| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 23015 |
| Drug | Ivosidenib |
| Brand | Tibsovo® |
| Indication | To be used in combination with azacitidine, as indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation who are not eligible to receive standard induction chemotherapy. |
| 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 HTA commissioned by the HSE | 28/06/2023 |
| Pre-submission consultation with Applicant | 19/09/2023 |
| Full submission received from Applicant | 21/08/2024 |
| Preliminary review sent to Applicant | 31/07/2025 |
| NCPE assessment re-commenced | 02/09/2025 |
| Factual accuracy sent to Applicant | 26/11/2025 |
| NCPE assessment re-commenced | 03/12/2025 |
| NCPE assessment completed | 16/12/2025 |
| NCPE assessment outcome | The NCPE recommends that ivosidenib not be considered for reimbursement (when given in combination with azacitidine for this indication)*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.