Dabigatran approved for initial PBS 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 today, a Health Department