PBAC's latest decision on Lurasidone: Not recommended (2015). Considered for Treatment of schizophrenia in adults, particularly for patients not controlled satisfactorily or intolerant to other atypical antipsychotic agents, or in whom weight control and cardiometabolic issues are of concern.
PBAC outcome
Not recommended
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2015
Submissions
1
2015 → 2015
Eligible population
Adults with schizophrenia not controlled satisfactorily or intolerant to atypical antipsychotic agents such as olanzapine, quetiapine and risperidone; or those in whom weight control and cardiometabolic issues are of concern.
Therapy area
Mental health
Line of therapy
Second-line
Evidence base
Meta-analysis
Primary endpoint
PANSS
Pivotal trial size
478 patients
Key trials
Trial 231 (lurasidone vs olanzapine), Breier 2005 (ziprasidone vs olanzapine), Kane 2009 (aripiprazole vs olanzapine), Leucht 2013 (multi-treatment meta-analysis)
Comparator
ziprasidone and aripiprazole (mixed comparator)
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated. Submission based on equi-effective dosing and cost comparison.
Why PBAC said no
Reasons cited in the latest PSD: non-inferiority not established due to trial applicability concerns (acute vs maintenance settings, fixed vs flexible dosing), insufficient evidence of dose-response, concerns about exchangeability of indirect comparison trials, limitations in supporting a narrower second-line restriction that may not be implementable