Tisagenlecleucel (Kymriah®). HTA ID: 22044

Assessment Status NCPE Assessment Process Complete
HTA ID 22044
Drug Tisagenlecleucel
Brand Kymriah®
Indication For the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
Assessment Process
Rapid review commissioned 28/06/2022
Rapid review completed 27/07/2022
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 31/08/2022
Pre-submission consultation with Applicant 06/12/2022
Full submission received from Applicant 14/07/2023
Preliminary review sent to Applicant 06/02/2024
NCPE assessment re-commenced 08/03/2024
Follow-up to preliminary review sent to Applicant 11/04/2024
NCPE assessment re-commenced 18/04/2024
Factual accuracy sent to Applicant 27/05/2024
NCPE assessment re-commenced 05/06/2024
Follow up to factual accuracy check sent to Applicant 16/07/2024
NCPE assessment re-commenced 23/07/2024
NCPE assessment completed 12/08/2024
NCPE assessment outcome The NCPE recommends that tisagenlecleucel not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments*.

Plain English Summary

Technical 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 2025