| 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.
The HSE has approved reimbursement following confidential price negotiations. November 2024
