| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 22058 |
| Drug | Tucatinib |
| Brand | Tukysa® |
| Indication | In combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer wo have received at least two prior anti-HER2 treatment regimens. |
| Assessment Process | |
| Rapid review commissioned | 23/08/2022 |
| Rapid review completed | 20/09/2022 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of tucatinib compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 28/09/2022 |
| Pre-submission consultation with Applicant | 12/12/2023 |
| Full submission received from Applicant | 14/03/2024 |
| Preliminary review sent to Applicant | 06/12/2024 |
| NCPE assessment re-commenced | 07/03/2025 |
| Follow-up to preliminary review sent to Applicant | 10/04/2025 |
| NCPE assessment re-commenced | 23/05/2025 |
| Additional follow-up to Preliminary Review sent to Applicant | 23/07/2025 |
| NCPE assessment re-commenced | 01/08/2025 |
| Factual accuracy sent to Applicant | 11/08/2025 |
| NCPE assessment re-commenced | 18/08/2025 |
| NCPE assessment completed | 25/09/2025 |
| NCPE assessment outcome | The NCPE recommends that tucatinib not be considered for reimbursement unless 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