RisperidoneAPO-RISPERIDONE
Recommended Mental healthAuthority Required 💬 consumer voice
Prevention of relapse of schizophrenia in adults following stabilisation with oral risperidone.
10
Submissions
4 resub
2005–26
On the record
—
ICER range
Cost-min
Cost basis
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
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
The PBAC recommended the Authority required (Streamlined) listing of risperidone in-situ microparticles (ISM) 4-weekly long-acting injection (LAI) for the treatment of schizophrenia in adults for whom tolerability and effectiveness has been established with oral risperidone, on a cost-minimisation basis versus the lowest cost alternative therapy.PSD · Mar 2024
The PBAC considered that, given the availability of other LAIs for the treatment of schizophrenia in a range of doses and the limited doses available for risperidone ISM (in particular, the lack of a lower dose option), the clinical need for risperidone ISM was low.PSD · Mar 2024
Economic analysis
The submission presented a CMA of risperidone ISM to a weighted comparator of RC and PP1M. A CMA was appropriate given the claim of non-inferior efficacy and safety.PSD · Mar 2024
Table 15 describes key components and assumptions of the CMA. 19PSD · Mar 2024
Clinical claim
The submission described risperidone ISM as non-inferior in terms of efficacy and safety compared to RC and PP1M in adults with schizophrenia. The evaluation considered that this claim may be adequately supported based on the evidence presented in the submission, noting however, the following uncertainties should be considered:PSD · Mar 2024
• There was a lack of long-term data available for risperidone ISM and the RC and PP1M comparators, with the trial treatment durations being limited to 9 to 13 weeks. The PSCR stated that the results of the Open Label Extension part of the PRISMA 3 study indicated a continued therapeutic effect of risperidone ISM over a period of more than 1 year.PSD · Mar 2024
Consumer comments
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
Cost-effectiveness accepted
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
unintended consequencesoff-label usealternative medication use
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.