National Centre for Pharmacoeconomics

National Centre for

NCPE Ireland

Midostaurin (Rydapt®) is indicated in combination with standard daunorubicin and cytarabine induction and high dose cytarabine consolidation chemotherapy, and for patients in complete response followed by midostaurin single agent maintenance therapy, for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation positive.

NCPE Assessment Process Complete
Rapid review commissioned 13/08/2018
Rapid review completed 10/09/2018
Rapid Review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of midostaurin compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 19/09/2018
Pre-submission consultation with Applicant 15/10/2018
Submission received from Applicant 20/12/2018
Preliminary review sent to Applicant 25/06/2019
NCPE assessment re-commenced 12/08/2019
Factual accuracy sent to Applicant 24/10/2019
NCPE assessment re-commenced 11/11/2019
NCPE assessment completed 04/12/2019
NCPE assessment outcome The NCPE recommends midostaurin (Rydapt®) for AML not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments. *

Technical Summary Midostaurin

Plain English Summary Midostaurin

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