Carmellose Sodium With Glycerol And Hyaluronic Acid
Noted OphthalmologyRestrictedNot applicable line
Treatment of severe dry eye syndrome.
1
Submissions
2023–23
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
- Meeting Jul 2025 Noted Severe dry eye syndrome no PSD
- Meeting May 2023 Recommended Severe dry eye syndrome
Access path
- May 2023Recommended
vs hyaluronate sodium 0.1%
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
6.1 The PBAC deferred making a recommendation to list CGH for the treatment of severe dry eye syndrome to undertake further analysis of the cost effectiveness of ocular lubricants in Australia.PSD · May 2023
6.2 The PBAC recalled that in its July 2020 consideration of Cationorm it considered the cost minimisation comparison of Hyaluronate 0.1/0.2% to Cationorm was appropriate, advising that “all preservative free, multi-dose ocular lubricants currently listed on the PBS were appropriate comparators for Cationorm” (paragraph 6.2, Cationorm PSD, July 2020 PBAC Meeting).PSD · May 2023
Economic analysis
5.14 The submission did not provide a cost-minimisation approach or an equi-effective dose. If the PBAC accepts non-inferiority based on the results of the Labetoulle study then it is reasonable to conclude that one drop of CGH is equivalent to one drop of HS 0.18%, and therefore by extension, one drop of HS 0.1%.PSD · May 2023
5.15 The submission proposed an AEMP of $16.46 for CGH and a DPMQ of $29.84.PSD · May 2023
Clinical claim
5.12 The submission claimed the non-inferior comparative effectiveness and non-inferior comparative safety of CGH compared with HS 0.1%.PSD · May 2023
5.13 The PBAC considered that the claim of non-inferior comparative effectiveness and non-inferior comparative safety was reasonably supported by the data.PSD · May 2023
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. Submission did not provide cost-minimisation approach or equi-effective dose analysis.
Economic model disputed
Decision context
PopulationPatients with severe dry eye syndrome (including moderate to severe dry eye in the trial population).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| May 2023 | Recommended | hyaluronate sodium 0.1% | — | RCT · Change in Global Ocular Staining Score (GOSS) from baseline at day 35 |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| NCT02117687 (Labetoulle 2017) | Ph 4 | 80 | Change From Baseline in Global Ocular Staining Score in the Study Eye | completed |
Similar precedents
Carmellose Sodium; Hypromellose80%Hypromellose76%Hyaluronic Acid With Polyethylene Glycol 400 With Propylene Glycol With Hydroxypropyl Guar74%Propylene Glycol74%Polyethylene Glycol 400 With Propylene Glycol71%Cationic Ophthalmic Emulsion, Preservative Free70%Ocular Lubricants (Multiple Active Ingredients)70%Perfluorohexyloctane68%
Regulatory · TGA
Label equal than PBS population — Both TGA label and PBAC recommendation specify treatment of severe dry eye syndrome with identical indication scope.