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.

The HSE has approved reimbursement following confidential price negotiations. June 2024