Perampanel
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.
Decisions on record
- Meeting Jul 2017 Recommended Epilepsy
- Meeting Jul 2016 Not recommended Epilepsy
- Meeting Jul 2014 Recommended Fycompa® Eisai Australia Pty Ltd New listing (Major submission) Epilepsy Authority required (Streamlined) listing for the adjunctive treatment of partial epileptic seizures. - perampanel 2 mg once daily is equi-effective to lacosamide 50 mg twice daily; - perampanel 4 mg once daily is equi-effective
Access path
- Jul 2014Recommended · restricted
vs lacosamide
- Jul 2016Not recommended
Inappropriate comparator (placebo rather than active AED comparators), trial population not representative of proposed…
- ↻ resubmittedJul 2017Recommended
Comparator changed: placebo plus standard care (though PBAC considered this inappropriate…
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the listing of perampanel for the treatment of primary generalised tonic-clonic (PGTC) seizures in patients with idiopathic generalised epilepsy (IGE), on the basis of a mixed comparison against placebo in refractory patients who have failed to respond adequately to other anti-epileptic drugs (AED); and against other AEDs (valproate, lamotrigine, levetiracetam and topiramate) for refractory patients in whom perampanel will …PSD · Jul 2017
7.2 The PBAC noted the comments in the sponsor hearing and clinician statement and agreed that there was a clinical need for an additional treatment option for patients with PGTC seizures.PSD · Jul 2017
6.27 The re-submission presented two economic evaluations: A cost-utility analysis of perampanel (plus standard care) vs. placebo (plus standard care). This approach was consistent with the clinical claim of superiority of perampanel compared with placebo; and A cost-minimisation analysis of perampanel (plus standard care) vs. other AEDs (plus standard care).PSD · Jul 2017
6.28 The re-submission presented a modelled economic evaluation for perampanel compared with placebo. The model was the same as the one presented in the previous submission, except that the re-submission used an alternative source for health state utilities, and updated cost and mortality components to the most current estimates. A small change was also made to the transition probabilities from the ‘≤50% response’ transition state.PSD · Jul 2017
6.21 The re-submission described perampanel as superior in terms of comparative effectiveness and inferior in terms of comparative safety to placebo. This is unchanged from the previous submission.PSD · Jul 2017
6.22 The re-submission described perampanel as non-inferior in terms of comparative effectiveness and non-inferior in terms of comparative safety, to either lamotrigine or levetiracetam.PSD · Jul 2017
6.2 The PBAC noted and welcomed the input from several organisations (3) via the Consumer Comments facility on the PBS website. The comments described the need for a variety of treatments to be available to patients with epilepsy.PSD · Jul 2016
6.63 Perampanel is currently PBS listed for partial – onset (or focal) epilepsy and a price- volume based risk-share arrangement exists in conjunction with UCB Biosciences (lacosamide – Vimpat). This is encompassed within a Commonwealth Deed which is intended to expire on 1st April 2020. The sponsor is willing to undertake a separate price-volume, risk-share arrangement for IGE-PGTC.PSD · Jul 2017
Cost-effectiveness
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.
Decision context
PopulationAdults 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.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2017 | Recommended | Placebo (for last-line use) and mixed comparators—lamotrigine or levetiracetam (for substitution use) | — | RCT · Seizure responder rate (50% reduction in PGTC/GTC seizure frequency) |
| Jul 2016 | Not recommended | placebo plus standard care (though PBAC considered this inappropriate and identified valproate, lamotrigine, levetiracet | — | RCT · Seizure frequency (percent change from baseline PGTC seizure frequency per 28 days, and 50% responder rate in maintenance phase) |
| Jul 2014 | Recommended · restricted | lacosamide | — | Meta-analysis · Seizure frequency reduction |
Consumer voice
No consumer comments were received for this item.
The PBAC noted that no consumer comments were received for this item. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricted to refractory patients failing ≥2 prior anti-epileptic drugs; TGA label has no treatment-history requirement.