September 2003 PBAC Outcomes - "1st time" decisions not to recommend
1st time decisions not to recommend - September 2003 PBAC Outcomes
| Drug and form | Drug Use / Type | Listing requested by Sponsor | PBAC Outcome and Comments |
|---|---|---|---|
| FONDAPARINUX SODIUM, injection, 2.5mg in 0.5mL pre-filled syringe, Arixtra®
Sanofi-Synthelabo Australia Pty Ltd |
Fondaparinux, being a selective inhibitor of activated Factor X (Factor Xa), is an antithrombotic agent used for the prevention of venous thromboembolic events in major orthopaedic surgery | Restricted benefit listing for the prevention of venous thromboembolic events (VTE) in patients undergoing major hip surgery and in patients undergoing major knee surgery. | The PBAC rejected the submission because of issues with the clinical claim and the
resulting cost-effectiveness claim.
Sponsor's comments: The sponsor disagrees with the decision and is considering its course of action. Please refer to the Sanofi-Synthelabo website for further information on Arixtra®. Web address: |
