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