Latanoprost With Timolol MaleateAPO-LATANOPROST/TIMOLOL
Reduction of elevated intraocular pressure in patients with open-angle glaucoma and ocular hypertension who are not adequately controlled with timolol monotherapy or insufficiently responsive to prostaglandins or other intraocular pressure lowering medications.
Decision on record
- Meeting Mar 2009 Recommended Anti-glaucoma
Access path
- TGA registered · APO-LATANOPROST/TIMOLOL
TGA label narrower than the PBS population
- Jul 2005Deferred
vs unfixed combination of Latanoprost and timolol (two…
- Nov 2005Recommended · restricted
Listing: Restricted → Restricted Benefit
- Nov 2005Recommended · restricted
Listing: Restricted → Restricted Benefit
- PBS listing · Restricted
Cost-effectiveness
Cost-minimisation analysis only; no ICER calculated.
Consistent with its policy on fixed dose combination products, the PBAC recommended listing on a cost-minimisation basis, concluding that the meta-analysis of the Konstas trial and trial 004 provided a point estimate of a greater than 1.5 mmHg reduction in intra ocular pressure. PBAC · 2005
Decision context
PopulationPatients with open-angle glaucoma or ocular hypertension inadequately controlled with timolol monotherapy or insufficiently responsive to prostaglandins or other intraocular pressure lowering medications.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2005 | Recommended · restricted | unfixed combination of latanoprost and timolol (two mono-therapies used in combination) | — | RCT · IOP reduction |
| Nov 2005 | Recommended · restricted | unfixed combination of latanoprost and timolol (mono-therapies used in combination) | — | RCT · IOP |
| Jul 2005 | Deferred | unfixed combination of Latanoprost and timolol (two mono-therapies used in combination) | — | RCT · Other |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients uncontrolled on Timolol monotherapy specifically, whereas TGA label includes all insufficiently responsive to beta-blockers generally.