| Assessment Status | 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 pharmacoeconomic assessment commissioned by 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.
