PaliperidoneINVEGA
Recommended Mental healthAuthority Required 💬 consumer voice
Maintenance treatment of schizophrenia in adults.
3
Submissions
2007–25
On the record
—
ICER range
Cost-min
Cost basis
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
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
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
Economic analysis
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
Cost-effectiveness accepted ×2
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.