Ravulizumab (Ultomiris®). HTA ID: 20036

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.

Technical Summary

Plain English Summary

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.