LacosamideLacosacor
Treatment of primary generalised tonic-clonic seizures in patients with idiopathic generalised epilepsy aged 4 years and older as add-on therapy in patients who have failed satisfactory control with at least two anti-epileptic drugs.
Decisions on record
- Meeting Mar 2021 Recommended Idiopathic generalised epilepsy with primary generalised tonic-clonic seizures
- Meeting Nov 2018 Recommended Partial epileptic seizures
- Meeting Mar 2015 Recommended Intractable partial epileptic seizures
- Meeting Nov 2012 Recommended Epilepsy
- Meeting Nov 2011 Not recommended Epilepsy
- Meeting Mar 2011 Recommended Epilepsy no PSD
- Meeting Nov 2009 Recommended Anti-epileptic drug
Access path
- TGA registered · Lacosacor
TGA label narrower than the PBS population
- Nov 2009Recommended · restricted
vs placebo plus standard care
- Nov 2011Not recommended
inappropriate requested restriction (sodium vs non-sodium AED distinction not clinically meaningful or unambiguous)…
- ↻ resubmittedNov 2012Recommended · restricted
Comparator changed: lamotrigine in combination with any AED → topiramate
- Nov 2012Recommended · restricted
Comparator changed: lamotrigine in combination with any AED → topiramate
- Mar 2015Recommended
Evidence: Meta-analysis → Other
- Nov 2018Recommended · restricted
Evidence: Other → RCT
- Mar 2021Recommended · restricted
Comparator changed: placebo plus standard care → perampanel
- PBS listing · Authority Required
From the public summary
The PBAC recommended the Authority Required (STREAMLINED) listing of lacosamide for the treatment of patients with idiopathic generalised epilepsy (IGE) with primary generalised tonic-clonic seizures (PGTCS). The PBAC’s recommendation for listing was based on, among other matters, its assessment that the cost-effectiveness of lacosamide would be acceptable if it were cost-minimised against perampanel.PSD · Mar 2021
The PBAC considered that there is an unmet clinical need in this patient population, and noted that up to 30% of patients who are treated with currently available AEDs have insufficient seizure control or unacceptable drug tolerability.PSD · Mar 2021
The submission presented a cost-minimisation analysis based on a claim of non- inferiority of lacosamide compared to perampanel.PSD · Mar 2021
The equi-effective doses were estimated as a daily dose relativity of lacosamide to perampanel of 50:1. The submission claimed that equi-effective doses were derived from respective Australian PI’s, data from clinical trials, and PBS usage statistics.PSD · Mar 2021
The submission presented the clinical evidence of lacosamide efficacy and safety (in patients with uncontrolled idiopathic generalised epilepsy with primary generalised tonic-clonic seizures, ≥4 years of age) based on data from Study SP0982.PSD · Mar 2021
The submission described lacosamide as non-inferior to perampanel in terms of both effectiveness and safety. The key issues were: 14PSD · Mar 2021
The PBAC noted and welcomed the input from the National Paediatric Medicines Forum (NPMF) via the Consumer Comments facility on the PBS website. The NPMF described a range of benefits of treatment with lacosamide specifically for paediatric patients, including easy dosing administration in children due to the number of strengths available.PSD · Mar 2021
The submission did not propose any RSA. The RSA in place for the nominated comparator, perampanel, for the treatment of IGE with PGTCS (paragraph 6.63, perampanel PSD, July 2017) was not acknowledged in the submission.PSD · Mar 2021
Cost-effectiveness
Cost-minimisation analysis performed; no ICER calculated as non-inferiority was claimed.
The PBAC considered that this change would not alter current PBS utilisation and expenditure on lacosamide. PBAC · 2015
Decision context
PopulationAdults and children aged 4 years or older with idiopathic generalised epilepsy with primary generalised tonic-clonic seizures who have failed satisfactory control on at least two prior anti-epileptic drugs, requiring add-on therapy with at least one concomitant PBS-subsidised anti-epileptic drug.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2021 | Recommended · restricted | perampanel | — | RCT · 50% responder rate |
| Nov 2018 | Recommended · restricted | placebo plus standard care | — | RCT · PFS |
| Mar 2015 | Recommended | — | — | Other |
| Nov 2012 | Recommended · restricted | topiramate | — | RCT · 50% responder rate, treatment withdrawal (any cause) |
| Nov 2012 | Recommended · restricted | topiramate | — | Meta-analysis · 50% responder rate |
| Nov 2011 | Not recommended | lamotrigine in combination with any AED | — | RCT · 50% responder rate, proportion of patients seizure-free |
| Nov 2009 | Recommended · restricted | placebo plus standard care | — | RCT |
Consumer voice
The National Paediatric Medicines Forum provided input describing benefits of lacosamide for paediatric patients, including easy dosing administration due to available strengths, improved patient compliance, and reduced hospital and GP presentations for uncontrolled seizures.
The NPMF described a range of benefits of treatment with lacosamide specifically for paediatric patients, including easy dosing administration in children due to the number of strengths available. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to add-on therapy after failure of at least two prior anti-epileptic drugs; TGA label permits any add-on use without prior treatment failure requirement.