Apomorphine Hydrochloride
Recommended NeurologyAuthority RequiredNot applicable line
Treatment of Parkinson's disease in patients with severely disabling motor fluctuations which have not responded to other therapy.
2
Submissions
1 resub
2014–18
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
- Nov 2014Recommended · restricted
- Mar 2018Recommended · restricted
- PBS listing · Authority Required
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
6.1 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 · Mar 2018
6.2 The PBAC was satisfied that the new form would provide a wider dosing range for apomorphine and a more convenient delivery method to PD patients and their carers.PSD · Mar 2018
Economic analysis
5.7 An economic comparison was considered, by the submission, to not be relevant due to the new form of apomorphine being expected to only replace the existing listings and therefore be cost neutral to the Government.PSD · Mar 2018
Clinical claim
5.5 The submission claimed non-inferior comparative effectiveness and non-inferior comparative safety of the apomorphine 30 mg/3 mL compared with the other existing formulations of apomorphine. The PBAC noted that no clinical trials were supplied with this submission to support efficacy and safety of the proposed self-administered form over the current forms which require extraction.PSD · Mar 2018
5.6 In the Pre-PBAC response, the sponsor described an open label study involving 546 participants from 61 centres in the United States, which was to assess the safety and adverse effects of subcutaneous apomorphine injections over a six-year period. The sponsor concluded that no differences in the delivery method were noted.PSD · Mar 2018
Consumer comments
5.2 The PBAC noted that there were no consumer comments for this submission.PSD · Mar 2018
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. Submission assumed cost neutrality based on equivalent cost per mg as existing apomorphine forms.
The PBAC considered that the maximum quantity should be consistent with other forms of apomorphine listed on the PBS (i.e. equivalent to maximum quantity of 60 and a total of 300 units for a total of 9,000 mg apomorphine) at the same cost per mg as the currently listed forms of apomorphine. PBAC · 2018
Cost-effectiveness accepted
Decision context
PopulationPatients with Parkinson's disease who have experienced severely disabling motor fluctuations which have not responded to other therapy.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2018 | Recommended · restricted | apomorphine hydrochloride 20 mg/2 mL ampoule | — | Cost-minimisation · Cost-minimisation |
| Nov 2014 | Recommended · restricted | — | — | Cost-minimisation |
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both TGA label and PBAC indication describe identical populations: Parkinson's disease patients with severely disabling motor fluctuations unresponsive to other therapy.