Dorzolamide Hydrochloride With Timolol Maleate, Eye Drops
Recommended OphthalmologyRestricted BenefitLater-line line
reduction of elevated intra-ocular pressure in patients with open-angle glaucoma or ocular hypertension that is not adequately controlled with monotherapy
1
Submissions
2012–12
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
- Meeting Jul 2012 Recommended Glaucoma and ocular hypertension
- Meeting Sep 2001 Recommended A combination product for glaucoma no PSD
Access path
- Jul 2012Recommended · restricted
vs preservative containing dorzolamide with timolol…
- PBS listing · Restricted Benefit
RecommendedDeferredNot recommended
Cost-effectiveness
Cost-minimisation analysis performed; no ICER calculated
The PBAC considered Trial P081 provided a sufficient basis to conclude that dorzolamide hydrochloride with timolol maleate eye drops (PF) are non-inferior for both efficacy and safety to dorzolamide hydrochloride with timolol maleate eye drops with preservative, in terms of lowering intra-ocular pressure and the secondary outcomes assessed in the trial. PBAC · 2012
Surrogate endpointCost-effectiveness accepted
Decision context
Populationpatients with open-angle glaucoma or ocular hypertension that is not adequately controlled with monotherapy
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2012 | Recommended · restricted | preservative containing dorzolamide with timolol (PC-dorz/tim) | — | RCT · OS | PFS | DFS | ORR | QoL | Surrogate | Cost-minimisation | Other | null |
Similar precedents
Dorzolamide With Timolol85%Travoprost With Timolol Maleate, Eye Drops82%Brinzolamide/Brimonidine Tartrate78%Bimatoprost With Timolol Maleate79%Betaxolol, Bimatoprost, Bimatoprost + Timolol, Brimonidine, Brimonidine + Timolol, Brinzolamide, Brinzolamide + Timolol, Dorzolamide, Dorzolamide + Timolol, Latanoprost, Latanoprost + Timolol, Pilocarpine, Timolol, Travoprost, Timolol + Travoprost78%Latanoprost With Timolol Maleate76%Travoprost With Timolol Maleate71%Tafluprost70%
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to inadequate monotherapy control and later-line use; TGA label permits any concomitant therapy setting.