| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 25048 |
| Drug | Givinostat |
| Brand | Duvyzat® |
| Indication | Givinostat (Duvyzat®) is indicated for the treatment of Duchenne Muscular Dystrophy in ambulant patients, aged 6 years and older, and with concomitant corticosteroid treatment. |
| Assessment Process | |
| Rapid review commissioned | 05/08/2025 |
| Rapid review completed | 14/08/2025 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of givinostat compared with the current standard of care. |
| Full HTA commissioned by the HSE | 26/08/2025 |
| Pre-submission consultation with Applicant | 30/09/2025 |
| Full submission received from Applicant | 15/01/2026 |
| Preliminary review sent to Applicant | 22/01/2026 |
| NCPE assessment re-commenced | 19/02/2026 |
| Factual accuracy sent to Applicant | 20/02/2026 |
| NCPE assessment re-commenced | 26/02/2026 |
| NCPE assessment completed | 03/03/2026 |
| NCPE assessment outcome | The NCPE recommends that givinostat not be considered for reimbursement unless cost effectiveness can be improved*. |
Next steps: The NCPE Assessment Report and recommendation, will be considered by the HSE when making their decision on reimbursement, while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Further information on this process may be found here.
Further information on the status of this decision may be found here.
*This recommendation should be considered while also having regards to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.