PBAC's latest decision on Paliperidone palmitate: Recommended with restriction (2022). Considered for Maintenance treatment of schizophrenia in adult patients who have been adequately treated with paliperidone palmitate 1-month or 3-month injectable product.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
3
first 2010
Submissions
3
2010 → 2022
Eligible population
Adult patients with schizophrenia who have been adequately treated and stabilised on paliperidone palmitate 1-month injection for at least four months or paliperidone palmitate 3-month injection for at least one 3-month injection cycle.
Therapy area
Mental health
Line of therapy
Any
Evidence base
RCT
Primary endpoint
PFS
Pivotal trial size
702 patients
Key trials
PSY3015
Comparator
paliperidone palmitate 3-month (PP3M)
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis — no ICER calculated by design. Effectiveness and safety assumed non-inferior; direct medicine costs equivalent over 48 weeks.
Submission history
Nov 2010: Recommended · Authority Required (Streamlined)
Nov 2016: Recommended with restriction · Authority Required
Mar 2022: Recommended with restriction · Authority Required