Dabigatran Etexilate MesilateAKM DABIGATRAN
Deferred CardiovascularAuthority RequiredNot applicable line
Prevention of venous thromboembolic events in adult patients undergoing total hip replacement (THR) and total knee replacement (TKR).
2
Submissions
2 resub
2009–09
On the record
—
ICER range
Cost-min
Cost basis
Decision on record
- Meeting Mar 2009 Deferred Anticoagulant
Access path
- TGA registered · AKM DABIGATRAN
TGA label narrower than the PBS population
- Mar 2009Deferred
vs enoxaparin 40 mg
- Nov 2009Recommended · restricted
Comparator changed: enoxaparin 40 mg → enoxaparin 40 mg once daily
- PBS listing · Authority Required
RecommendedDeferredNot recommended
Cost-effectiveness
Cost-minimisation analysis performed; no ICER calculated. Economic analysis based on assumption of equi-effectiveness to enoxaparin.
The PBAC accepted the cost analysis provided in the March 2009 submission, a cost-minimisation analysis on the basis that dabigatran 220 mg and dabigatran 150 mg were equi-effective to enoxaparin 40 mg, was reasonable. PBAC · 2009
Decision context
PopulationAdult patients undergoing total hip replacement or total knee replacement surgery for prevention of venous thromboembolic events.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2009 | Recommended · restricted | enoxaparin 40 mg once daily | — | RCT |
| Mar 2009 | Deferred | enoxaparin 40 mg | — | RCT · OS | PFS | DFS | ORR | QoL | Surrogate |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricted subsidy to total hip replacement only, excluding knee replacement surgery covered by the TGA label.