Prednisolone With PhenylephrinePrednefrin Forte
Recommended · restricted OphthalmologyRestrictedNot applicable line
Treatment of severe eye inflammation following cataract surgery for patients who identify as Aboriginal or Torres Strait Islander.
1
Submissions
2019–19
On the record
—
ICER range
Not modelled
Cost basis
Access path
- TGA registered · Prednefrin Forte
TGA label narrower than the PBS population
- Nov 2019Recommended · restricted
vs dexamethasone and fluorometholone
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
6.1 The PBAC recommended listing prednisolone with phenylephrine as a Restricted Benefit for severe eye inflammation following cataract surgery for patients who identify as Aboriginal or Torres Strait Islander. In making its recommendation, the PBAC took into consideration, among other matters, the high clinical need of the patient population and that the listing would likely be cost neutral to Government.PSD · Nov 2019
6.2 The PBAC noted that the requested listing is consistent with the indications approved by the Therapeutic Goods Administration (TGA).PSD · Nov 2019
Consumer comments
5.3 The PBAC noted that the minor submission was put forward by the National Aboriginal Community Controlled Health Organisation (NACCHO), with letters of support from representatives of the following organisations: Allergan (the manufacturer of Prednefrin Forte) Inala Indigenous Health Service Lions Outback Vision Outback Eye Service The Royal Australian and New Zealand College of Ophthalmologists Vision 2020 IDEAS Van Partnerships LtdPSD · Nov 2019
5.4 The submission claimed that anti-inflammatory ophthalmologic treatment is routinely indicated for post cataract surgery and that this is particularly important for Aboriginal and Torres Strait Islander patients, who have a higher incidence of diabetic macula oedema when inflammation is not controlled. These complications lead to a reduction in consumer and community engagement with cataract surgery and therefore poorer health outcomes.PSD · Nov 2019
Cost-effectiveness
not-modelled — this is a minor submission (price/population extension of existing listing) with cost-minimisation analysis only; no ICER calculated
The PBAC noted that the submission estimated the listing would result in a small save to the PBS and the Secretariat estimated a small cost. PBAC · 2019
Decision context
PopulationAboriginal and Torres Strait Islander patients who have had or are scheduled for cataract surgery requiring post-operative anti-inflammatory treatment.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2019 | Recommended · restricted | dexamethasone and fluorometholone | — | Cost-minimisation · Cost-minimisation |
Similar precedents
Perfluorohexyloctane66%Dexamethasone63%Polyethylene Glycol 400 With Propylene Glycol62%Propylene Glycol60%Ciclosporin60%Cationic Ophthalmic Emulsion, Preservative Free60%Hyaluronic Acid With Polyethylene Glycol 400 With Propylene Glycol With Hydroxypropyl Guar60%Ocular Lubricants (Multiple Active Ingredients)60%
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to post-operative cataract surgery inflammation in Aboriginal/Torres Strait Islander patients; TGA label covers all severe non-infectious ocular inflammation broadly.