Quetiapine FumarateALKEM QUETIAPINE
Not recommended Mental healthAuthority Required (Streamlined)Later-line line
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.
4
Submissions
2007–09
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
- Meeting Nov 2010 Not recommended Treatment of acute mania associated with bipolar I disorder in combination with lithium or sodium valproate; Maintenance treatment of bipolar 1 disorder, as monotherapy or in combination with lithium or sodium valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes
- Meeting Jul 2010 Recommended Bipolar disorder
- Meeting Nov 2009 Recommended Bipolar disorder no PSD
- Meeting Nov 2009 Not recommended Bipolar disorder no PSD
- Meeting Nov 2009 Not recommended Bipolar disorder no PSD
- Meeting Mar 2009 Recommended Bipolar disorder
- Meeting Mar 2009 Not recommended Bipolar disorder
- Meeting Jul 2008 Recommended Schizophrenia no PSD
3 earlier decisions
- Mar 2008 Not recommended Anti-psychotic no PSD
- Jul 2007 Recommended Bipolar 1 Disorder
- Dec 2001 Recommended For schizophrenia no PSD
Access path
- TGA registered · ALKEM QUETIAPINE
TGA label narrower than the PBS population
- 2007Recommended · restricted
vs olanzapine
- Jul 2007Recommended · restricted
Evidence: RCT, indirect comparison → RCT
- Mar 2009Recommended
- Mar 2009Recommended · restricted
- PBS listing · Authority Required (Streamlined)
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
Study Active Placebo WMD (random) Weight WMD (random) or sub-category N Mean (SD) N Mean (SD) 95% CI % 95% CIPSD · 2007
Meta-analysis of YMRS response (decrease of ≥50% from baseline in YMRS total score) at Day 21, random effects model Review: Quetiapine Comparison: 01 Quetiapine vs olanzapine, indirect comparisonPSD · 2007
Comparative effectiveness
Direct Comparison Percentage of responders at Week 6 (response defined as achieving > 50% reduction in Young Mania Rating Scale (YMRS) score) Trial Percentage of responders Belenkaya et al, 2005 - Risperidone (n=15) 57% - Quetiapine (n=15) 67.8%PSD · 2007
- Olanzapine (n=15) 63.2% The percentage of responders trended towards higher levels in the quetiapine group compared to the olanzapine group (67.8% vs 63.2%, respectively) however the statistical significance of the difference was not reported. Public Summary Document July 2007 PBAC Meeting Page 2 of 6PSD · 2007
Cost-effectiveness
Cost-minimisation analysis conducted; no ICER calculated
The PBAC noted the trial data indicated that the equi-effective doses for the treatment of bipolar disorder are quetiapine 29 mg (base) for 42 days and olanzapine 1 mg for 42 days, and that the equi-effective doses for the treatment of bipolar disorder for risperidone and olanzapine are 3.75 mg per day and 10.4 mg per day. PBAC · 2007
Cost-effectiveness accepted
Decision context
PopulationMaintenance treatment of bipolar I disorder, in combination with lithium or sodium valproate.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2009 | Recommended | olanzapine | — | RCT · change in total Montgomery-Asberg Depression Rating Scale (MADRS) scores between baseline and Week 8 |
| Mar 2009 | Recommended · restricted | olanzapine | — | RCT · OS | PFS | DFS | ORR | QoL | Surrogate | Cost-minimisation | Other (QoL, time to recurrence of mood event) |
| Jul 2007 | Recommended · restricted | olanzapine | — | RCT · YMRS |
| 2007 | Recommended · restricted | olanzapine | — | RCT, indirect comparison · OS | PFS | DFS | ORR | QoL | Surrogate | Cost-minimisation | Other (QoL, surrogate measures) |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to combination therapy with mood stabilizers and later-line use; TGA permits monotherapy and earlier use.