Travoprost With Timolol MaleateDuoTrav
Reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension for whom a single agent therapy provides insufficient intraocular pressure reduction.
Decisions on record
- Meeting Mar 2009 Recommended Anti-glaucoma
- Meeting Mar 2007 Recommended Glaucoma
Access path
- TGA registered · DuoTrav
TGA label narrower than the PBS population
- Nov 2005Recommended
Comparator changed: concomitant travoprost 0.004% instilled once daily in the evening and…
- Nov 2005Recommended
Comparator changed: concomitant travoprost 0.004% instilled once daily in the evening and…
- PBS listing
Cost-effectiveness
cost-minimisation approach attempted but not accepted by PBAC; no economic evaluation modelled
The choice of the cost-minimisation approach was not appropriate as the PBAC considered that the evidence did not convincingly demonstrate that Extravan was non-inferior to concomitant travoprost and timolol. PBAC · 2005
Decision context
Populationpatients with open angle glaucoma or ocular hypertension not adequately controlled with either a beta-blocker or a prostaglandin as monotherapy
Why it was knocked back
- evidence does not convincingly demonstrate additive beneficial effectiveness over travoprost component, or non-inferiority to concomitant travoprost and timolol; non-inferiority criteria not met at all pre-specified time points; uncertainty about superiority claims; appropriate comparator (concomitant travoprost od pm with timolol bd) was not tested
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2005 | Recommended | concomitant travoprost 0.004% instilled once daily in the evening and timolol maleate 0.5% instilled twice daily | — | RCT · IOP reduction |
| Nov 2005 | Recommended | concomitant travoprost and timolol maleate, and travoprost or timolol maleate monotherapy | — | RCT · IOP |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients inadequately controlled with beta-blocker or prostaglandin; TGA label includes all patients with insufficient single-agent control.