Dorzolamide With TimololCosdor
Treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma when concomitant therapy is appropriate.
Decision on record
- Meeting Mar 2022 Recommended Elevated intra-ocular pressure
Access path
- TGA registered · Cosdor
TGA label narrower than the PBS population
- Mar 2022Recommended
vs Cosopt
- PBS listing · Restricted
From the public summary
6.1 The PBAC recommended the listing of a new ophthalmic eye drops solution in a preservative-free (PF) multi-dose bottle, Vizo-PF Dorzolatim, under the same circumstances as the currently listed brands of dorzolamide + timolol eye drops (Cosopt and Cosdor), for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma when concomitant therapy is appropriate.PSD · Mar 2022
6.3 The PBAC noted that the TGA stated that Vizo-PF Dorzolatim is bioequivalent to both the preservative-containing and PF forms of Cosopt. The PBAC advised, under section 101(4AACD) of the National Health Act 1953, that the Vizo-PF Dorzolatim, Cosopt and Cosdor brands of dorzolamide + timolol eye drops should be considered equivalent for the purposes of substitution (i.e. ‘a’-flagged in the Schedule).PSD · Mar 2022
5.2 The PBAC noted that this item received no consumer comment. Pricing considerationPSD · Mar 2022
Cost-effectiveness
This is a Committee Secretariat submission for a bioequivalent formulation (preservative-free multi-dose bottle). No economic evaluation was conducted; the submission estimated no financial implications to PBS/RPBS.
The PBAC advised that because Vizo-PF Dorzolatim is not expected to provide a substantial and clinically relevant improvement in efficacy, or reduction of toxicity, over Cosopt and Cosdor, or not expected to address a high and urgent unmet clinical need given the presence of alternative therapies, the criteria prescribed by the National Health (Pharmaceuticals and Vaccines – Cost Recovery) Regulations 2009 for Pricing Pathway A were not met. PBAC · 2022
Decision context
PopulationPatients with elevated intraocular pressure due to ocular hypertension or open-angle glaucoma whose condition is inadequately controlled with monotherapy.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2022 | Recommended | Cosopt | — | Cost-minimisation · Cost-minimisation |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients with inadequate monotherapy control, versus TGA's broader label allowing concomitant therapy without prior monotherapy requirement.