Ziprasidone HydrochlorideAPO-ZIPRASIDONE
Recommended Mental healthAuthority RequiredNot applicable line
Monotherapy, for up to 6 months, of an episode of acute mania or mixed episodes associated with bipolar I disorder.
4
Submissions
2006–08
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
- Meeting Nov 2008 Recommended Bipolar disorder
- Meeting Nov 2006 Recommended Schizophrenia
Access path
- TGA registered · APO-ZIPRASIDONE
TGA label narrower than the PBS population
- Nov 2006Recommended · restricted
vs olanzapine
- Nov 2006Recommended · restricted
- Nov 2008Recommended · restricted
Evidence: RCT → RCT, Meta-analysis
- Nov 2008Recommended · restricted
Evidence: RCT → RCT, Meta-analysis
- PBS listing · Authority Required
RecommendedDeferredNot recommended
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated.
A preliminary economic evaluation was presented using a cost-minimisation approach. This was considered valid by the PBAC. PBAC · 2006
Surrogate endpointIndirect comparisonCost-effectiveness accepted ×2
Decision context
PopulationPatients with acute mania or mixed episodes associated with bipolar I disorder treated with ziprasidone monotherapy for up to 6 months.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2008 | Recommended · restricted | olanzapine | — | RCT, Meta-analysis · change from baseline in Young/Mania Rating Scale (Y/MRS) scores |
| Nov 2008 | Recommended · restricted | olanzapine | — | Meta-analysis · Y/MRS |
| Nov 2006 | Recommended · restricted | olanzapine | — | RCT · null |
| Nov 2006 | Recommended · restricted | olanzapine | — | RCT |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricted duration to 6 months maximum; TGA label specifies 'short-term' without explicit temporal limit.