1.1 Cenobamate is recommended as an option for treating focal onset seizures with or without secondary generalised seizures in adults with drug-resistant epilepsy that has not been adequately controlled with at least 2 antiseizure medicines. It is recommended only if:
it is used as an add-on treatment, after at least 1 other add-on treatment has not controlled seizures, and
treatment is started in a tertiary epilepsy service.
1.2 This recommendation is not intended to affect treatment with cenobamate that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.
Why the committee made these recommendations
Treatment for focal onset seizures includes many antiseizure medicines used on their own and in combination. Treatment options for focal onset seizures after at least 2 antiseizure medicines are not very effective.
Short-term clinical evidence shows that cenobamate reduces the number of seizures. It also increases how many people stop having any seizures. It is uncertain how this compares with other antiseizure medicines because cenobamate has not been directly compared with them. The results of an indirect comparison are uncertain because the clinical trials included are short and have different designs. Because it is unclear how the benefit of cenobamate compares with its risks, it should only be started in a tertiary epilepsy service.
Taking into account uncertainties with the clinical evidence, the most likely cost-effectiveness estimates for cenobamate are within what NICE normally considers an acceptable use of NHS resources. So, it is recommended for drug-resistant epilepsy as an add-on treatment in a tertiary epilepsy service, after at least 1 add-on treatment has not controlled symptoms.