PBAC's latest decision on Levetiracetam: Recommended with restriction (2008). Considered for Extension of listing to include treatment of primary generalised tonic clonic seizures (PGTCS) and generalised myoclonic seizures as add-on therapy in patients with idiopathic generalised epilepsy.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2008
Submissions
1
2008 → 2008
Eligible population
Adults and children aged 4 years and older with primary generalised tonic clonic seizures or generalised myoclonic seizures (juvenile myoclonic epilepsy) as add-on therapy.
Therapy area
Neurology
Line of therapy
Any
Evidence base
RCT
Primary endpoint
Seizure reduction (50% responder rate)
Pivotal trial size
162 patients
Key trials
N01057, Biton 1999, Biton 2005, N166
Comparator
lamotrigine
Economic model
Cost-minimisation
Budget impact
$10M
Eligible patients/year
10,000
ICER note
Cost-minimisation analysis conducted; no ICER calculated by design.