Fluocinolone Acetonide
Diabetic macular oedema (DMO) in patients who are unsuitable for, contraindicated to, or have failed treatment with vascular endothelial growth factor (VEGF) inhibitors.
Decisions on record
- Meeting Mar 2022 Withdrawn Diabetic macular oedema no PSD
- Meeting Nov 2020 Not recommended Diabetic macular oedema
- Meeting Mar 2020 Recommended Diabetic macular oedema
Access path
- Mar 2020Recommended · restricted
vs dexamethasone intravitreal implant
- Nov 2020Not recommended
Comparator changed: dexamethasone intravitreal implant → dexamethasone (DEX) intravitreal…
From the public summary
6.1 The PBAC reaffirmed its previous recommendation from March 2020 for the Authority Required listing of fluocinolone acetonide (FA) for the treatment of diabetic macular oedema (DMO) in patients who are unsuitable for, contraindicated to, or have failed treatment with vascular endothelial growth factor (VEGF) inhibitors.PSD · Nov 2020
6.2 The PBAC noted the input from the Consumer Comments facility on the PBS website, describing a range of benefits with FA including access for suitable patients who are 12PSD · Nov 2020
5.12 The March 2020 submission presented a CMA of FA to DEX based on an indirect comparison using the randomised trials FAME and MEAD. The equi-effective doses were estimated by the Sponsor as FA 190 g 1 administration per 36 months and DEX 700 g 6.48 administrations over 36 months. The PBAC considered this dose relativity to be inappropriate because it did not reflect the clinical trial data provided in the submission.PSD · Nov 2020
5.13 The March 2020 submission claimed that patients would receive VEGF inhibitors rather than another FA implant if they require retreatment. The CMA assumed only one VEGF inhibitor injection would be received per patient (i.e. one month of treatment), which the PBAC considered may not be reasonable (paragraph 6.28, FA PSD, March 2020).PSD · Nov 2020
5.4 The March 2020 submission described FA as non-inferior in terms of effectiveness and safety compared with DEX. The minor resubmission did not update the clinical claim.PSD · Nov 2020
5.5 The PBAC previously considered that FA was non-inferior in terms of comparative efficacy to DEX, based on the indirect comparison of two pooled randomised studies for each product using sham injection as a common treatment arm (paragraph 7.4, FA PSD, March 2020). The PBAC considered that while there were transitivity and applicability issues with the indirect comparison, on balance, the claim of non-inferior effectiveness was supported.PSD · Nov 2020
5.28 In March 2020, the PBAC noted DEX has a risk sharing arrangement (RSA) with a rebate in place to account for use beyond the utilisation estimates presented in the DEX submission (paragraph 7.9, DEX PSD, March 2016). The PBAC advised that FA would be required to join the DEX RSA with no changes to the expenditure caps in order to manage any residual uncertainty regarding the financial estimates.PSD · Nov 2020
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design.
Decision context
PopulationAdults with diabetic macular oedema who have been previously treated with a course of corticosteroids without clinically significant rise in intraocular pressure, and who are unsuitable for, contraindicated to, or have failed VEGF inhibitor treatment.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2020 | Not recommended | dexamethasone (DEX) intravitreal implant | — | RCT · Visual acuity |
| Mar 2020 | Recommended · restricted | dexamethasone intravitreal implant | — | Meta-analysis · BCVA |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| FAME-001a | Ph 3 | 956 | Visual Acuity | completed |
Consumer voice
Three healthcare professionals provided input describing benefits of treatment with FA, including reduced treatment burden, decreased frequency of injections, lower infection risk, and productivity gains. They noted that a longer-lasting injection would benefit patients currently requiring monthly injections and expressed that they had been waiting for its availability in Australia.
The comments described a range of benefits of treatment with FA, including access for suitable patients who are recalcitrant to other forms of treatment. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients unsuitable for, contraindicated to, or failed VEGF inhibitors; TGA label has no such requirement.