| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 24033 |
| Drug | Omaveloxolone |
| Brand | Skyclarys® |
| Indication | For the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older |
| Assessment Process | |
| Rapid review commissioned | 02/08/2024 |
| Rapid review completed | 29/08/2024 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of omaveloxolone compared with the current standard of care. |
| Full HTA commissioned by the HSE | 25/09/2024 |
| Pre-submission consultation with Applicant | 04/02/2025 |
| Full submission received from Applicant | 02/07/2025 |
| Preliminary review sent to Applicant | 17/09/2025 |
| NCPE assessment re-commenced | 29/10/2025 |
| Factual accuracy sent to Applicant | 27/11/2025 |
| NCPE assessment re-commenced | 04/12/2025 |
| NCPE assessment completed | 16/12/2025 |
| NCPE assessment outcome | The NCPE recommends that omaveloxolone not be considered for reimbursement*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.