Midostaurin (Rydapt®) for AML

Assessment Status Assessment Process Complete
Drug Midostaurin
Brand Rydapt®
Indication 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.
Assessment Process
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
Full 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

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.

The HSE has approved reimbursement following confidential price negotiations October 2021