Venetoclax (Venclyxto®) in combination with obinutuzumab (Gazyvaro®). HTA ID: 20046

Assessment Status Assessment process complete
HTA ID 20046
Drug Venetoclax in combination with obinutuzumab
Brand Venclyxto® / Gazyvaro®
Indication For the treatment of adult patients with previously untreated chronic lymphocytic leukaemia.
Assessment Process
Rapid review commissioned 07/10/2020
Rapid review completed 22/10/2020
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of venetoclax in combination with obinutuzumab compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 27/10/2010
Pre-submission consultation with Applicant 30/11/2020
Full submission received from Applicant 05/02/2021
Preliminary review sent to Applicant 31/05/2021
NCPE assessment re-commenced 30/06/2021
Factual accuracy sent to Applicant 27/07/2021
NCPE assessment re-commenced 04/08/2021
NCPE assessment completed 17/08/2021
NCPE assessment outcome The NCPE recommends that venetoclax in combination with obinutuzumab be considered for reimbursement.*

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 Medicinal Goods) Act 2013.


The HSE has approved reimbursement following confidential price negotiations March 2022.