currently 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.

Federal Joint Committee (G-BA)

2020-02-20 A G-BA decision was published.

G-BA documents on this decision

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