Cenobamate (Ontozry®). HTA ID: 21025

Assessment Status NCPE Assessment Process Complete
HTA ID 21025
Drug Cenobamate
Brand Ontozry®
Indication Adjunctive treatment of focal onset seizures with or without secondary generalisation in adult patients with epilepsy who have not been adequately controlled despite a history of treatment with at least two anti-epileptic medicinal products.
Assessment Process
Rapid review commissioned 09/06/2021
Rapid review completed 05/07/2021
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of cenobamate compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 22/07/2021
Pre-submission consultation with Applicant 06/09/2021
Full submission received from Applicant 13/12/2021
Preliminary review sent to Applicant 27/04/2022
NCPE assessment re-commenced 27/05/2022
Factual accuracy sent to Applicant 04/08/2022
NCPE assessment re-commenced 11/08/2022
NCPE assessment completed 06/10/2022
NCPE assessment outcome The NCPE recommends that cenobamate (Ontozry®) be considered for reimbursement as a second- or subsequent-line adjunctive treatment of focal onset seizures in adult patients with epilepsy who have failed treatment with two or more previous anti-seizure medicines, including at least one adjunctive therapy*.

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

Technical Summary

Plain English Summary

The HSE has approved reimbursement following confidential price negotiations; May 2023