Cationic Ophthalmic Emulsion, Preservative Free
Recommended OphthalmologyAuthority RequiredNot applicable line
Treatment of severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops.
1
Submissions
2020–20
On the record
—
ICER range
Cost-min
Cost basis
Decision on record
- Meeting Jul 2020 Recommended Severe dry eye syndrome
Access path
- Jul 2020Recommended · restricted
vs preservative-free, multi-dose ocular lubricants currently…
- PBS listing · Authority Required
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
6.1 The PBAC recommended the Authority Required (STREAMLINED) listing of cationic ophthalmic emulsion, preservative free (Cationorm) for the treatment of severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops.PSD · Jul 2020
The PBAC’s recommendation for listing was based on, among other matters, its assessment that the cost-effectiveness of Cationorm would be acceptable on a cost- minimisation basis at the lowest cost per treatment compared with other PBS-listed preservative-free, multi-dose ocular lubricants (Evolve® carmellose 0.5% and Evolve® hypromellose 0.3%).PSD · Jul 2020
Economic analysis
5.11 A cost-minimisation approach was adopted to determine the proposed price of Cationorm against the lowest cost PBS-listed preservative-free, multi-dose eye drops, assuming that Cationorm is at least non-inferior to the current PBS-listed preservative- free ocular lubricants.PSD · Jul 2020
5.12 The submission noted the PBAC’s advice that “carmellose 0.5% and hypromellose 0.3% were recommended on the basis that the price proposed by the sponsor resulted 4PSD · Jul 2020
Clinical claim
5.9 The submission claimed non-inferior comparative effectiveness and safety of Cationorm compared with other preservative-free ocular lubricants, containing the active ingredients of polyvinyl alcohol (Refresh or Liquifilm Tears) or HS (Vismed or Hylo-Fresh).PSD · Jul 2020
5.10 The PBAC considered that the claims of non-inferior comparative effectiveness and safety were reasonable.PSD · Jul 2020
Cost-effectiveness
Cost-minimisation analysis conducted; no ICER calculated by design.
Cost-effectiveness accepted
Decision context
PopulationAdults with severe dry eye syndrome who are sensitive to preservatives in multi-dose eye drops.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2020 | Recommended · restricted | preservative-free, multi-dose ocular lubricants currently listed on the PBS (Evolve carmellose 0.5% and Evolve hypromell | — | RCT · Efficacy and safety (non-inferiority) |
Similar precedents
Carmellose Sodium; Hypromellose83%Ocular Lubricants (Multiple Active Ingredients)76%Hyaluronic Acid With Polyethylene Glycol 400 With Propylene Glycol With Hydroxypropyl Guar75%Perfluorohexyloctane73%Tsp (Tamarindus Indica Seed Polysaccharide)72%Ciclosporin71%Carmellose Sodium With Glycerol And Hyaluronic Acid70%Polyethylene Glycol 400 With Propylene Glycol70%
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to severe dry eye with preservative sensitivity; TGA label covers all dry eye regardless of severity or preservative tolerance.