PBAC's latest decision on Foslevodopa with foscarbidopa: Recommended with restriction (2024). Considered for Treatment of advanced Parkinson's disease with severe disabling motor fluctuations not adequately controlled by oral therapy.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
2
first 2024
Submissions
2
2024 → 2024
Eligible population
Patients with advanced Parkinson's disease with severe disabling motor fluctuations not adequately controlled by oral therapy.
Therapy area
Neurology
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
Other
Pivotal trial size
141 patients
Key trials
M15-736, Olanow 2015
Comparator
levodopa/carbidopa intestinal gel (LCIG)
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis (CMA) conducted; no ICER calculated. The submission was based on a claim of non-inferior comparative effectiveness and cost-minimisation (not cost-effectiveness).
Risk sharing
Risk-sharing arrangement in place — Risk Sharing Arrangement (RSA) structure proposed where FosLD/FosCD would join the existing RSA for LCIG (and potentially LECIG), with increased caps to account for additional use and a proposed rebate level.
Submission history
May 2024: Recommended with restriction · Authority Required
Nov 2024: Recommended with restriction · Authority Required