March 2009 PBAC Outcomes - Deferrals

PDF Printable version of Deferrals made by the PBAC - March 2009 (PDF 16 KB)

DRUG AND FORM DRUG USE AND TYPE LISTING REQUESTED BY SPONSOR PBAC OUTCOME AND COMMENT
DABIGATRAN ETEXILATE MESILATE, capsules, 75 mg (base) and 110 mg (base), Pradaxa®
 
Boehringer Ingelheim Pty Limited
 
Major submission
Anticoagulant Restricted benefit listing for prevention of venous thromboembolic events (VTE) in adult patients undergoing total hip replacement surgery. The PBAC deferred its consideration of dabigatran in order to give the applicant an opportunity to compare dabigatran with rivaroxaban, another new oral therapy available for the same patient population.
Sponsor’s comments: The sponsor has no comment.