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Dabigatran PBS listing ‘imminent’

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Dabigatran PBS listing ‘imminent’

An announcement is expected within days on the long-delayed PBS listing of the novel oral anticoagulant dabigatran (Pradaxa) for patients with non-valvular atrial fibrillation, manufacturer Boehringer Ingelheim says.

Health Minister Tanya Plibersek has this week flagged that Bayer's rivaroxaban (Xarelto) will "soon be subsidised" as a treatment for the prevention of stroke in patients with atrial fibrillation.

In response, Boehringer Ingelheim said: "We understand that rivaroxaban will be PBS listed as a stroke prevention therapy for patients with non-valvular atrial fibrillation on the basis that its manufacturer submitted a lower price in order to help overcome previous rejections by the PBAC."

The company noted that dabigatran has been reviewed by the PBAC three times since March 2011 and received a positive recommendation on each occasion.

"Boehringer Ingelheim now awaits the final details from the Department of Health and Ageing to allow a listing date to be confirmed for Pradaxa.

"This information should be received in the coming days. We expect that the Department of Health and Ageing will now move quickly to provide certainty to the many patients and doctors waiting for Pradaxa," said Wes Cook, Managing Director of Boehringer Ingelheim Australia and New Zealand.

"In the meantime, the company said it would continue to support the 25,000 patients who have received Pradaxa at no cost through an early access program for the last two years."

In a statement released Monday the company said it was hopeful of a rapid decision by the Department of Health and Ageing.

Dabigatran was initially approved for PBS listing by the PBAC in 2011.

However, in an unprecedented move the department announced it would defer the listing pending a review by Professor Lloyd Samson, former head of the PBAC.

His review, finalised in late 2012, concluded that there was uncertainty about the safety, effectiveness and cost-effectiveness of newer anticoagulants.

However, a more recent PBAC evaluation in March 2013 again backed dabigatran for PBS listing.



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