Venetoclax (Venclyxto®) for Acute Myeloid Leukaemia. HTA ID: 22001

Assessment Status NCPE Assessment Process Complete
HTA ID 22001
Drug Venetoclax
Brand Venclyxto®
Indication In combination with a hypomethylating agent is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.
Assessment Process
Rapid review commissioned 05/01/2022
Rapid review completed 01/02/2022
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of venetoclax in combination with a hypomethylating agent compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 23/02/2022
Pre-submission consultation with Applicant 05/07/2022
Full submission received from Applicant 13/10/2022
Preliminary review sent to Applicant 25/04/2023
NCPE assessment re-commenced 25/05/2023
Factual accuracy sent to Applicant 26/07/2023
NCPE assessment re-commenced 03/08/2023
NCPE assessment completed 26/09/2023
NCPE assessment outcome The NCPE recommends that venetoclax 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.