PBAC's latest decision on Cationic ophthalmic emulsion, preservative free: Recommended with restriction (2020). Considered for Treatment of severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2020
Submissions
1
2020 → 2020
Eligible population
Adults with severe dry eye syndrome who are sensitive to preservatives in multi-dose eye drops.
Therapy area
Ophthalmology
Line of therapy
Not applicable
Evidence base
RCT
Primary endpoint
Efficacy and safety (non-inferiority)
Pivotal trial size
85 patients
Key trials
NVG07F105 (Amrane 2014), NVG11F120 (Robert 2016)
Comparator
preservative-free, multi-dose ocular lubricants currently listed on the PBS (Evolve carmellose 0.5% and Evolve hypromellose 0.3%)
Economic model
Cost-minimisation
Eligible patients/year
250,000
ICER note
Cost-minimisation analysis conducted; no ICER calculated by design.