Anticoagulant, Pradaxa (dabigatran) will be PBS listed from 1 September 2013, it has been confirmed, two and a half years after it was first recommended.
The decision to list the drug for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation came two and a half years after the Pharmaceutical Benefits Advisory Committee (PBAC) initially recommended it.
Associate Professor John Amerena, a cardiologist at Geelong Hospital, said the decision represented a “new era in atrial fibrillation-related stroke prevention”.
“Atrial fibrillation patients will now have access to a therapy that has been rigorously tested and widely used overseas to prevent strokes over the last few years,” he said.
Welcoming the decision to list the drug, Wes Cook, managing director of Boehringer Ingelheim Australia and NewZealand, said the 25,000 patients involved in the company’s Pradaxa “familiarisation program”, would continue to have free access to the drug, until 1 September, when they will be able to have their prescriptions filled through the PBS.
As previously reported, Pradaxa 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 Pradaxa for PBS listing.