PBAC's latest decision on Lacosamide: Recommended with restriction (2021). Considered for Treatment of primary generalised tonic-clonic seizures in patients with idiopathic generalised epilepsy aged 4 years and older, as add-on therapy in patients who have failed to be controlled satisfactorily by at least two anti-epileptic drugs.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
5
first 2011
Submissions
5
2011 → 2021
Eligible population
Adults and children aged 4 years or older with idiopathic generalised epilepsy with primary generalised tonic-clonic seizures who have failed to be controlled satisfactorily by at least two anti-epileptic drugs and are receiving add-on therapy with at least one PBS-subsidised anti-epileptic drug.
Therapy area
Neurology
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
ORR
Pivotal trial size
242 patients
Key trials
SP0982, Study 332
Comparator
perampanel
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated by design.
Submission history
Nov 2011: Not recommended
Nov 2012: Recommended with restriction
Mar 2015: Recommended · Restricted
Nov 2018: Recommended with restriction · Authority Required
Mar 2021: Recommended with restriction · Authority Required