PBAC's latest decision on Sertindole: Not recommended (2011). Considered for treatment of schizophrenia in people who have had prior treatment with at least one other antipsychotic.
PBAC outcome
Not recommended
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2011
Submissions
1
2011 → 2011
Eligible population
people who have had prior treatment with at least one other antipsychotic
Therapy area
Mental health
Line of therapy
Second-line
Evidence base
RCT, indirect meta-analysis
Primary endpoint
PANSS total score change from baseline
Key trials
M95-372, 97203, 11286, 99824
Comparator
olanzapine
Economic model
Cost-minimisation
ICER note
Cost minimisation analysis presented; no ICER calculated as submission compared equi-effective doses
Why PBAC said no
Reasons cited in the latest PSD: 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