PBAC's latest decision on Dabigatran etexilate mesilate: Deferred (2009). Considered for prevention of venous thromboembolic events in adult patients undergoing total hip replacement surgery.
PBAC outcome
Deferred
2009
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2009
Submissions
1
2009 → 2009
Eligible population
adult patients undergoing elective total hip replacement surgery
Therapy area
Other
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
OS | PFS | DFS | ORR | QoL | Surrogate
Pivotal trial size
3,409 patients
Key trials
RE-NOVATE
Comparator
enoxaparin 40 mg
Economic model
Cost-minimisation
ICER note
Cost minimisation analysis was presented; no ICER calculated as the submission claimed equi-effectiveness to enoxaparin