Paliperidone PalmitateINVEGA HAFYERA
Maintenance treatment of schizophrenia in adult patients who have been adequately treated with paliperidone palmitate 1-month or 3-month injectable product.
Decisions on record
- Meeting Mar 2022 Recommended Schizophrenia
- Meeting Nov 2010 Recommended Schizophrenia
Access path
- TGA registered · INVEGA HAFYERA
TGA label equal than the PBS population
- Nov 2010Recommended
vs risperidone modified release injection
- Nov 2016Recommended · restricted
Comparator changed: risperidone modified release injection → paliperidone one month LAI
- Mar 2022Recommended · restricted
Comparator changed: paliperidone one month LAI → paliperidone palmitate 3-month (PP3M)
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the Authority Required (Streamlined) listing of PP6M for the maintenance treatment of schizophrenia in adult patients who have been adequately treated with PP1M for at least four months or PP3M for at least one 3-month injection cycle.PSD · Mar 2022
7.2 The PBAC considered the equi-effective doses to be 1 injection of PP6M 700 mg = 2 injections of PP3M 350 mg and 1 injection of PP6M 1000 mg = 2 injections of PP3M 525 mg over 48 weeks. The PBAC noted that the equi-effective doses used in the cost- minimisation analysis were taken from results of the double-blind phase of the PSY3015 trial and were consistent with the doses in the approved PI.PSD · Mar 2022
6.23 The submission presented a cost-minimisation analysis. The key assumptions and components of the cost-minimisation approach are summarised in the table below.PSD · Mar 2022
6.24 The equi-effective doses were estimated as 1 injection of PP6M 700 mg = 2 injections of PP3M 350 mg and 1 injection of PP6M 1000 mg = 2 injections of PP3M 525 mg over 48 weeks. The equi-effective doses used in the cost-minimisation analysis were taken from results of the double-blind phase of the PSY3015 trial and are consistent with the draft PI.PSD · Mar 2022
6.19 The submission described PP6M as non-inferior in terms of effectiveness and safety compared with PP3M.PSD · Mar 2022
6.20 The evaluation noted that as the PBAC has already accepted the non-inferiority of PP3M and PP1M, it would be reasonable to extend the equivalence to included PP6M. The PBAC agreed with the evaluation.PSD · Mar 2022
6.2 The PBAC noted and welcomed the input from individuals (2) and organisations (1) via the Consumer Comments facility on the PBS website. The comments described how long-acting antipsychotics have resulted in benefits for patients including greater treatment stability, fewer visits to the doctor, and shifting the treatment focus from compliance to the improving of quality of life and pursuing goals such as stable employment.PSD · Mar 2022
Cost-effectiveness
Cost-minimisation analysis — no ICER calculated by design. Effectiveness and safety assumed non-inferior; direct medicine costs equivalent over 48 weeks.
The PBAC considered that the claim of non-inferior comparative effectiveness was reasonable. PBAC · 2016
Decision context
PopulationAdult patients with schizophrenia who have been adequately treated and stabilised on paliperidone palmitate 1-month injection for at least four months or paliperidone palmitate 3-month injection for at least one 3-month injection cycle.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2022 | Recommended · restricted | paliperidone palmitate 3-month (PP3M) | — | RCT · PFS |
| Nov 2016 | Recommended · restricted | paliperidone one month LAI | — | RCT · PFS |
| Nov 2010 | Recommended | risperidone modified release injection | — | RCT · change in PANSS total scores from baseline to endpoint |
Consumer voice
Consumer input highlighted that long-acting antipsychotics provide treatment stability and improved quality of life, though some concerns were raised about reduced clinical contact and monitoring. The Mental Illness Fellowship of Australia noted potential benefits including reduced stigma, improved compliance, and greater patient empowerment.
long-acting antipsychotics have resulted in benefits for patients including greater treatment stability, fewer visits to the doctor, and shifting the treatment focus from compliance to the improving of quality of life and pursuing goals such as stable employment Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both require adequate treatment with PP 1-month (≥4 months) or 3-month (≥1 cycle) injectable product in adult schizophrenia patients.