Apomorphine Hydrochloride HemihydrateApomine
Recommended NeurologyAuthority Required
Treatment of Parkinson's disease in patients with severely disabling motor fluctuations that have not responded to other therapy.
1
Submissions
1 resub
2018–18
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
- Meeting Nov 2014 Recommended 10 mg /1 mL injection: 5 x 1 mL ampoules, Apomine® Hospira Pty Ltd New listing (Minor submission) Parkinson disease Section 100 Authority Required listing of a lower strength for the management of advanced Parkinson disease.
- Meeting Mar 2009 Recommended Parkinson disease no PSD
- Meeting Mar 2007 Recommended Parkinson’s disease no PSD
- Meeting Mar 2007 Recommended Parkinson’s disease no PSD
Access path
- TGA registered · Apomine
TGA label equal than the PBS population
- Jul 2018Recommended
- PBS listing · Authority Required
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
5.1 The PBAC recommended the Authority Required listing of a new form of apomorphine (30 mg in 3 mL) delivered in a disposable multiple dose pen injector system for the treatment of Parkinson’s disease (PD), on the basis that it should be available under Section 100, Highly Specialised Drugs (HSD) Program.PSD · Jul 2018
5.2 The PBAC accepted the sponsor’s claim that this form of apomorphine would substitute existing use of the currently PBS-listed forms of apomorphine, without increasing the overall utilisation. As such, and given that the sponsor requested a price equivalent to the lowest price currently listed for apomorphine, the PBAC agreed that this listing was likely to have negligible net financial implications for the PBS.PSD · Jul 2018
Clinical claim
4.4 As an additional presentation, the submission assumed that the new form was non-inferior to the currently listed forms. The submission claimed that the reusable 2PSD · Jul 2018
Cost-effectiveness
Minor submission with no economic evaluation; cost-minimisation (no net financial impact expected)
Cost-effectiveness accepted
Decision context
PopulationAdults with Parkinson's disease who have experienced severely disabling motor fluctuations that have not responded to other therapy.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2018 | Recommended | — | — | Cost-minimisation |
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both TGA label and PBAC recommendation specify the same population: Parkinson's disease patients with severely disabling motor fluctuations unresponsive to other therapy.