| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 24038 |
| Drug | Enfortumab vedotin in combination with pembrolizumab |
| Brand | Padcev®in combination with Keytruda® |
| Indication | Enfortumab vedotin in combination with pembrolizumab is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer who are eligible for platinum-containing chemotherapy. |
| Assessment Process | |
| Rapid review commissioned | 23/09/2024 |
| Rapid review completed | 22/10/2024 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pembrolizumab compared with the current standard of care. |
| Full HTA commissioned by the HSE | 30/10/2024 |
| Pre-submission consultation with Applicant | 04/12/2024 |
| Full submission received from Applicant | 13/03/2025 |
| Preliminary review sent to Applicant | 08/10/2025 |
| NCPE assessment re-commenced | 05/11/2025 |
| Factual accuracy sent to Applicant | 16/12/2025 |
| NCPE assessment re-commenced | 23/12/2025 |
| NCPE assessment completed | 20/01/2026 |
| NCPE assessment outcome | The NCPE recommends that enfortumab vedotin (Padcev®) in combination with pembrolizumab (Keytruda®) not be considered for reimbursement.* |
*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 2026