Review of Anticoagulation Therapies in Atrial Fibrillation

Updated: 4 April 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 and mortality.

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 at: http://www.health.gov.au/internet/main/publishing.nsf/Content/pbac-psd-dabigatran-march11.

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.

Submissions

The Commonwealth Department of Health and Ageing invited interested parties and individuals to provide written submissions to the Review. The submission period was between 22 December 2011 and 23 February 2012.

Submissions to the Review of Anticoagulation Therapies in Atrial Fibrillation are now available.

Publication of Submissions

Unless otherwise requested by the submitter, submissions or parts of submissions, will be published on the pbs.gov.au website and some of the contents of these submissions may be included in the final Report.  Information that was provided in confidential submissions, or parts thereof, may be made available to the Reference Group, the Department of Health and Ageing, PBAC members (who are all bound by confidentiality agreements), the Minister for Health and may still be subject to access under freedom of information law or for the purpose of parliamentary process.

The final decision as to whether submissions, or parts thereof, will be published is at the discretion of the Reviewer, Emeritus Professor Lloyd Sansom.  The Reviewer will not publish submissions, or parts of submissions, that contain personal information, offensive language, potentially defamatory material or copyright infringing material.

Responsibility for copyright in submissions resides with the author(s), not with the Department of Health and Ageing.

Outline of Process

An external evaluator has been engaged to conduct a literature review and a reference group has been established to assist Emeritus Professor Sansom AO in the consideration of matters arising during the Review. 

The membership of the reference group is listed below:

• Emeritus Professor Lloyd Sansom, Chair
• Professor Emily Banks, Epidemiologist
• Dr Luke Bereznicki, Pharmacy Practice
• Professor Terry Campbell, Cardiologist
• Ms Karen Carey, Consumers Health Forum nominee
• Dr Joanne Joseph, Haematologist
• Professor David Le Couteur, Geriatrician
• Professor Richard Lindley, National Stroke Foundation nominee
• Professor Peter Macdonald, Cardiologist
• Dr Ross Maxwell, General Practitioner (rural area)

Next Steps

Submitters may be contacted by the Reviewer in order to clarify or provide further information regarding issues raised in their submission.

A draft final report will be provided to the PBAC for comment, with a final report provided to the Minister for consideration.

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