ZonisamideZonegran
Recommended NeurologyAuthority RequiredLater-line line
Treatment of partial epileptic seizures, which are not controlled satisfactorily by other anti-epileptic drugs, as adjunctive therapy.
3
Submissions
2007–07
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
- Meeting Mar 2011 Recommended Epilepsy Benign Prostatic Hyperplasia Cystic Fibrosis no PSD
- Meeting Nov 2007 Recommended Epilepsy
Access path
- TGA registered · Zonegran
TGA label narrower than the PBS population
- Nov 2007Recommended · restricted
Evidence: RCT | Meta-analysis → Meta-analysis
- Nov 2007Recommended · restricted
Evidence: RCT | Meta-analysis → Meta-analysis
- Nov 2007Recommended · restricted
Evidence: RCT | Meta-analysis → Meta-analysis
- PBS listing · Authority Required
RecommendedDeferredNot recommended
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated
The PBAC considered that zonisamide appears non inferior and has a no worse side effect profile compared with lamotrigine. PBAC · 2007
Cost-effectiveness accepted
Decision context
PopulationAdult patients with partial seizures (with or without secondary generalisation) not controlled satisfactorily by other anti-epileptic drugs
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2007 | Recommended · restricted | lamotrigine | — | RCT | Meta-analysis · Other |
| Nov 2007 | Recommended · restricted | lamotrigine | — | Meta-analysis · seizure frequency reduction |
| Nov 2007 | Recommended · restricted | lamotrigine | — | Meta-analysis · Responder rate |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to partial seizures not controlled by other anti-epileptic drugs (later-line), whereas TGA label permits adjunctive use in all partial seizure patients.