| Assessment Status | 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.
