SafinamideXadago
Recommended NeurologyRestrictedLater-line line 💬 consumer voice
Add-on therapy to levodopa in patients with Parkinson's disease experiencing motor fluctuations.
1
Submissions
2018–18
On the record
—
ICER range
Cost-min
Cost basis
Decision on record
- Meeting Nov 2018 Recommended Parkinson disease
Access path
- TGA registered · Xadago
TGA label narrower than the PBS population
- Nov 2018Recommended · restricted
vs rasagiline
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
7.1 The PBAC recommended the listing of safinamide on the General Schedule as a Restricted Benefit listing for treatment of Parkinson’s disease (PD), as add-on therapy to levodopa, on the basis of cost-minimisation compared to rasagiline. The equi- effective doses are safinamide 100 mg/day and rasagiline 1 mg/day.PSD · Nov 2018
7.2 The PBAC noted that the terms mid-to-late stage disease and requirement for a stable dose of levodopa were excluded from the TGA indication and the final indication is for the treatment of adult patients with fluctuating idiopathic Parkinson’s disease as add- on therapy to a regimen that includes levodopa.PSD · Nov 2018
Economic analysis
6.38 The equi-effective doses were estimated as safinamide 100 mg daily and 1mg rasagiline daily.PSD · Nov 2018
6.39 The submission justified these equi-effective doses on the following basis: Rasagiline 1 mg is the only dose of this medicine listed on the PBS. All rasagiline clinical trials presented in the submission included a rasagiline 1 mg/day treatment arm; The equi-effective dose for safinamide was based on the therapeutic conclusion that safinamide 100 mg/day is non-inferior to rasagiline 1 mg/day in terms of both efficacy and safety.PSD · Nov 2018
Clinical claim
6.33 The submission described safinamide as non-inferior to rasagiline in terms of efficacy and safety.PSD · Nov 2018
6.34 The submission’s clinical claim should be viewed within the context of concerning heterogeneity among the safinamide and rasagiline studies that may distort indirect 16PSD · Nov 2018
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design.
Decision context
PopulationAdult patients with fluctuating idiopathic Parkinson's disease as add-on therapy to levodopa, with safinamide 50 mg or 100 mg once daily compared to rasagiline 1 mg once daily.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2018 | Recommended · restricted | rasagiline | — | RCT · ON time without troublesome dyskinesia |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| SETTLE | Ph 3 | 549 | Evaluate the change from baseline to W24 in daily "on" time ("on" time without dyskinesia … | 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 restricts to later-line therapy and specifies comparison to rasagiline, narrowing the TGA's broader add-on indication.