Lanadelumab (Takhzyro®)

Assessment Status Assessment process complete
Drug Lanadelumab
Brand Takhzyro®
Indication For routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older.
Assessment Process
Rapid review commissioned 19/03/2019
Rapid review completed 23/05/2019
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of lanadelumab compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 28/05/2019
Pre-submission consultation with Applicant 20/06/2019
Full submission received from Applicant 04/10/2019
Preliminary review sent to Applicant 14/02/2020
NCPE assessment re-commenced 13/03/2020
Factual accuracy sent to Applicant 22/05/2020
NCPE assessment re-commenced 03/06/2020
NCPE assessment completed 26/06/2020
NCPE assessment outcome The NCPE recommends that lanadelumab 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

Plain English Summary

The HSE has approved reimbursement following confidential price negotiations September 2021