| Assessment Status | 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 pharmacoeconomic assessment commissioned by 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.