Sertindole
Not recommended Mental healthAuthority RequiredSecond-line line
treatment of schizophrenia in people who have had prior treatment with at least one other antipsychotic
1
Submissions
2011–11
On the record
—
ICER range
Cost-min
Cost basis
Decision on record
- Meeting Mar 2011 Not recommended Schizophrenia
Cost-effectiveness
Cost minimisation analysis presented; no ICER calculated as submission compared equi-effective doses
The PBAC noted the results of the safety study 99824 showed statistically significantly higher rates of cardiac deaths (Independent Safety Committee (ISC)), and a higher rate of discontinuation of treatment in patients treated with sertindole compared to risperidone. PBAC · 2011
Immature survival data
Decision context
Populationpeople who have had prior treatment with at least one other antipsychotic
Why it was knocked back
- uncertain clinical need, concerns regarding relative efficacy (non-inferiority to olanzapine not demonstrated), cardiovascular adverse effects (statistically significantly higher rates of cardiac deaths compared to risperidone, QT interval prolongation), potential drug interactions with commonly prescribed drugs (fluoxetine, paroxetine), lack of evidence in treatment-resistant patients, high market share and availability of alternative PBS-subsidised options
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2011 | Not recommended | olanzapine | — | RCT, indirect meta-analysis · PANSS total score change from baseline |
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both restrict use to schizophrenia patients with prior antipsychotic non-response or intolerance; PBAC's 'prior treatment' operationalizes TGA's restrictive safety conditions.