| 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.