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Thursday, 9 February 2012
Page: 730

Pharmaceutical Benefits Scheme: Pradaxa

(Question No. 746)

Mr Alexander asked the Minister for Health and Ageing, in writing, on 22 November 2011:

(1) Is she aware that approximately 300,000 Australians at risk of severe and disabling stroke would benefit greatly from the listing of the medicine dabigatran (Pradaxa®) on the Pharmaceutical Benefits Scheme (PBS); if so, why is she deferring the listing of Pradaxa on the PBS.

(2) Why has she called for another inquiry into the efficacy of Pradaxa when similar work has already been performed and the drug approved for listing by the Pharmaceutical Benefits Advisory Committee.

(3) Will she provide a detailed breakdown for the basis of her claim in her press release from 30 September 2011 that listing Pradaxa on the PBS 'will cost the budget up to $1 billion over the forward estimates.'

Ms Plibersek: The answer to the honourable member's question asked of the former Minister for Health and Ageing is as follows:

(1) and (2) Dabigatran (Pradaxa®) is currently listed on the Pharmaceutical Benefits Scheme (PBS) for the prevention of venous thromboembolism in patients undergoing total hip or knee replacements.

At its March 2011 meeting, the Pharmaceutical Benefits Advisory Committee (PBAC) recommended extending the current PBS listing of Pradaxa to include the prevention of stroke or systemic embolism in patients with non-valvular atrial fibrillation (a condition associated with an abnormal heart rhythm).

However, in recommending the listing of PRADAXA on the PBS for patients at risk of stroke because they have atrial fibrillation, the PBAC noted the following:

PRADAXA derives its advantage over warfarin when warfarin is used sub-optimally;

improving the use of warfarin by means of an education campaign aimed at prescribers, pharmacists and patients would be less costly;

the benefit of PRADAXA observed in the clinical trial may or may not be wholly reflected in the Australian population;

a number of patients who are reluctant to take warfarin because of its stringent monitoring requirements and interactions with other drugs and foods may be treated with PRADAXA. This would likely lead to additional benefits and costs not measured in the trial;

low risk patients currently managed on aspirin may be inappropriately transferred to PRADAXA; and

listing PRADAXA would cost the budget up to $1 billion over the forward estimates.

The Government has not deferred the extension to the listing of Pradaxa, but based on the PBAC's advice, the Government has decided to seek more information about how Pradaxa would fit into the current treatment options of Australian patients at risk of stroke.

Emeritus Professor Lloyd Sansom AO, the former Chair of the PBAC, has been commissioned to review options for improving the health outcomes of patients treated with anticoagulation therapies.

This review will consider how current treatments are used and what should be the role of newer therapies for the treatment of atrial fibrillation, such as Pradaxa.

Unlike warfarin, where bleeding associated with the use of the drug can be quickly reversed with vitamin K, this solution is not available to treat bleeding associated with Pradaxa, and so it is more difficult to manage.

The Therapeutic Goods Administration has already issued two safety advisory alerts regarding Pradaxa based on the increase in bleeding-related adverse events reports and new requirements for kidney function monitoring. The review being undertaken by Professor Sansom will take all these issues into account to ensure anticoagulant therapy in Australia delivers optimal health outcomes for all patients.

Terms of Reference for the review are available on the Department's website at pbs.gov.au.

(3) Details of the Minister for Health and Ageing's Submission to the Cabinet in relation to the proposed extension to the listing of this medicine on the PBS are Cabinet-In-Confidence.

In addition, the detailed costing of the proposed extension to the PBS listing of Pradaxa contains Commercial-in-Confidence information.