Venetoclax (Venclyxto®) in combination with rituximab

Assessment Status Assessment process complete
Drug Venetoclax
Brand Venclyxto®
Indication For the treatment of adult patients with CLL who have received at least one prior therapy.
Assessment Process
Rapid review commissioned 26/09/2018
Rapid review completed 18/10/2018
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of venetoclax compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 23/10/2019
Pre-submission consultation with Applicant 19/11/2018
Full submission received from Applicant 03/01/2019
Preliminary review sent to Applicant 07/05/2019
NCPE assessment re-commenced 05/06/2019
Factual accuracy sent to Applicant 02/10/2019
NCPE assessment re-commenced 09/10/2019
NCPE assessment completed 08/11/2019
NCPE assessment outcome The NCPE recommends that venetoclax in combination with rituximab be considered for reimbursement if 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; July 2020.