Polyethylene Glycol 400 With Propylene Glycol
Treatment of severe dry eye syndrome. Specifically, a new 28 x 0.8 mL unit dose pack size requested on a cost-minimisation basis versus the currently listed 30-pack.
Decisions on record
- Meeting Nov 2025 Recommended Severe dry eye syndrome
- Meeting Jul 2022 Recommended Severe dry eye syndrome, including Sjogren's syndrome
- Meeting Nov 2021 Recommended Severe dry eye syndrome
- Meeting Nov 2008 Recommended Lubricant eye drop no PSD
- Meeting Jul 2008 Recommended Severe dry eye syndrome, including Sjorgen’s syndrome no PSD
Access path
- Nov 2021Recommended
vs polyethylene glycol 400 with propylene glycol eye drops, 28…
- Jul 2022Recommended · restricted
Comparator changed: polyethylene glycol 400 with propylene glycol eye drops, 28 x 0.8 mL…
- Nov 2025Recommended
Comparator changed: Systane (polyethylene glycol 400 0.4% with propylene glycol 0.3% eye…
- PBS listing · Restricted
From the public summary
6.1 The PBAC recommended listing the 28-pack at the same price per dose as proposed by the submission, under the same circumstances. The PBAC further noted that it had made recommendations at this meeting (item 9.01 refers) to alter the circumstances under which preservative-free ocular lubricant eye drops are declared pharmaceutical benefits and that these changed circumstances would apply to the listing of this new 4PSD · Nov 2025
OFFICIAL Public Summary Document– November 2025 PBAC Meeting medicinal product pack.PSD · Nov 2025
5.6 As a Category 4 submission, the economic analysis was not independently evaluated.PSD · Nov 2025
5.7 The submission presented a cost-minimisation approach of the 30-pack compared with the 28-pack, requesting the same Approved Ex-Manufacturer Price (AEMP) per dose and assuming an equi-effective dose of 1 unit to 1 unit.PSD · Nov 2025
5.3 The submission claimed non-inferior comparative effectiveness and safety to Systane. The submission did not provide any clinical evidence in support of the clinical claim. The submission highlighted that artificial tears do not require bioequivalence studies and as such, the TGA would not provide an equivalence statement for this product.PSD · Jul 2022
5.4 The submission stated that Optix is pharmaceutically equivalent to Systane as both products contain polyethylene glycol 400 0.4% and propylene glycol 0.3%.PSD · Jul 2022
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. This is a Category 4 submission (pack size formulation change) with equi-effective dosing (1:1).
The PBAC noted that its recommendation was on a cost-minimisation basis and advised that, because the 28-pack is not expected to provide a substantial and clinically relevant improvement in efficacy, or reduction of toxicity, over the lowest cost ocular lubricant, or not expected to address a high and urgent unmet clinical need given the presence of an alternative therapy, the criteria prescribed by the National Health (Pharmaceuticals and Vaccines – Cost Recovery) Regulations 2022 for Pricing Pathway A were not met. PBAC · 2025
Decision context
PopulationAdults with severe dry eye syndrome, particularly those sensitive to preservatives in multi-dose eye drops.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2025 | Recommended | Systane 30 x 0.8 mL unit dose pack | — | Cost-minimisation · Cost-minimisation |
| Jul 2022 | Recommended · restricted | Systane (polyethylene glycol 400 0.4% with propylene glycol 0.3% eye drops, 15 mL) | — | Cost-minimisation · Cost-minimisation |
| Nov 2021 | Recommended | polyethylene glycol 400 with propylene glycol eye drops, 28 x 0.8 mL unit doses | — | Cost-minimisation · Cost-minimisation |
Consumer voice
One individual with severe dry eye syndrome who uses polyethylene glycol 400 with propylene glycol described the significant impact on their everyday life including progressive vision loss, and expressed concern about the cost and accessibility of ongoing treatment as polyethylene glycol is not PBS-listed.
The individual described the significant impact of severe dry eye syndrome on their everyday life, including progressive vision loss. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — TGA label is broad 'lubricant, eye'; PBAC restricts to adults with severe dry eye syndrome, particularly preservative-sensitive patients.