LevetiracetamAPO-Levetiracetam Oral
Recommended NeurologyAuthority Required
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.
1
Submissions
1 resub
2008–08
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
- Meeting Mar 2010 Recommended Epilepsy no PSD
- Meeting Nov 2008 Recommended Anti-epileptic
- Meeting Nov 2007 Recommended Epilepsy no PSD
- Meeting Jun 2001 Recommended Antiepileptic no PSD
Access path
- TGA registered · APO-Levetiracetam Oral
TGA label equal than the PBS population
- Nov 2008Recommended · restricted
vs lamotrigine
- PBS listing · Authority Required
RecommendedDeferredNot recommended
Cost-effectiveness
Cost-minimisation analysis conducted; no ICER calculated by design.
Cost-effectiveness accepted
Decision context
PopulationAdults and children aged 4 years and older with primary generalised tonic clonic seizures or generalised myoclonic seizures (juvenile myoclonic epilepsy) as add-on therapy.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2008 | Recommended · restricted | lamotrigine | — | RCT · Seizure reduction (50% responder rate) |
Similar precedents
Regulatory · TGA
Label equal than PBS population — PBAC recommendation covers the same seizure types (PGTC and myoclonic) and age group (4+ years) as the TGA add-on therapy indications for IGE.