| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 23016 |
| Drug | Ivosidenib |
| Brand | Tibsovo® |
| Indication | For the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R 132 mutation who were previously treated by at least one prior line of systemic therapy |
| Assessment Process | |
| Rapid review commissioned | 08/03/2023 |
| Rapid review completed | 17/04/2023 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of ivosidenib compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 28/06/2023 |
| Pre-submission consultation with Applicant | 05/09/2023 |
| Full submission received from Applicant | 16/02/2024 |
| Preliminary review sent to Applicant | 01/11/2024 |
| NCPE assessment re-commenced | 29/11/2024 |
| Follow-up to preliminary review sent to Applicant | 11/12/2024 |
| NCPE assessment re-commenced | 17/12/2024 |
| Factual accuracy sent to Applicant | 12/02/2025 |
| NCPE assessment re-commenced | 21/02/2025 |
| NCPE assessment completed | 07/03/2025 |
| NCPE assessment outcome | The NCPE recommends that ivosidenib not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
