Gilteritinib (Xospata®) as monotherapy is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukaemia (AML) with an FLT3 mutation.
|NCPE Assessment Process||Complete|
|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 gilteritinib compared with the current standard of care.|
|Full pharmacoeconomic assessment 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 check 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.