Andexanet alfa

Description

CATAG has developed this draft document to facilitate and support the translation of best available evidence into practice for the use of andexanet alfa for adult patients receiving a direct factor Xa (FXa) 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 September 2023.

CATAG has developed this document, based on the review of current literature. International cost-effectiveness reviews from Canada, UK and Scotland were reviewed. The pivotal Annexa trials were reviewed and a literature review was undertaken to find studies with indirect comparisons.  An expert advisory group (EAG) was convened to review the evidence, agree on consensus statements, review drafts and approved the final document.

The draft document is being placed on the website due to the urgent need, as this medicine is currently being assessed by medicines governance committees around Australia. It is currently available for consultation by external stakeholders, and a final document will be published early December.

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

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Published date

15 November 2023

Resource type

Evidence into practice

Governance topic

High-cost medicines