LurasidoneAPO-LURASIDONE
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.
Decision on record
- Meeting Mar 2015 Recommended Schizophrenia
Access path
- TGA registered · APO-LURASIDONE
TGA label narrower than the PBS population
- Mar 2015Recommended · restricted
vs ziprasidone and aripiprazole (mixed comparator)
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the listing of lurasidone on the basis that it should be available as an Authority Required (STREAMLINED) listing on the General Schedule.PSD · Mar 2015
In making its recommendation, the PBAC considered that lurasidone should be cost- minimised to ziprasidone only.PSD · Mar 2015
6.17 The submission presented a cost minimisation analysis against the mixedPSD · Mar 2015
6.15 The resubmission described lurasidone as non-inferior in terms of comparative effectiveness and similar in terms of comparative safety over the main comparators ziprasidone and aripiprazole.PSD · Mar 2015
6.16 The indirect comparison showed the lurasidone 40mg and pooled doses (40mg and 80mg) are non-inferior to ziprasidone and aripiprazole, with the 95% CI within the MCID of 7 points on the PANSS total score. However, lurasidone 120mg did not show non-inferiority versus aripiprazole at 8 weeks or 28 weeks.PSD · Mar 2015
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. Submission based on equi-effective dosing and cost comparison.
Decision context
PopulationAdults 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.
Why it was knocked back
- 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
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2015 | Recommended · restricted | ziprasidone and aripiprazole (mixed comparator) | — | Meta-analysis · PANSS |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to second-line use in treatment-resistant or intolerant patients, versus TGA's unrestricted adult schizophrenia label.