Dabigatran given green light for AF listing

THE oral thrombin inhibitor dabigatran has been approved for listing on the PBS for use in patients with atrial fibrillation (AF) under a new pilot, fast-track regulatory process.

Dabigatran (Pradaxa) reimbursement was approved at the March meeting of the Pharmaceutical Benefits Advisory Committee (PBAC) for use in patients with AF at risk of stroke on the basis of “acceptable cost-effectiveness”.

However, TGA approval was granted only last Friday, a Health Department spokesperson confirmed. Dabigatran was one of a number of drugs approved as part of a pilot run by the department, allowing for expedited reimbursement review, a spokesman for the sponsor, Boehringer Ingelheim, said.

The approval comes as several medicines recommended by the PBAC for reimbursement have been deferred by Cabinet (MO, 28 April 2011).

“We are confident the Government will recognise the considerable unmet medical need surrounding stroke