Assessment Status | NCPE Assessment Process Complete |
HTA ID | 23051 |
Drug | Fenfluramine |
Brand | Fintepla® |
Indication | Fenfluramine (Fintepla®) is indicated for patients (two years of age and older) with Lennox-Gastaut Syndrome as an add-on therapy to other anti-epileptic medicines. |
Assessment Process | |
Rapid review commissioned | 09/08/2023 |
Rapid review completed | 14/09/2023 |
Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of fenfluramine for this indication 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 | 01/08/2024 |
Preliminary review sent to Applicant | 07/08/2024 |
NCPE assessment re-commenced | 02/09/2024 |
Factual accuracy sent to Applicant | 04/09/2024 |
NCPE assessment re-commenced | 11/09/2024 |
NCPE assessment completed | 16/09/2024 |
NCPE assessment outcome | The NCPE recommends that fenfluramine be considered for reimbursement if cost-effectiveness can be improved.* |
*This recommendation should be considered while also having regards to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
The HSE has approved reimbursement following confidential price negotiations. March 2025