Govt defends dabigatran delay

A spokesperson for the Department of Health and Ageing told MO there were many cases where the real world safety of a medicine had changed the view about how it should be used after it had been on the market for a while.

The department highlighted the case of rofecoxib (Vioxx), which was delisted in 2004 when it was linked to an increased risk of heart attack and stroke.

It also referred to the delisting of cerivastatin (Lipobay) in 2001 and PBS restrictions put on rosiglitazone (Avandia), following a 2008 TGA review.

The Sansom review of anticoagulants, published yesterday, found the clinical benefit and cost-effectiveness of new oral anticoagulants was uncertain. It recommended the Minister for Health and Ageing ask the PBAC to review its 2011 recommendation of dabigatran.

The department said the PBAC was now “concerned about whether Pradaxa represents value for money at the price offered by the company”.