BimatoprostBimatoprost Sandoz
Noted OphthalmologyUnrestrictedFirst-line line
For the reduction of elevated intraocular pressure, or open angle glaucoma, as first line therapy or monotherapy or as adjunctive therapy to topical beta-blockers.
1
Submissions
2020–20
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
- Meeting Jul 2022 Noted Elevated intraocular pressure or open angle glaucoma no PSD
- Meeting Jul 2020 Recommended Reduction of elevated intraocular pressure or open angle glaucoma, as first-line therapy or monotherapy or as adjunctive therapy to topical beta-blockers.
- Meeting Mar 2014 Recommended Ganfort PF® Allergan Australia Pty Ltd Glaucoma To request listing of a new preservative free formulation as a restricted benefit within the general and optometrist schedules for the treatment of glaucoma. In making this recommendation, the PBAC noted it could only recommend listing of bimatoprost + no PSD
- Meeting Nov 2013 Recommended 0.03% eye drops, preservative free, 30 x 0.4 mL unit doses Lumigan® PF Allergan Pty Ltd Minor submission Glaucoma Unrestricted benefit listing within the General Schedule and Optometrist Schedule of a preservative free, unit dose presentation of bimatoprost eye drops In making this recommendation, t no PSD
- Meeting Sep 2002 Recommended An eye drop for glaucoma no PSD
Access path
- TGA registered · Bimatoprost Sandoz
TGA label equal than the PBS population
- Jul 2020Recommended
vs latanoprost (lowest priced alternative agent)
- PBS listing · Unrestricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
6.1 The PBAC recommended the listing of a new form of bimatoprost 300 microgram per mL eye drops (Vizo-PF Bimatoprost) in a preservative-free multi-dose bottle as an unrestricted benefit on a cost minimisation basis against the lowest priced alternative agent (latanoprost).PSD · Jul 2020
6.2 Vizo-PF Bimatoprost is considered bioequivalent to the PBS-listed Lumigan PF by the TGA. While the minor submission nominated Lumigan PF as the main comparator, the 6PSD · Jul 2020
Economic analysis
5.7 The minor submission presented a cost-minimisation analysis of Vizo-PF Bimatoprost compared with Lumigan PF. The equi-effective doses were estimated as Vizo-PF Bimatoprost one drop per eye per day and Lumigan PF one drop per eye (one ampoule) per day.PSD · Jul 2020
5.8 The proposed ex-manufacturer price (AEMP) for one 3 mL bottle of Vizo-PF Bimatoprost is $'''''''''' (cost per treatment per pack $'''''''''''' x 28 (total number of treatment both eyes per pack)). The proposed price of Vizo-PF Bimatoprost, as requested by the Sponsor, and the price of the comparator are presented in Table 2.PSD · Jul 2020
Clinical claim
5.3 The TGA considered that Vizo-PF Bimatoprost is bioequivalent to Lumigan PF. Vizo-PF Bimatoprost and Lumigan PF are both preservative-free, with the only difference being Vizo-PF Bimatoprost comes in a multi-dose bottle compared to single dose ampoules for Lumigan PF.PSD · Jul 2020
5.4 The submission claimed Vizo-PF Bimatoprost is non-inferior and equivalent to eye drops containing bimatoprost with preservative (Lumigan) in its ability to reduce intraocular pressure, with a similar safety profile. The submission did not define Lumigan (with preservative) as a relevant comparator, nor did it present evidence to support this claim, but provided a reference to a published study.1PSD · Jul 2020
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. All pricing and financial data are redacted (marked with quotation marks in the document).
Cost-effectiveness accepted
Decision context
PopulationPatients requiring treatment for elevated intraocular pressure or open angle glaucoma, suitable for first-line therapy, monotherapy, or adjunctive therapy to topical beta-blockers.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2020 | Recommended | latanoprost (lowest priced alternative agent) | — | Cost-minimisation · Cost-minimisation |
Similar precedents
Dorzolamide With Timolol78%Bimatoprost With Timolol Maleate77%Betaxolol, Bimatoprost, Bimatoprost + Timolol, Brimonidine, Brimonidine + Timolol, Brinzolamide, Brinzolamide + Timolol, Dorzolamide, Dorzolamide + Timolol, Latanoprost, Latanoprost + Timolol, Pilocarpine, Timolol, Travoprost, Timolol + Travoprost72%Travoprost With Timolol Maleate, Eye Drops69%Latanoprost With Timolol Maleate69%Brinzolamide/Brimonidine Tartrate69%Tafluprost69%Travoprost With Timolol Maleate64%
Regulatory · TGA
Label equal than PBS population — Both texts specify identical indications: elevated intraocular pressure or open angle glaucoma as first-line, monotherapy, or adjunctive therapy.