| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 25039 |
| Drug | Trastuzumab Deruxtecan |
| Brand | Enhertu® |
| Indication | Trastuzumab deruxtecan (Enhertu®) is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment. |
| Assessment Process | |
| Rapid review commissioned | 13/06/2025 |
| Rapid review completed | 14/07/2025 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of trastuzumab deruxtecan compared with the current standard of care. |
| Full HTA commissioned by the HSE | 30/07/2025 |
| Pre-submission consultation with Applicant | 10/09/2025 |
| Full submission received from Applicant | 17/04/2026 |
| Preliminary review sent to Applicant | 24/06/2026 |
| NCPE assessment re-commenced | 23/07/2026 |
| Factual accuracy sent to Applicant | 25/08/2026 |
| NCPE assessment re-commenced | 02/09/2026 |
| NCPE assessment completed | 09/09/2026 |
| NCPE assessment outcome | The NCPE recommends that trastuzumab deruxtecan not be considered, for this indication, unless cost effectiveness can be improved relative to existing treatments*. |
*Next steps: The NCPE Assessment Report and recommendation and Patient Organisation submission, 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.
Further information on this process may be found here.
Please see the HSE Pricing and Reimbursement Tracker for any updates on the reimbursement status of this drug.
HSE Pricing and Reimbursement Tracker