BrexpiprazoleRexulti
Treatment of schizophrenia in adults. The submission requests listing of a new 0.5 mg tablet strength to facilitate dose titration in patients who require doses less than 1 mg.
Decision on record
- Meeting Jul 2025 Recommended Schizophrenia
Access path
- TGA registered · Rexulti
TGA label narrower than the PBS population
- Mar 2017Recommended · restricted
vs lurasidone
- Jul 2025Recommended
Comparator changed: lurasidone → currently listed strengths of brexpiprazole tablet (1…
- PBS listing · Authority Required
From the public summary
6.1 PBAC recommended the listing of new form of brexpiprazole, tablet 500 micrograms, under the same circumstances as the current PBS-listed strengths of brexpiprazole tablet.PSD · Jul 2025
6.2 The PBAC noted the potency of brexpiprazole, the highest dose being only 4 mg, and acknowledged that the 0.5 mg strength would better facilitate dose titration in patients who require a less than 1 mg dose or who require a more gradual dose escalation.PSD · Jul 2025
6.32 The submission presented a cost-minimisation analysis comparing brexpiprazole with lurasidone. The equi-effective doses were assumed to be 3.58 mg/day brexpiprazole and 80 mg/day lurasidone. This assumed dose relativity was not based on the clinical evidence comparing brexpiprazole and lurasidone. The dose of brexpiprazole (3.58 mg/day) was sourced from trial 331-13-008 while 80 mg/day of lurasidone was claimed to be a widely quoted dose.PSD · Mar 2017
Ratified Minutes– March 2017 PBAC Meeting Commercial-in-ConfidencePSD · Mar 2017
6.26 Aripiprazole The submission did not make any claim or provide any clinical evidence regarding the comparative efficacy or comparative safety of brexpiprazole compared to aripiprazole in the maintenance setting.PSD · Mar 2017
The submission described brexpiprazole as non-inferior in terms of comparative effectiveness and non-inferior in terms of comparative safety over aripiprazole in the acute setting. The clinical claim is based on two direct comparisons and one indirect comparison.PSD · Mar 2017
5.2 The PBAC noted input from individuals (2) via the Office of Health Technology Assessment Consultation Hub. The PBAC noted that while the consumer inputs received were not directly related to the requested indication, they reflected lived experiences with brexpiprazole that some individuals considered relevant to the broader context of its use. Justification of the requested listingPSD · Jul 2025
5.3 The submission noted that the TGA has only approved the use of brexpiprazole in adults and that safety and effectiveness in patients under the age of 18 years has not yet been evaluated (Appendix C). The TGA recommended starting dose for the treatment of schizophrenia in adults is 1 mg.PSD · Jul 2025
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated as the 0.5 mg strength is not expected to provide substantial or clinically relevant improvement in efficacy or reduction of toxicity over existing strengths.
The PBAC noted that its recommendation was on a cost-minimisation basis and advised that, because brexpiprazole 0.5 mg tablet is not expected to provide a substantial and clinically relevant improvement in efficacy, or reduction of toxicity, over the other listed strengths of brexpiprazole, or not expected to address a high and urgent unmet clinical need given the presence of an alternative therapy, the criteria prescribed by the National Health (Pharmaceuticals and Vaccines – Cost Recovery) Regulations 2022 for Pricing Pathway A were not met. PBAC · 2025
Decision context
PopulationAdults with schizophrenia requiring dose titration or doses less than 1 mg.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2025 | Recommended | currently listed strengths of brexpiprazole tablet (1 mg, 2 mg, 3 mg, 4 mg) | — | Cost-minimisation · Cost-minimisation |
| Mar 2017 | Recommended · restricted | lurasidone | — | RCT |
Consumer voice
Two individuals provided input via the Office of Health Technology Assessment Consultation Hub reflecting lived experiences with brexpiprazole, though the input was not directly related to the requested indication.
The PBAC noted input from individuals (2) via the Office of Health Technology Assessment Consultation Hub. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to adults requiring dose titration or doses less than 1 mg; TGA label covers all adults with schizophrenia.