PBAC's latest decision on Ciclosporin: Recommended with restriction (2022). Considered for Chronic severe dry eye disease with keratitis in patients inadequately controlled by preservative-free artificial tears monotherapy.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
2
first 2021
Submissions
2
2021 → 2022
Eligible population
Patients with chronic severe dry eye disease with keratitis equivalent to CFS grade 4 on the modified Oxford scale and OSDI ≥23 at baseline, inadequately controlled by preservative-free artificial tears monotherapy, aged 18 years or older.
Therapy area
Ophthalmology
Line of therapy
Any
Evidence base
RCT
Primary endpoint
Surrogate
Pivotal trial size
1,200 patients
Key trials
Study 2014 (NCT02254265), Study 2016 (NCT02688556), SANSIKA, SICCANOVE
Comparator
ciclosporin 0.1% cationic emulsion (Ikervis)
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated by design.
Submission history
Mar 2021: Recommended with restriction · Authority Required
Mar 2022: Recommended with restriction · Authority Required