The National Institute for Health and Clinical Excellence (NICE) has published its final Technology Appraisal Guidance (TAG) for cenobamate. Cenobamate is recommended by NICE 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. The product 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.
“The publication of the positive guidance by NICE is an important milestone for the management of uncontrolled epilepsy in England and Wales” commented Stuart Mulheron, UK & Ireland General Manager. “The positive opinion enables improved patient access to cenobamate, which Is now available in the UK.”
The published TAG also recommends the availability of the product in Northern Ireland, which was authorised for use through a marketing authorisation granted by the European Commission via the Centralised Procedure in addition to European Union (EU) Member States plus Iceland, Norway and Liechtenstein. The Scottish Medicine Consortium (SMC) is due to issue an opinion on the use of cenobamate by NHS Scotland in early 2022.
Epilepsy is a serious neurological condition that affects 1 in 100 people in the UK and only 52% of people in the UK with epilepsy are seizure free. People with poorly controlled seizures are more likely to experience comorbidities, social stigmatisation and poor quality of life.
“We are very pleased that NICE has recommended cenobamate for use in treating people with focal onset seizures, particularly as a treatment for people whose seizures are currently uncontrolled”, commented Daniel Jennings, Senior Policy & Campaigns Officer at Epilepsy Action. “We know that with the right treatment the number of people whose seizures are controlled could increase significantly. Many people with uncontrolled and hard-to-treat epilepsy have tried a large number of medications without success. We welcome any new treatments that could offer people with epilepsy a better quality of life.”
“Epilepsy can be challenging to manage, especially for people with uncontrolled seizures. In many cases, some treatment regimens cannot prevent or reduce the severity of seizures which can have a significant impact on quality of life and wellbeing. People with epilepsy should be able to access therapeutic options which may improve their condition particularly in terms of seizure freedom at the earliest opportunity,” commented Professor Ley Sander, Professor of Neurology and Head of Department of Clinical & Experimental Epilepsy at UCL Queen Square Institute of Neurology.
The NICE opinion was supported by data from clinical trials involving 1,784 patients. Results from the pivotal trial C017 were published in The Lancet Neurology and demonstrated a reduction in focal (partial)-onset seizures frequency in patients receiving adjunctive cenobamate versus placebo.