Assessment Status | NCPE Assessment Process Complete |
HTA ID | 23048 |
Drug | Fenfluramine (Fintepla®) |
Brand | Fintepla® |
Indication | Fenfluramine (Fintepla®) is indicated for seizures associated with Dravet Syndrome (as an add-on therapy for patients two years of age and older). |
Assessment Process | |
Rapid review commissioned | 31/07/2023 |
Rapid review completed | 07/09/2023 |
Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of fenfluramine compared with the current standard of care. |
Full pharmacoeconomic assessment commissioned by HSE | 29/09/2023 |
Pre-submission consultation with Applicant | 07/11/2023 |
Full submission received from Applicant | 16/05/2024 |
Preliminary review sent to Applicant | 20/05/2024 |
NCPE assessment re-commenced | 17/06/2024 |
Factual accuracy sent to Applicant | 26/06/2024 |
NCPE assessment re-commenced | 02/07/2024 |
NCPE assessment completed | 03/07/2024 |
NCPE assessment outcome | The NCPE recommends that fenfluramine be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments.* |
*This recommendation should be considered while also having regards to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.