PBAC's latest decision on Perampanel: Recommended with restriction (2017). Considered for Idiopathic Generalised Epilepsy with Primary Generalised Tonic-Clonic seizures in patients aged 12 years or older, to be used as an additional therapeutic option in refractory patients or as a last-line add-on treatment.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
3
first 2014
Submissions
3
2014 → 2017
Eligible population
Adults and adolescents aged 12 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 require treatment in combination with at least one PBS subsidised anti-epileptic drug.
Therapy area
Neurology
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
Seizure responder rate (50% reduction in PGTC/GTC seizure frequency)
Placebo (for last-line use) and mixed comparators—lamotrigine or levetiracetam (for substitution use)
Economic model
CUA
ICER note
ICER not stated in the public document. The submission included a cost-utility analysis (vs. placebo) and cost-minimisation analysis (vs. other AEDs), but no numeric ICER is printed in this PSD.
Submission history
Jul 2014: Recommended with restriction · Authority Required
Jul 2016: Not recommended · Authority Required
Jul 2017: Recommended with restriction · Authority Required