PBAC's latest decision on Fluocinolone acetonide: Recommended with restriction (2020). Considered for Diabetic macular oedema (DMO) in patients who are unsuitable for, contraindicated to, or have failed treatment with vascular endothelial growth factor (VEGF) inhibitors.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
2
first 2020
Submissions
2
2020 → 2020
Eligible population
Adults 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.
Therapy area
Ophthalmology
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
Visual acuity
Pivotal trial size
727 patients
Key trials
FAME-001a, FAME-001b, MEAD-010, MEAD-011
Comparator
dexamethasone (DEX) intravitreal implant
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated by design.
Submission history
Mar 2020: Recommended with restriction · Authority Required
Nov 2020: Recommended with restriction · Authority Required