PBAC's latest decision on Quetiapine fumarate: Recommended with restriction (2009). Considered for Maintenance treatment of bipolar I disorder, in combination with a mood stabiliser (lithium or sodium valproate), for the prevention of recurrence of manic, depressive or mixed episodes.
PBAC outcome
Recommended with restriction
Authority Required (Streamlined)
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
3
first 2007
Submissions
3
2007 → 2009
Eligible population
Maintenance treatment of bipolar I disorder, in combination with lithium or sodium valproate.
Therapy area
Mental health
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
OS | PFS | DFS | ORR | QoL | Surrogate | Cost-minimisation | Other (QoL, time to recurrence of mood event)
Key trials
Tohen et al (2004)
Comparator
olanzapine
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis conducted; no ICER calculated
Submission history
2007: Recommended with restriction · Authority required
Mar 2009: Not recommended
Mar 2009: Recommended with restriction · Authority Required (Streamlined)