Carmellose Sodium; Hypromellose
Recommended OphthalmologyAuthority RequiredNot applicable line 💬 consumer voice
Treatment of severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops.
2
Submissions
1 resub
2018–19
On the record
—
ICER range
Cost-min
Cost basis
Decision on record
- Meeting Jul 2018 Recommended Severe dry eye syndrome no PSD
Access path
- Jul 2018Recommended · restricted
vs sodium hyaluronate (Hylo-Fresh, Hylo-Forte); lowest cost…
- Jul 2019Recommended · restricted
Comparator changed: sodium hyaluronate (Hylo-Fresh, Hylo-Forte); lowest cost ocular…
- PBS listing · Authority Required
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
6.1 The PBAC recommended the listing of carmellose (Evolve® carmellose 0.5%) and hypromellose (Evolve® hypromellose 0.3%) multi-dose preservative-free eye drops on the General Schedule as an Authority Required (STREAMLINED) listing for the treatment of severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops.PSD · Jul 2019
6.2 The PBAC recalled that in July 2018 it recommended the Authority Required (STREAMLINED) listing of carmellose (Evolve® carmellose 0.5%) and hypromellose (Evolve® hypromellose 0.3%) multi-dose preservative-free eye drops on a cost- minimisation basis to the lowest cost ocular lubricant.PSD · Jul 2019
Economic analysis
5.6 A formal economic analysis was not presented in the minor resubmission. A cost comparison of PBS-listed preservative-free ocular lubricants is presented in the table below. At the requested DPMQ of $29.61, carmellose 0.5% and hypromellose 0.3% would be less expensive than the existing single-dose preservative-free ocular lubricants on a cost per treatment basis.PSD · Jul 2019
Consumer comments
5.4 The minor resubmission also claimed that carmellose 0.5% and hypromellose 0.3% preservative-free eye drops had non-inferior efficacy compared with other PBS-listed preservative-free ocular lubricant formulations, such as perfluorohexyloctane (Nova- Tears®) and hyaluronic acid (Hylo-Fresh®/Hylo-Forte®).PSD · Jul 2019
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. No formal economic analysis presented in the minor resubmission.
The PBAC therefore advised, under Section 101(3B) of the National Health Act 1953, that carmellose 0.5% and hypromellose 0.3% should be cost-minimised against the lowest cost ocular lubricant. PBAC · 2018
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 2019 | Recommended · restricted | lowest cost multi-dose preservative-free eye drops (hyaluronic acid, perfluorohexyloctane, single-dose carmellose/hyprom | — | Cost-minimisation · Cost-minimisation |
| Jul 2018 | Recommended · restricted | sodium hyaluronate (Hylo-Fresh, Hylo-Forte); lowest cost ocular lubricant | — | Cost-minimisation · Cost-minimisation |
Consumer voice
No consumer comments were received for this item.
The PBAC noted that no consumer comments were received for this item. Consumer comments · PSD
Similar precedents
Cationic Ophthalmic Emulsion, Preservative Free83%Hyaluronic Acid With Polyethylene Glycol 400 With Propylene Glycol With Hydroxypropyl Guar80%Carmellose Sodium With Glycerol And Hyaluronic Acid80%Ocular Lubricants (Multiple Active Ingredients)81%Hypromellose78%Tsp (Tamarindus Indica Seed Polysaccharide)79%Perfluorohexyloctane76%Propylene Glycol74%
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to severe dry eye syndrome with preservative sensitivity; TGA label covers all dry eye discomfort without these qualifiers.