PBAC's latest decision on Opicapone: Recommended with restriction (2021). Considered for Adjunctive therapy to levodopa-decarboxylase inhibitor combination in adult patients with Parkinson disease experiencing end-of-dose motor fluctuations.
PBAC outcome
Recommended with restriction
Restricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2021
Submissions
1
2021 → 2021
Eligible population
Adult patients with Parkinson disease on stable levodopa-decarboxylase inhibitor therapy experiencing motor fluctuations due to end-of-dose effects.
Therapy area
Neurology
Line of therapy
Any
Evidence base
RCT
Primary endpoint
Absolute OFF-time
Pivotal trial size
599 patients
Key trials
BIPARK I (BIA-91067-301), BIPARK II
Comparator
entacapone
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated by design.