| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 22007 |
| Drug | Sacituzumab govitecan |
| Brand | Trodelvy® |
| Indication | Is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, including at least one of them for advanced disease. |
| Assessment Process | |
| Rapid review commissioned | 07/02/2022 |
| Rapid review completed | 08/03/2022 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of sacituzumab govitecan compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 01/04/2022 |
| Pre-submission consultation with Applicant | 25/04/2022 |
| Full submission received from Applicant | 10/08/2022 |
| Preliminary review sent to Applicant | 22/12/2022 |
| NCPE assessment re-commenced | 01/02/2023 |
| Follow-up to preliminary review sent to Applicant | 13/02/2023 |
| NCPE assessment re-commenced | 16/02/2023 |
| Factual accuracy sent to Applicant | 09/03/2023 |
| NCPE assessment re-commenced | 20/03/2023 |
| NCPE assessment completed | 24/03/2023 |
| NCPE assessment outcome | The NCPE recommends that sacituzumab govitecan be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
The HSE has approved reimbursement following confidential price negotiations. September 2024
