RisperidoneAPO-RISPERIDONE
Prevention of relapse of schizophrenia in adults following stabilisation with oral risperidone.
Decisions on record
- Meeting Mar 2026 Recommended Schizophrenia
- Meeting Mar 2024 Recommended Schizophrenia
- Meeting Mar 2023 Noted Schizophrenia no PSD
- Meeting Aug 2019 Noted Behavioural and psychological symptoms of dementia (BPSD)
- Meeting Nov 2015 Recommended Behavioural disturbances in patients with dementia
- Meeting Mar 2011 Recommended Bipolar disorder
- Meeting Nov 2009 Recommended Anti-psychotic drug no PSD
- Meeting Nov 2008 Recommended Behavioural disturbance no PSD
3 earlier decisions
- Jul 2008 Recommended Antipsychotic (behavioural disturbances) no PSD
- Nov 2006 Recommended Behavioural disturbances associated with autism
- Jul 2004 Recommended Used for the treatment of schizophrenia. no PSD
Access path
- TGA registered · APO-RISPERIDONE
TGA label equal than the PBS population
- Jul 2005Recommended
- Nov 2005Recommended
Evidence: Other → RCT
- Nov 2005Recommended · restricted
Evidence: Other → RCT
- Mar 2006Not recommended
not convinced that availability under section 100 would address claimed problems with patient access, submitted survey…
- ↻ resubmittedNov 2006Recommended · restricted
- Mar 2011Recommended · restricted
Comparator changed: placebo → olanzapine
- Nov 2015Recommended
Listing: Authority Required (STREAMLINED) → Restricted
- Aug 2019Recommended · restricted
Evidence: RCT → Registry
- Mar 2024Recommended · restricted
Evidence: Registry → RCT
- Mar 2026Recommended · restricted
Comparator changed: risperidone 2-weekly LAI (Risperdal Consta) and paliperidone…
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the listing of MRSC risperidone for the treatment of adult patients with schizophrenia on a cost-minimisation basis to the lowest cost long-acting injection antipsychotic (of risperidone, paliperidone or aripiprazole).PSD · Mar 2026
7.2 The PBAC considered that the primary comparators, PP1M and A1M, were appropriate. The PBAC considered the submission’s claim of non‑inferior comparative effectiveness and safety of MRSC risperidone to the comparators to be reasonable, despite the identified transitivity limitations within the comparative evidence base.PSD · Mar 2026
6.81 The submission presented a cost minimisation approach to the lowest cost alternative.PSD · Mar 2026
The submission considered that all PBS-listed antipsychotic LAIs for the treatment of schizophrenia, except olanzapine, could replace MRSC risperidone in practice and therefore would be alternative therapies .PSD · Mar 2026
6.78 The submission described MRSC risperidone as non-inferior in terms of effectiveness compared to PP1M, A1M, R2WIM, and R4WIM. The evaluation considered that the claim regarding paliperidone and aripiprazole was not convincingly supported because of concerns about the transitivity assumptions underlying the ITC but was probably 25 OFFICIALPSD · Mar 2026
OFFICIAL Public Summary Document – March 2026 PBAC Meeting reasonable given the duration and extent of clinical experience with these medications. The evaluation further noted that no evidence to support the claim regarding non-inferiority to R2WIM and R4WIM was presented, but considered the claim is probably reasonable.PSD · Mar 2026
4.2 The PBAC noted and welcomed the input from a health care professional via the Consumer Comments facility on the PBS website. The comment described the possible negative unintended consequences of the change to listing, including the increased prescribing of alternative antipsychotics, benzodiazepines or anticonvulsants, and increased off label use of risperidone. 2PSD · Nov 2015
Cost-effectiveness
Cost-minimisation analysis; no numeric ICER calculated. Submission presented cost-minimisation approach with pricing redacted.
The PBAC noted that the intent of the proposed restriction changes for risperidone is to reduce inappropriate prescribing in patients beyond 12 weeks. PBAC · 2019
Decision context
PopulationAdult patients with schizophrenia, typically following stabilisation with oral risperidone.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2026 | Recommended · restricted | paliperidone 1-monthly intramuscular injection (PP1M) and aripiprazole 1-monthly intramuscular injection (A1M) | — | RCT |
| Mar 2024 | Recommended · restricted | risperidone 2-weekly LAI (Risperdal Consta) and paliperidone 1-monthly LAI (Invega Sustenna) | — | RCT · PANSS |
| Aug 2019 | Recommended · restricted | — | — | Registry |
| Nov 2015 | Recommended | — | — | RCT |
| Mar 2011 | Recommended · restricted | olanzapine | — | RCT · time to relapse of mood episode |
| Nov 2006 | Recommended · restricted | placebo | — | RCT · Other |
| Mar 2006 | Not recommended | — | — | — |
| Nov 2005 | Recommended | olanzapine | — | RCT · QoL |
| Nov 2005 | Recommended · restricted | olanzapine | — | RCT · YMRS |
| Jul 2005 | Recommended | — | — | Other |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| PRISMA-3 | Ph 3 | 438 | PANSS Total Score Mean Change From Baseline to Endpoint | completed |
Consumer voice
A health care professional raised concerns about potential negative unintended consequences of the listing change, including increased prescribing of alternative antipsychotics, benzodiazepines, anticonvulsants, and increased off-label use of risperidone.
The comment described the possible negative unintended consequences of the change to listing, including the increased prescribing of alternative antipsychotics, benzodiazepines or anticonvulsants, and increased off label use of risperidone. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both TGA and PBAC indications identically specify schizophrenia in adults with established tolerability and effectiveness with oral risperidone.
Listed in law
PBS listings commencing 1 Jan 2025 were made by these 3 determinations under the National Health Act 1953. A determination covers every listing that commenced that day, so this is the legal instrument in force for the date — not a document naming this medicine. Open it and check.
| Determination | Made | Status | |
|---|---|---|---|
| PB 138 of 2024 | 19 Dec 2024 | Repealed | PDF ↗ |
| PB 139 of 2024 | 19 Dec 2024 | Repealed | PDF ↗ |
| PB 140 of 2024 | 19 Dec 2024 | Repealed | PDF ↗ |