Romosozumab (Evenity®). HTA ID: 21016

Assessment Status NCPE Assessment Process Complete
HTA ID 21016
Drug Romosozumab
Brand Evenity®
Indication For the treatment of severe osteoporosis in postmenopausal women at high risk of fracture.
Assessment Process
Rapid review commissioned 21/04/2021
Rapid review completed 27/05/2021
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of romosozumab compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 28/06/2021
Pre-submission consultation with Applicant 10/08/2021
Full submission received from Applicant 01/07/2022
Preliminary review sent to Applicant 28/10/2022
Follow-up to preliminary review sent to Applicant 01/12/2022
NCPE assessment re-commenced 19/12/2022
Factual accuracy sent to Applicant 08/02/2023
NCPE assessment re-commenced 14/02/2023
NCPE assessment completed 07/03/2023
NCPE assessment outcome The NCPE recommends that romosozumab (Evenity®), for the treatment of women who are postmenopausal with severe osteoporosis who have experienced a MOF (hip, vertebrae, distal radius, proximal humerus) within the previous 24 months and who are at imminent risk of another fragility fracture, be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments*.

Technical Summary

Plain English Summary

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