← The record

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

1 submission · public record
  1. TGA registered · Prednefrin Forte

    TGA label narrower than the PBS population

  2. Nov 2019
    Recommended · restricted

    vs dexamethasone and fluorometholone

  3. PBS listing · Restricted
RecommendedDeferredNot recommended

From the public summary

Verbatim · PSD text · may span indications
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

1 entries
DecidedOutcomeComparatorICEREvidence
Nov 2019 Recommended · restricted dexamethasone and fluorometholone Cost-minimisation · Cost-minimisation

Similar precedents

By decision profile

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.