Axi-cel is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy.
|NCPE Assessment Process||Complete|
|Rapid review received||10/09/2018|
|Rapid review completed||18/10/2018|
|Rapid Review outcome||A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of axi-cel compared with the current standard of care.|
|Full pharmacoeconomic assessment commissioned by HSE||22/10/2018|
|Pre-submission consultation with Applicant||03/12/2018|
|Submission received from Applicant||20/03/2019|
|Preliminary review sent to Applicant||15/10/2019|
|NCPE assessment re-commenced||13/11/2019|
|Preliminary review # 2 sent to Applicant||13/12/2019|
|NCPE assessment re-commenced||20/12/2019|
|Factual accuracy sent to Applicant||04/02/2020|
|NCPE assessment re-commenced||11/02/2020|
|NCPE assessment complete||21/02/2020|
|NCPE assessment outcome||The NCPE recommend that axicabtagene ciloleucel (Yescarta®) not be considered for reimbursement unless 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 April 2022.