Axicabtagene Ciloleucel (Yescarta®)

Assessment Status NCPE Assessment Process Complete
Drug Axicabtagene Ciloleucel
Brand Yescarta®
Indication 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.
Assessment Process
Rapid review commissioned 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
Full submission received from Applicant 20/03/2019
Preliminary review sent to Applicant 15/10/2019
NCPE assessment re-commenced 13/11/2019
Follow-up to preliminary review 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 completed 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.*

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 April 2022.