Brinzolamide/Brimonidine TartrateSimbrinza
Recommended · restricted OphthalmologyRestrictedSecond-line line
Treatment of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension whose condition is inadequately controlled with monotherapy.
1
Submissions
2015–15
On the record
—
ICER range
Cost-min
Cost basis
Access path
- TGA registered · Simbrinza
TGA label equal than the PBS population
- Jul 2015Recommended · restricted
vs brinzolamide 1% and brimonidine tartrate 0.2% administered…
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
7.1 The PBAC recommended the Restricted Benefit listing of brinzolamide + brimonidine FDC on a cost-minimisation basis against the mixed comparator of dorzolamide + timolol FDC, which is the least expensive of the currently PBS listed CAI/timolol or AA/timolol FDCs; and the individual components of brinzolamide and brimonidine, with the latter contributing 12.7% of the patient population.PSD · Jul 2015
7.2 In making this recommendation, the PBAC accepted that concomitant use of the individual components and timolol-based FDCs dorzolamide+timolol FDC, brinzolamide+timolol FDC and brimonidine+timolol FDC were appropriate comparators. The PBAC acknowledged the sponsor’s argument in the PSCR that that the prostaglandin-containing FDCs (namely with bimatoprost, latanoprost and travoprost) should not be considered potential comparators.PSD · Jul 2015
Economic analysis
6.21 The submission presented a cost-minimisation analysis comparing brinzolamide + brimonidine FDC with brinzolamide plus brimonidine used concomitantly.PSD · Jul 2015
6.22 One drop twice daily of brinzolamide 1% and brimonidine 0.2% used as a fixed dose combination was equivalent to use of one drop twice daily of brinzolamide 1% and one drop twice daily of brimonidine 0.2% used concomitantly, based on the dosing in Trial C-10-041.PSD · Jul 2015
Clinical claim
6.16 The submission described brinzolamide + brimonidine FDC as non-inferior in terms of comparative effectiveness (as measured by change from baseline IOP) and non- inferior in terms of comparative safety compared with brinzolamide + brimonidine used concomitantly (primary comparator).PSD · Jul 2015
6.17 The submission claims that the supportive Trial C-10-040 showed that brinzolamide + brimonidine FDC was superior in terms of comparative effectiveness over its individual components used as monotherapy. The submission also claimed that brinzolamide + brimonidine FDC was inferior in terms of comparative safety over brinzolamide monotherapy and non-inferior in terms of comparative safety over brimonidine monotherapy.PSD · Jul 2015
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design.
Decision context
PopulationAdults with open-angle glaucoma or ocular hypertension whose condition is inadequately controlled with monotherapy.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2015 | Recommended · restricted | brinzolamide 1% and brimonidine tartrate 0.2% administered concomitantly | — | RCT · IOP |
Similar precedents
Betaxolol, Bimatoprost, Bimatoprost + Timolol, Brimonidine, Brimonidine + Timolol, Brinzolamide, Brinzolamide + Timolol, Dorzolamide, Dorzolamide + Timolol, Latanoprost, Latanoprost + Timolol, Pilocarpine, Timolol, Travoprost, Timolol + Travoprost82%Dorzolamide With Timolol79%Travoprost With Timolol Maleate, Eye Drops79%Dorzolamide Hydrochloride With Timolol Maleate, Eye Drops78%Bimatoprost With Timolol Maleate78%Latanoprost With Timolol Maleate74%Travoprost With Timolol Maleate73%Bimatoprost69%
Regulatory · TGA
Label equal than PBS population — Both specify elevated IOP in open-angle glaucoma/ocular hypertension inadequately controlled with monotherapy in adults.