| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 19043 |
| Drug | Gilteritinib |
| Brand | Xospata® |
| Indication | For the treatment of adult patients with relapsed or refractory acute myeloid leukaemia (AML) with an FLT3 mutation. |
| Assessment Process | |
| Rapid review commissioned | 14/10/2019 |
| Rapid review completed | 29/11/2019 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of gliterinib compared with the current standard of care.* |
| Full HTA commissioned by the HSE | 02/12/2019 |
| Pre-submission consultation with Applicant | 03/02/2020 |
| Full submission received from Applicant | 12/06/2020 |
| Preliminary review sent to Applicant | 23/10/2020 |
| NCPE assessment re-commenced | 23/11/2020 |
| Factual accuracy sent to Applicant | 04/02/2021 |
| NCPE assessment re-commenced | 11/02/2021 |
| NCPE assessment completed | 03/03/2021 |
| NCPE assessment outcome | The NCPE recommends that gilteritinib (Xospata®) should 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.
The HSE has approved reimbursement following confidential price negotiations. October 2025