| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 25013 |
| Drug | Ravulizumab |
| Brand | Ultomiris® |
| Indication | Ravulizumab (Ultomiris®) is indicated for the treatment of adult patients with neuromyelitis optica spectrum disorder who are anti-aquaporin 4 antibody positive. |
| Assessment Process | |
| Rapid review commissioned | 17/02/2025 |
| Rapid review completed | 14/03/2025 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of ravulizumab compared with the current standard of care. |
| Full HTA commissioned by the HSE | 31/03/2025 |
| Pre-submission consultation with Applicant | 26/11/2025 |
| Full submission received from Applicant | 10/04/2026 |
| Preliminary review sent to Applicant | 28/07/2026 |
| NCPE assessment re-commenced | 25/08/2026 |
| Factual accuracy sent to Applicant | 02/10/2026 |
| NCPE assessment re-commenced | 09/10/2026 |
| NCPE assessment completed | 28/10/2026 |
| NCPE assessment outcome | The NCPE recommends that ravulizumab not be considered for reimbursement for the treatment of adult patients with NMOSD who are AQP4-IgG+ve *. |
*Next steps: The NCPE Assessment Report and recommendation and Patient Organisation submission, 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.
Please see the HSE Pricing and Reimbursement Tracker for any updates on the reimbursement status of this drug.
