Lurasidone HydrochlorideAPO-LURASIDONE
Treatment of schizophrenia in adults. Proposed for first- and second-line treatment as an alternative to current oral atypical/second generation antipsychotics.
Decision on record
- Meeting Mar 2014 Not recommended Latuda® Dainippon Sumitomo Pharma Ltd Schizophrenia To request Authority Required (STREAMLINED) General Schedule listing for the treatment of schizophrenia. Overall, the PBAC did not consider that the clinical data provided in the submission, or identified during the evaluation (Luecht et al) establ
Access path
- TGA registered · APO-LURASIDONE
TGA label narrower than the PBS population
- Mar 2014Not recommended
non-inferiority with ziprasidone not established, fundamental limitations of trials presented, cost-minimisation…
Cost-effectiveness
Cost-minimisation analysis presented; ICER not applicable to cost-minimisation design
The PBAC considered that the derivation of the equi-effective doses of lurasidone and ziprasidone from the fixed dose, short-duration, safety Trial 254 was not reasonable. PBAC · 2014
Decision context
PopulationAdults with schizophrenia, including those with acute exacerbation on background of chronic schizophrenia and clinically stable outpatients with chronic schizophrenia or schizoaffective disorder
Why it was knocked back
- 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
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2014 | Not recommended | ziprasidone (main); olanzapine and quetiapine (secondary) | — | RCT · PANSS total score |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC specifies first-line positioning and includes schizoaffective disorder; TGA label is broader, covering all schizophrenia adults without line/disorder restrictions.