AripiprazoleAbilify
Recommended Mental healthAuthority Required 💬 consumer voice
Treatment of schizophrenia in adults. The drug is also TGA-registered for maintenance treatment to prevent recurrence of manic or mixed episodes of bipolar I disorder in adult patients as monotherapy, though the PBAC submission focused on schizophrenia.
4
Submissions
2 resub
2014–25
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
- Meeting Jul 2025 Recommended Schizophrenia
- Meeting Dec 2024 Recommended Maintenance treatment of schizophrenia
- Meeting Jul 2024 Deferred Schizophrenia maintenance treatment no PSD
- Meeting Mar 2023 Noted Schizophrenia no PSD
- Meeting Nov 2021 Noted Schizophrenia no PSD
- Meeting Jul 2018 Recommended Schizophrenia
- Meeting Jul 2014 Recommended 300 mg injection: modified release [1 x 300 mg vial] (&) inert substance diluent [2 x 3 mL syringe] 400 mg injection: modified release [1 x 400 mg vial] (&) inert substance diluent [2 x 3 mL syringe] Abilify Maintena® Lundbeck Australia Pty Ltd New listing (Major Submission) Schizophrenia Authority
Access path
- TGA registered · Abilify
TGA label narrower than the PBS population
- Jul 2014Recommended · restricted
vs paliperidone long-acting injection
- Jul 2018Recommended · restricted
Evidence: RCT → Other
- Dec 2024Recommended · restricted
Evidence: Other → RCT
- Jul 2025Recommended · restricted
Comparator changed: aripiprazole once-monthly injection (AOM) → aripiprazole once-monthly…
- PBS listing · Authority Required
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
6.1 The PBAC recommended the listing of AOM 300 mg and 400 mg PFS as an Authority Required (STREAMLINED) benefit for the treatment of schizophrenia under the same listing circumstances as the currently listed AOM vial kit form.PSD · Jul 2025
6.2 The PBAC advised the equi-effective doses as AOM PFS 300 mg = AOM vial kit 300 mg, and AOM PFS 400 mg = AOM vial kit 400 mg.PSD · Jul 2025
Economic analysis
5.7 As a Category 4 submission, the economic analysis was not independently evaluated.PSD · Jul 2025
5.8 The submission presented a cost-minimisation approach of AOM PFS to AOM vial kit, assuming a 1:1 substitution of the vial kit with the PFS and requesting the same price across the respective strengths. The submission estimated the equi-effective doses as 300 mg AOM PFS and 300 mg AOM vial kit, and 400 mg AOM PFS and 400 mg AOM vial kit.PSD · Jul 2025
Clinical claim
5.5 The submission claimed non-inferior comparative effectiveness and safety of AOM PFS to AOM vial kit. No clinical evidence was provided to support this claim. The submission appears to rely on the notion that the PBAC had previously accepted the 400 mg AOM PFS as a suitable alternative to the AOM vial kit of the same strength.PSD · Jul 2025
5.6 The PBAC advised that this clinical claim is appropriate.PSD · Jul 2025
Consumer comments
5.3 The submission stated that in clinical practice, a PFS would be intuitively simpler, easier, and therefore more convenient to administer than a vial kit as both the powder and solvent are supplied within the syringe, eliminating the need to transfer them from vial to syringe. Both AOM vial kit and AOM PFS are to be administered by a healthcare professional, monthly, as a single injection.PSD · Jul 2025
5.4 The submission indicated that there was no intention to delist the current PBS listings of AOM vial kit because the PFS form does not support dose titration where the vial kit does.PSD · Jul 2025
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design.
The PBAC considered that there should be no net financial implications to the PBS/RPBS as AOM PFS is expected to list at the same price as the AOM vial kit with direct 1:1 substitution. PBAC · 2025
Cost-effectiveness accepted ×2
Decision context
PopulationAdults with schizophrenia requiring long-acting injectable aripiprazole treatment.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2025 | Recommended · restricted | aripiprazole once-monthly modified release injection vial kit | — | Cost-minimisation · Cost-minimisation |
| Dec 2024 | Recommended · restricted | aripiprazole once-monthly injection (AOM) | — | RCT · Surrogate |
| Jul 2018 | Recommended · restricted | — | — | Other |
| Jul 2014 | Recommended · restricted | paliperidone long-acting injection | — | RCT · Relapse |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| ASPIRE US | Ph 3 | 709 | Number Of Participants Reporting Severe Treatment-Emergent Adverse Events (TEAE) | completed |
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 narrower than PBS population — PBAC focused on schizophrenia alone, excluding the TGA-registered bipolar I disorder maintenance indication.