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Review of Anticoagulation Therapies in Atrial Fibrillation

Page last updated: 18 December 2012

Background

On 30 September 2011 the Government announced that it would commission Emeritus Professor Lloyd Sansom AO, the former Chair of the Pharmaceutical Benefits Advisory Committee (PBAC), to inform the Government on options for improving the health outcomes of patients treated with anticoagulation therapies, including optimising the use of currently available treatments in Australia as well as the future role of newer therapies for the treatment of atrial fibrillation, such as dabigatran (Pradaxa®).

Further Background

In March 2011, the PBAC recommended that dabigatran was suitable for inclusion on the Pharmaceutical Benefits Scheme (PBS) for the prevention of stroke or embolism in certain groups of patients with atrial fibrillation.  In making their recommendation, the PBAC noted that:

a. Dabigatran represented a cost effective therapy and its use could lead to reductions in morbidity.

b. The opportunity cost to the Commonwealth of listing dabigatran would be significant.

c. Dabigatran derived its advantages over warfarin when warfarin is used sub?optimally. 

d. A number of patients who are reluctant to take warfarin because of  stringent monitoring requirements and interactions with other drugs and foods, but who should be taking oral anticoagulation, would now be treated with dabigatran and this would likely lead to additional benefits and costs not measured in the trial.

e. Low risk patients currently managed on aspirin or no treatment may be unnecessarily transferred to dabigatran.

The public summary document is available.

Since the PBAC recommendation, the Therapeutic Goods Administration issued Safety Advisory Alerts for dabigatran on 5 October and 3 November 2011, noting bleeding?related adverse event reports and advising of renal function monitoring requirements respectively.

Terms of Reference

The Terms of Reference for the Review of Anticoagulation Therapies in Atrial Fibrillation are:

a. To report on current and future options for improving the health outcomes of patients with atrial fibrillation treated with oral anticoagulants.

b. To report on modes of health system delivery which may be used to optimise the use of currently available anticoagulants.

c. To report to what extent optimisation of the use of currently available anticoagulant treatments used in patients with atrial fibrillation would improve health outcomes and at what cost.

d. To examine the future role of newer anticoagulant therapies for atrial fibrillation.

e. To report on any other matter relevant to items a to d above and on any other matters referred to it by the Minister.

Review Process

On 22 December 2011, the Commonwealth Department of Health and Ageing invited submissions to the Review of Anticoagulation Therapies in Atrial Fibrillation. The call for submissions closed on 23 February 2012. The Department received 64 submissions and the majority of these were published on the PBS website, except in cases such as where a request was made for the submission not to be published.

An Issues and Options Paper was released on 29 June 2012. The Paper brought together the issues and options relevant to the Terms of Reference that were raised in submissions to the Review, on-going literature reviews, stakeholder consultations conducted to-date and discussions of the reference group.  The Department invited affected parties and individuals to provide feedback on the Paper, including at a Stakeholder Forum which was held on 4 July 2012.  Feedback was taken into account in the report of the Review.

A reference group assisted Emeritus Professor Sansom AO in the consideration of matters arising during the Review.  The membership of the reference group consisted of experts in the fields of cardiology, haematology, geriatrics, general practice, pharmacy practice and nominees from the Consumers Health Forum and the National Stroke Foundation.

Final Report

The Report of the Review of Anticoagulation Therapies in Atrial Fibrillation is now publicly available.

The Report was current when finalised by Emeritus Professor Sansom AO in late 2012.  The Department appreciates that anticoagulation therapies in atrial fibrillation is a dynamic area with new research being released on a continual basis.

Parts of the Report have been redacted based on “commercial-in-confidence” information.

Next steps

The Report includes a number of recommendations for consideration by Government. Anticoagulation therapies in atrial fibrillation is a complex area. The Minister for Health has released a media release on the Report and the handling of the recommendations.

Should you require further information about the review, please contact PBSpostmarket@health.gov.au.