PBAC's latest decision on Levodopa with carbidopa and entacapone: Noted (2024). Considered for Advanced idiopathic Parkinson's disease with severe motor fluctuations despite optimised alternative pharmacological treatment.
PBAC outcome
Noted
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
2
first 2024
Submissions
2
2024 → 2024
Eligible population
Adults with advanced idiopathic Parkinson's disease and severe motor fluctuations not adequately controlled by at least one of: oral therapy or intestinal gel formulation containing levodopa
Therapy area
Neurology
Line of therapy
Later-line
Evidence base
Single-arm
Primary endpoint
Surrogate
Pivotal trial size
11 patients
Key trials
LSM-003, ELEGANCE, GLORIA, DUOGLOBE
Comparator
levodopa, carbidopa monohydrate intestinal gel (LCIG)
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis proposed; no numeric ICER calculated or stated
Risk sharing
Risk-sharing arrangement in place — LECIG proposed to be included in the same risk-sharing arrangement as LCIG to mitigate financial risk to PBS of utilisation beyond base-case estimates
Submission history
Mar 2024: Recommended with restriction · Authority Required