Apomorphine
Treatment of Parkinson disease in patients with severely disabling motor fluctuations refractory to conventional therapy. Maintenance therapy in patients who have been commenced on treatment in a specialist unit in a hospital setting.
Decisions on record
- Meeting Jul 2025 Recommended Parkinson disease
- Meeting Nov 2020 Recommended Parkinson’s disease
- Meeting Mar 2020 Recommended Parkinson disease
- Meeting Jul 2018 Recommended Parkinson disease
- Meeting Mar 2018 Recommended Parkinson disease
- Meeting Nov 2016 Recommended Parkinson disease
- Meeting Jul 2016 Recommended Parkinson disease
Access path
- Jul 2016Recommended · restricted
- Nov 2016Recommended
- Mar 2020Recommended · restricted
Listing: Authority Required → Restricted
- Nov 2020Recommended · restricted
Evidence: Cost-minimisation → RCT
- Jul 2025Recommended · restricted
Evidence: RCT → Cost-minimisation
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended the listing of apomorphine (injection containing apomorphine hydrochloride hemihydrate 100 mg in 20 mL; Movapo POD) as General Schedule Authority Required (STREAMLINED) and Section 100 (Highly Specialised Drugs Program) Authority Required (STREAMLINED) listings, under the same circumstances as apomorphine hydrochloride hemihydrate 100 mg/20 mL injection currently listed on the PBS (Apomine Solution for Infusion), for the treatment …PSD · Jul 2025
6.2 The PBAC considered Apomine Solution for Infusion to be an appropriate comparator, and noted that the TGA established Movapo POD is bioequivalent to Apomine Solution for Infusion. The PBAC recommended listing Movapo POD on a cost-minimisation basis to Apomine Solution for Infusion.PSD · Jul 2025
5.6 As a Committee Secretariat submission, the economic analysis has not been independently evaluated.PSD · Jul 2025
5.7 The submission presented a cost-minimisation approach of Movapo POD compared with Apomine Solution for Infusion. The equi-effective doses were estimated as 1 mg Movapo POD = 1 mg Apomine Solution for Infusion. 5PSD · Jul 2025
5.4 The submission claimed non-inferior comparative effectiveness and non-inferior comparative safety of Movapo POD compared with Apomine Solution for Infusion.PSD · Jul 2025
5.5 The PBAC considered that the claim of non-inferior comparative effectiveness and safety was reasonable.PSD · Jul 2025
5.2 The PBAC noted and welcomed the input from organisations (1) (Parkinson’s Australia Limited) via the Consumer Comments facility on the PBS website. The comment described the challenges of living with Parkinson’s disease, and that it is important to have a range of therapy options available.PSD · Jul 2025
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design
The PBAC recommended listing Movapo POD on a cost-minimisation basis to Apomine Solution for Infusion. PBAC · 2025
Decision context
PopulationPatients with Parkinson disease who have experienced severely disabling motor fluctuations which have not responded to other therapy, and have been commenced on treatment in a specialist unit in a hospital setting.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2025 | Recommended · restricted | Apomine Solution for Infusion (apomorphine hydrochloride hemihydrate 100 mg/20 mL injection) | — | Cost-minimisation · Cost-minimisation |
| Nov 2020 | Recommended · restricted | — | — | RCT · Other |
| Mar 2020 | Recommended · restricted | — | — | Cost-minimisation · Cost-minimisation |
| Nov 2016 | Recommended | — | — | Cost-minimisation · Cost-minimisation |
| Jul 2016 | Recommended · restricted | — | — | Cost-minimisation |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| TOLEDO | Ph 3 | 107 | Mean Change in Daily OFF Time From Baseline (Start of Blinded Treatment) to the End of Dou… | completed |
Consumer voice
Parkinson's Australia Limited described the challenges of living with Parkinson's disease and emphasized the importance of having a range of therapy options available, noting that apomorphine is effective in reducing symptoms and improving quality of life.
The comment described the challenges of living with Parkinson's disease, and that it is important to have a range of therapy options available. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both specify severely disabling motor fluctuations refractory to conventional therapy in specialist-initiated Parkinson's disease patients.