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