| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 25020 |
| Drug | Belzutifan |
| Brand | Welireg® |
| Indication | Belzutifan is indicated for the treatment of adult patients with von Hippel-Lindau disease who require therapy for associated, localised renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumours (pNET), and for whom localised procedures are unsuitable. |
| Assessment Process | |
| Rapid review commissioned | 06/03/2025 |
| Rapid review completed | 31/03/2025 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of belzutifan compared with the current standard of care. |
| Full HTA commissioned by the HSE | 30/04/2025 |
| Pre-submission consultation with Applicant | 28/05/2025 |
| Full submission received from Applicant | 13/11/2025 |
| Preliminary review sent to Applicant | 13/02/2026 |
| NCPE assessment re-commenced | 13/03/2026 |
| Factual accuracy sent to Applicant | 22/04/2026 |
| NCPE assessment re-commenced | 29/04/2026 |
| NCPE assessment completed | 25/05/2026 |
| NCPE assessment outcome | The NCPE recommends that belzutifan (Welireg®) not be considered for reimbursement 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.