Venetoclax (Venclyxto®) in combination with rituximab is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.
|NCPE Assessment Process||Complete|
|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||23/10/2018|
|Pre-submission consultation with Applicant||19/11/2018|
|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 competed||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.*|
* 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.