For Healthcare Journalists & Media only: NICE expands ONTOZRY®▼(cenobamate) recommendation to allow access and prescription in secondary care.

NICE has now removed the restriction that required cenobamate to be initiated solely in tertiary centres.¹

• Following a NICE Technology Appraisal update, cenobamate can now be initiated in non-tertiary settings, providing more flexibility in patient management.
• Healthcare professionals, with expertise in epilepsy, can access and prescribe cenobamate without needing a referral to a tertiary centre.

Cenobamate, an adjunctive treatment used to manage focal epilepsy in adults with drug-resistant epilepsy that has not been adequately controlled with at least 2 antiseizure medicines², has demonstrated significant clinical benefits in the management of seizures, offering improved seizure control and quality of life for patients.^3,4 However, the initial NICE recommendation that cenobamate could only be initiated in tertiary care centres had presented challenges in ensuring equal access to this treatment. ⁸

The wording in recommendation 1.1 has been updated to address concerns raised by the clinical community that restricting starting treatment in a tertiary care setting has resulted in inequitable access to the treatment. ⁸ This was not in line with the approach taken for other third-generation antiseizure medications (ASMs) at the same stage in the NICE guideline pathway (NG217). ⁵

NICE has now removed the restriction that required cenobamate to be initiated solely in tertiary centres.

The Updated NICE Technology Appraisal on Cenobamate:

1.1. Cenobamate is recommended as an option as an add-on treatment for 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 as a second-line add-on treatment if:

- it is used after at least 1 first-line add-on treatment has not controlled seizures, and other first-line add-on treatments are contraindicated or not tolerated, and

- treatment is started by a healthcare professional with expertise in epilepsy, after which treatment can be continued in primary care.

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. ¹

Dr. Rhys Thomas, Reader in Epilepsy at Newcastle University and Honorary Consultant in Epilepsy at the Royal Victoria Infirmary Newcastle, believes this update will have a positive impact, notably in reducing health inequalities. He stated:

“This is undoubtedly a major boost for the many people with epilepsy who, for no fault of their own, happen to have their care coordinated outside of the major University clinics. This will break down unnecessary barriers to accessing treatments and reduce the inherent postcode lottery”.

About ONTOZRY^® 

ONTOZRY^® contains the active substance cenobamate. It belongs to a group of medicines called ‘anti-epileptics’. These medicines are used to treat epilepsy, a condition where someone has seizures or fits because of abnormal activity in the brain. ²

ONTOZRY^® is used in combination with other anti-epileptic medicines in adult patients with epilepsy who have not been adequately controlled despite treatment with at least 2 anti-epileptic products, to treat a type of epilepsy that has focal-onset seizures, with or without secondary generalisation. Focal-onset seizures are those caused by abnormal brain activity starting in a part of the brain on one side, and secondary generalisation means that the abnormal activity is spreading to both sides of the brain. The medicine can be used only in adults. ²

ONTOZRY^® was first authorised in the UK by the regulatory body in June 2021. ²

About epilepsy

Epilepsy is one of the most widespread neurological diseases in the world, affecting globally approximately 50 million people of all ages.⁶ Epilepsy can have multiple potential causes, including structural, metabolic, genetic and other factors, though approximately half of cases worldwide do not have a known cause.⁶

The complications associated with epilepsy can be severe, with a risk of premature mortality up to three times higher than the general population.⁶ The recurrent seizures associated with this condition also have wide-ranging effects on a person’s broader physical and mental health, education and employment opportunities and other quality of life factors.⁶

Treatments are available to help reduce seizures and improve quality of life, however approximately 30% of people living with epilepsy are still uncontrolled despite the treatment with two ASMs.⁷

About Angelini Pharma

Angelini Pharma is an international pharmaceutical company, part of the privately owned multi-business Angelini Industries. The Company researches, develops and commercializes health solutions with a focus on the areas of Brain Health, including Mental Health and Epilepsy, and Consumer Health. Founded in Italy at the beginning of the 20^th century, Angelini Pharma operates directly in 20 countries, employing more than 3,000 people. Its products are marketed in over 70 countries through strategic alliances with leading international pharmaceutical groups. For more information about Angelini Pharma please visit https://www.angelinipharma.com.

References:

1. NICE – https://www.nice.org.uk/guidance/ta753 (accessed May 2025)
2. Cenobamate Summary of Product Characteristics (accessed May 2025)
3. Krauss GL, et al. Lancet Neurol. 2020 Jan 1;19(1):38-48.
4. Josephson CB, et al. Epilepsia. 2017;58(5):764-71.
5. NICE guideline [NG217]. Epilepsies in children, young people and adults. Published: 27 April 2022. Last updated: 30 January 2025.
6. Epilepsy Key Facts. 7 February 2024. Available from https://www.who.int/news-room/fact-sheets/detail/epilepsy (accessed March 2025).
7. Epilepsy Society. Anti-seizure medication. Available from https://epilepsysociety.org.uk/about-epilepsy/treatment/anti-seizure-medication (accessed March 2025).
8. NICE - Update information | Cenobamate for treating focal onset seizures in epilepsy | Guidance | NICE (accessed May 2025)

MAT-UKI-0226-NP    May 2025