| Assessment Status | Rapid Review Complete |
| HTA ID | 25005 |
| Drug | Elafibranor |
| Brand | Iqirvo® |
| Indication | Elafibranor (Iqirvo®) is indicated for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. |
| Assessment Process | |
| Rapid review commissioned | 27/01/2025 |
| Rapid review completed | 13/03/2025 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of elafibranor compared with the current standard of care, on the basis of the proposed price relative to currently available therapies*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
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.
Further information on the status of this decision may be found here.
