Ravulizumab (Ultomiris®) HTA ID: 20036
Ravulizumab is 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.
| NCPE Assessment Process | Complete |
| 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 the HSE | 27/08/2020 |
| Pre-submission consultation with Applicant | 28/06/2021 |
| Full HTA 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 |
| Follow up II to Preliminary review sent to Applicant | 25/05/2022 |
| NCPE assessment re-commenced | 16/06/2022 |
| Factual accuracy check 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.