| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 23068 |
| Drug | Linzagolix Choline |
| Brand | Yselty® |
| Indication | Linzagolix is indicated for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. |
| Assessment Process | |
| Rapid review commissioned | 09/11/2023 |
| Rapid review completed | 19/12/2023 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of linzagolix compared with the current standard of care. |
| Full HTA commissioned by the HSE | 31/01/2024 |
| Pre-submission consultation with Applicant | 16/04/2024 |
| Full submission received from Applicant | 29/12/2025 |
| Preliminary review sent to Applicant | 06/05/2026 |
| NCPE assessment re-commenced | 05/06/2026 |
| Factual accuracy sent to Applicant | 22/07/2026 |
| NCPE assessment re-commenced | 30/07/2026 |
| NCPE assessment completed | 17/08/2026 |
| NCPE assessment outcome | The NCPE recommends that linzagolix (Yselty) be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments. The HSE may wish to manage the prescribing of linzagolix due to the uncertainty associated with an added benefit over GnRH agonists in patients intended for surgery. Furthermore, linzagolix is also licensed for the treatment of endometriosis which has not been assessed by the NCPE. |
Next steps: The NCPE Assessment Report and recommendation will be considered by the HSE when making their decision on reimbursement, while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.