| Assessment Status | Rapid Review Complete |
| HTA ID | 26003 |
| Drug | Seladelpar |
| Brand | Lyvdelzi® |
| Indication | Seladelpar (Lyvdelzi®) is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA. |
| Assessment Process | |
| Rapid review commissioned | 12/01/2026 |
| Rapid review completed | 06/02/2026 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of seladelpar compared with the current standard of care, on the basis of the proposed price relative to currently available therapies*. |
Next steps: The NCPE Assessment Report and recommendation, 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.