Liposomal daunorubicin and cytarabine (Vyxeos Liposomal®)

Assessment Status Assessment process complete
Drug Liposomal daunorubicin and cytarabine
Brand Vyxeos Liposomal®
Indication For the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes.
Assessment Process
Rapid review commissioned 28/09/2018
Rapid review completed 08/11/2018
Rapid review outcome Full Pharmacoeconomic Assessment Recommended.
Full pharmacoeconomic assessment commissioned by HSE 14/11/2018
Pre-submission consultation with Applicant 15/01/2019
Full submission received from Applicant 31/05/2019
Preliminary review sent to Applicant 02/10/2019
NCPE assessment re-commenced 06/11/2019
Factual accuracy sent to Applicant 28/02/2020
NCPE assessment re-commenced 09/03/2020
NCPE assessment completed 16/04/2020
NCPE assessment outcome The NCPE recommends that Liposomal daunorubicin and cytarabine (Vyxeos Liposomal®) 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.

Technical Summary

Plain English Summary

The HSE has approved reimbursement following confidential price negotiations February 2021.