PaliperidoneINVEGA
Maintenance treatment of schizophrenia in adults.
Decisions on record
- Meeting Jul 2025 Recommended Schizophrenia
- Meeting Nov 2016 Recommended Schizophrenia no PSD
- Meeting Nov 2007 Recommended Schizophrenia (mental illness)
Access path
- TGA registered · INVEGA
TGA label equal than the PBS population
- Nov 2007Recommended
vs olanzapine
- Nov 2007Recommended · restricted
- Jul 2025Recommended
Comparator changed: olanzapine → Invega Sustenna
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended the General Schedule Authority Required (STREAMLINED) listings for a new generic brand of paliperidone monthly long-acting injection (Paljuna Monthly) in 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg strength pre-filled syringe (PFS) forms, under the same circumstances as the PBS-listed originator brand (Invega Sustenna®), for the treatment of schizophrenia.PSD · Jul 2025
6.2 The PBAC’s recommendation for listing was based on, among other matters, its assessment that the cost-effectiveness of Paljuna Monthly would be acceptable if it were cost-minimised to Invega Sustenna.PSD · Jul 2025
5.4 The submission presented estimated price reductions for paliperidone monthly injection based on weighted average disclosed prices (WADPs) under the price disclosure arrangements, using the current approved ex-manufacturer prices (AEMPs) of Invega Sustenna over the six-year period from 2026 to 2031.PSD · Jul 2025
OFFICIAL Public Summary Document – July 2025 PBAC Meeting reductions through price disclosure arrangements are not regarded as relevant inputs in the economic or financial evaluation of a generic brand listing and should therefore be excluded from such assessments.PSD · Jul 2025
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. Sponsor confirmed cost-minimisation at equivalent price per injection to Invega Sustenna.
The PBAC considered that listing Paljuna Monthly would not result in a net cost to the PBS/RPBS, as it is expected to substitute for Invega Sustenna without increasing overall market utilisation. PBAC · 2025
Decision context
PopulationAdults with schizophrenia requiring maintenance treatment with paliperidone once-monthly long-acting injection.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2025 | Recommended | Invega Sustenna | — | Cost-minimisation · Cost-minimisation |
| Nov 2007 | Recommended | olanzapine | — | RCT · Other |
| Nov 2007 | Recommended · restricted | olanzapine | — | RCT · PANSS |
Consumer voice
No consumer comments were received for this item.
The PBAC noted that no consumer comments were received for this item. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both specify maintenance treatment of schizophrenia in adults; TGA's initiation requirement is operational, not a population restriction.
Listed in law
PBS listings commencing 1 Aug 2022 were made by these 4 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 67 of 2022 | 28 Jul 2022 | Repealed | PDF ↗ |
| PB 69 of 2022 | 28 Jul 2022 | Repealed | PDF ↗ |
| PB 73 of 2022 | 28 Jul 2022 | Repealed | PDF ↗ |
| PB 77 of 2022 | 28 Jul 2022 | Repealed | PDF ↗ |