PBAC's latest decision on Safinamide: Recommended with restriction (2018). Considered for Add-on therapy to levodopa in patients with Parkinson's disease experiencing motor fluctuations.
PBAC outcome
Recommended with restriction
Restricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2018
Submissions
1
2018 → 2018
Eligible population
Adult 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.
Therapy area
Neurology
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
ON time without troublesome dyskinesia
Key trials
Study 016, SETTLE, PRESTO, LARGO, Zhang, Hauser, Hattori, CHORAL, 13484A
Comparator
rasagiline
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated by design.