Hypromellose
Treatment of severe dry eye syndrome, including Sjogren's syndrome. The product provides temporary relief of symptoms due to dry eye (e.g. burning, irritation and discomfort) and is suitable for use with contact lenses.
Decisions on record
- Meeting Jul 2021 Recommended Severe dry eye syndrome including Sjogren syndrome
- Meeting Nov 2018 Recommended Severe dry eye syndrome, including Sjogren's syndrome
- Meeting Mar 2009 Recommended Dry mouth no PSD
Access path
- Nov 2018Recommended · restricted
- Jul 2021Recommended
- PBS listing · Restricted
From the public summary
5.1 The PBAC recommended the listing of a new generic brand of hypromellose 3 mg per mL eye drops (Revive Tears), under the same circumstances as the existing PBS-listed brands, Genteal and In a Wink Moisturising, for the treatment of severe dry eye syndrome (including Sjogren’s syndrome).PSD · Jul 2021
5.2 The PBAC noted that the proposed AEMP for Revive Tears is slightly lower than the existing brands and that the Committee Secretariat submission estimated there would be a net cost saving to the PBS/RPBS over six years.PSD · Jul 2021
4.3 The submission included the ARTG certificate, ARTG record summary and product leaflet for Revive Tears. The sponsor claimed that Revive Tears is pharmaceutically equivalent to Genteal and In a Wink Moisturising. 2PSD · Jul 2021
4.4 The submission requested an approved ex-manufacturer price (AEMP) of $'''''''' and a dispensed price for maximum quantity (DPMQ) of $''''''''''. The PBAC noted that the AEMP for the existing brands is slightly higher at $2.08; the DPMQ for In a Wink Moisturising is $14.51, while Genteal has a brand price premium (DPMQ is $18.60). Estimated PBS utilisation and financial implicationsPSD · Jul 2021
4.2 The PBAC noted that this item received no consumer comments.PSD · Jul 2021
Cost-effectiveness
Cost-minimisation submission; no ICER calculated. This is a generic brand listing with estimated net cost saving to PBS/RPBS over six years.
The PBAC noted that the proposed AEMP for Revive Tears is slightly lower than the existing brands and that the Committee Secretariat submission estimated there would be a net cost saving to the PBS/RPBS over six years. PBAC · 2021
Decision context
PopulationAdults with severe dry eye syndrome, including Sjogren's syndrome, receiving treatment under a GP Management Plan or Team Care Arrangements.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2021 | Recommended | Genteal and In a Wink Moisturising (existing PBS-listed hypromellose brands) | — | Cost-minimisation · Cost-minimisation |
| Nov 2018 | Recommended · restricted | — | — | Cost-minimisation |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to severe dry eye syndrome (including Sjögren's) with specific care arrangement requirements; TGA label covers all dry eye symptoms.
Listed in law
PBS listings commencing 1 Feb 2022 were made by these 2 determinations under the National Health Act 1953. A determination covers every listing that commenced that day, so this is the legal instrument in force for the date — not a document naming this medicine. Open it and check.
| Determination | Made | Status | |
|---|---|---|---|
| PB 1 of 2022 | 27 Jan 2022 | Repealed | PDF ↗ |
| PB 2 of 2022 | 27 Jan 2022 | Repealed | PDF ↗ |