Gemtuzumab ozogamicin (Mylotarg®)

Assessment Status Assessment process complete
Drug Gemtuzumab ozogamicin
Brand Mylotarg®
Indication For combination therapy with daunorubicin and cytarabine for the treatment of patients age 15 years and above with previously untreated, de novo CD33 positive AML, except acute promyelocytic leukaemia.
Assessment Process
Rapid review commissioned 21/06/2018
Rapid review completed 17/07/2018
Rapid review outcome A full pharmacoeconomic assessment is recommended to assess the clinical effectiveness and cost effectiveness of gemtuzumab ozogamicin compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 31/07/2018
Pre-submission consultation with Applicant 03/09/2018
Full submission received from Applicant 15/11/2018
Preliminary review sent to Applicant 06/03/2019
NCPE assessment re-commenced 01/04/2019
Factual accuracy sent to Applicant 04/06/2019
NCPE assessment re-commenced 17/06/2019
NCPE assessment completed 04/07/2019
NCPE assessment outcome The NCPE recommends that gemtuzumab ozogamicin (Mylotarg®) 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.

The HSE has approved reimbursement following confidential price negotiations; November 2020


Technical Summary