The National Institute for Health and Clinical Excellence (NICE) has issued a Final Appraisal Determination (FAD) for Cenobamate▼ (ONTOZRY®).
The published FAD recommends cenobamate 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 two antiseizure medicines. It is recommended only if it is used as an add-on treatment, after at least one other add-on treatment has not controlled seizures, and treatment is started in a tertiary epilepsy service.
Stuart Mulheron, General Manager UK & Ireland, Angelini Pharma said: “Angelini Pharma is committed to improving seizure control for people living with epilepsy. Today’s positive recommendation for cenobamate by NICE is testament to the strength of key trial data and offers the prospect of better management for people affected by uncontrolled seizures in the UK. The FAD is a significant milestone for cenobamate and takes us closer towards reimbursement in England and Wales, we look forward to the full ‘technology appraisal guidance’ (TAG) which is due to be published in early December 2021.”
Dr Rhys Thomas, Honorary Consultant in Epilepsy, Royal Victoria Infirmary, Newcastle commented: “Today’s announcement by NICE is a potentially landmark decision for people with uncontrolled focal epilepsy. The decision recognises the importance of aiming for seizure freedom and the potential benefits to the health and wellbeing of people who live with frequent seizures.”
 National Institute for Health and Care Excellence. Final appraisal document. Cenobamate for treating focal onset seizures in epilepsy. Available at: https://www.nice.org.uk/guidance/gid-ta10661/documents/final-appraisal-determination-document. Accessed: November 2021