| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 20036 |
| Drug | Ravulizumab |
| Brand | Ultomiris® |
| Indication | Indicated in the treatment of patients with a body weight of 10 kg or above with atypical haemolytic uremic syndrome (aHUS) who are complement inhibitor treatment-naïve, or have received eculizumab for at least 3 months and have evidence of response to eculizumab. |
| Assessment Process | |
| Rapid review commissioned | 24/07/2020 |
| Rapid review completed | 21/08/2020 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of ravulizumab (Ultomiris®) compared with the current standard of care, on the basis of the proposed price relative to currently available therapies. |
| Full HTA commissioned by the HSE | 27/08/2020 |
| Pre-submission consultation with Applicant | 28/06/2021 |
| Full submission received from Applicant | 05/11/2021 |
| Preliminary review sent to Applicant | 24/03/2022 |
| NCPE assessment re-commenced | 21/04/2022 |
| Follow-up to preliminary review sent to Applicant | 29/04/2022 |
| NCPE assessment re-commenced | 05/05/2022 |
| Additional follow-up to Preliminary Review sent to Applicant | 25/05/2022 |
| NCPE assessment re-commenced | 16/06/2022 |
| Factual accuracy sent to Applicant | 08/07/2022 |
| NCPE assessment re-commenced | 15/07/2022 |
| NCPE assessment completed | 28/07/2022 |
| NCPE assessment outcome | The NCPE recommends that ravulizumab not be considered for reimbursement unless cost effectiveness can be improved relative to comparator treatments*. This recommendation should consider the imminent introduction of eculizumab biosimilars. |
*This recommendation should be considered while also having regard 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 2026.