Australian review finds more work needed on new anticoagulants

A report into anticoagulation therapies released yesterday by Australian Minister for Health Tanya Plibersek found more work was needed before new oral anticoagulants (NOACs) such as Pradaxa (dabigatran), from Independent German drug major Boehringer Ingelheim, could be listed on the Pharmaceutical Benefits Scheme (PBS).

This review has highlighted that there are differences between the outcomes from clinical trials and how the medicine is used in the real world, the Minister noted. Some use of dabigatran in real world settings has been different to the clinical trial evidence presented to the Pharmaceutical Benefits Advisory Committee (PBAC) in March 2011, including: the average age of patients who are likely to use it; the dose that people are likely to use; and treatment that patients would otherwise be receiving.

Ms Plibersek said that the emerging use of this drug in practice needs to be reflected in assessing its cost-effectiveness compared with existing treatments. “Australia is a world leader in health technology assessment and we make no apology for thoroughly assessing the effectiveness and cost-effectiveness of new drugs; balancing access to new medicines while also protecting public safety,” she stressed.