Tisagenlecleucel (Kymriah®) for pALL

Assessment Status Assessment process complete
Drug Tisagenlecleucel
Brand Kymriah®
Indication For the treatment of paediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse.
Assessment Process
Rapid review commissioned 19/09/2018
Rapid review completed 19/10/2018
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of tisagenlecleucel compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 22/10/2018
Pre-submission consultation with Applicant 06/11/2018
Full submission received from Applicant 30/01/2019
Preliminary review sent to Applicant 11/04/2019
NCPE assessment re-commenced 10/05/2019
Factual accuracy sent to Applicant 23/07/2019
NCPE assessment re-commenced 01/08/2019
NCPE assessment completed 27/08/2019
NCPE assessment outcome The NCPE recommends that tisagenlecleucel (Kymriah®) 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.

Technical Summary

The HSE has approved reimbursement following confidential price negotiations July 2021.