National Centre for Pharmacoeconomics

National Centre for

NCPE Ireland

Gilteritinib (Xospata®) for Relapsed or Refractory AML. HTA ID: 19043

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*.


Technical Summary

Plain English Summary


* This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.