PBAC's latest decision on Lurasidone hydrochloride: Not recommended (2014). Considered for Treatment of schizophrenia in adults. Proposed for first- and second-line treatment as an alternative to current oral atypical/second generation antipsychotics.
PBAC outcome
Not recommended
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2014
Submissions
1
2014 → 2014
Eligible population
Adults with schizophrenia, including those with acute exacerbation on background of chronic schizophrenia and clinically stable outpatients with chronic schizophrenia or schizoaffective disorder
Therapy area
Mental health
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
PANSS total score
Pivotal trial size
1,567 patients
Key trials
Trial 254, Trial 231, Trial 233, Trial 234, Leucht et al 2013
Comparator
ziprasidone (main); olanzapine and quetiapine (secondary)
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis presented; ICER not applicable to cost-minimisation design
Why PBAC said no
Reasons cited in the latest PSD: non-inferiority with ziprasidone not established, fundamental limitations of trials presented, cost-minimisation approach not justified by evidence, olanzapine demonstrated statistically significantly greater efficacy in meta-analysis, three-week duration and safety focus of primary trial inadequate, equi-effective doses not reasonably derived