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.