Andexanet alfa

Description

CATAG created this document to facilitate and support the translation of best available evidence into practice regarding the potential use of andexanet alfa for adult patients receiving a direct factor Xa inhibitor (apixaban or rivaroxaban) presenting with severe and life-threatening bleeds. The document provides consensus statements based on the current available evidence for andexanet alfa as of May 2024.

Update (May 2026): AstraZeneca has advised that ANDEXXA® (andexanet alfa) will be discontinued in Australia effective 20 May 2026 due to commercial reasons, with provisional registration lapsing on this date; this decision is not related to any new safety, quality, or efficacy concerns.

CATAG developed this document, based on the review of literature and international cost-effectiveness reviews from Canada, UK and Scotland, up to May 2024. An expert advisory group (EAG) was convened to review the evidence, agree on consensus statements, review drafts and feedback and approve the final position statement.

This document will assist good governance and decision-making for health service organisations, Medicines and Therapeutics Committees and health professionals. It can be used in conjunction with formulary decisions and recommendations.

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Published date

11 November 2024

Resource type

Position statements

Governance topic

High-cost medicines