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Canadian Drug Review Reimbursement Decision

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Generic lacosamide
Company UCB Canada Inc.
Indication epilepsy
Condition Nervous system
Submission Type
Patient Population Lacosamide has a Health Canada indication as adjunctive therapy in the management of partial-onset seizures in adult patients with epilepsy who are not satisfactorily controlled with conventional therapy. Lacosamide is a functionalized amino acid molecule believed to exert its anticonvulsant effect through enhancement of slow inactivation of voltage-gated sodium channels. It is available as oral tablets (50 mg, 100 mg, 150 mg, and 200 mg) and as an intravenous (IV) solution (10 mg/mL), although the manufacturer is not seeking reimbursement for the IV solution at this time. The recommended starting dose is 50 mg twice daily, which should be increased to an initial therapeutic dose of 100 mg twice a day after one week. Depending on patient response and tolerability, the maintenance dose can be further increased by 50 mg twice a day every week, to a maximum recommended daily dose of 400 mg (200 mg twice a day).
Status Complete
Date of Recommendation 2011-04-25
Recommendation Summary List with criteria/condition
Recommendation Details The Canadian Expert Drug Advisory Committee (CEDAC) recommends that lacosamide be listed as adjunctive therapy in patients with refractory partial-onset seizures who meet all of the following criteria: • are under the care of a physician experienced in the treatment of epilepsy, and • are currently receiving two or more antiepileptic drugs, and • in whom all other antiepileptic drugs are ineffective or not appropriate.
Reason for Recommendation 1. In three double-blind randomized controlled trials (RCTs), included in the systematic review considered by CEDAC, lacosamide achieved statistically significant reductions in seizure frequency compared with placebo. 2. Lacosamide is more costly compared with other antiepileptic drugs. Of Note: The Committee noted the numerically higher frequency of serious adverse events, cardiac events, and hospitalizations in lacosamide-treated patients compared with placebo.
Clinical Report:
Pharmacoeconomic Report:
Final Recommendation Report: CDR clinical report  CADTH-CDR Final Recommendation report

†The information referenced on this page is compiled from publicly available documents published by CADTH and is available through the embedded links.

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