Daratumumab (Darzalex®). HTA ID: 21041

Assessment Status NCPE Assessment Process Complete
HTA ID 21041
Drug Daratumumab
Brand Darzalex® in combination with cyclophosphamide, bortezomib and dexamethasone
Indication For the treatment of adult patients with newly diagnosed systemic light chain amyloidosis.
Assessment Process
Rapid review commissioned 03/09/2021
Rapid review completed 13/10/2021
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of daratumumab compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 27/10/2021
Pre-submission consultation with Applicant 18/01/2022
Full submission received from Applicant 19/04/2022
Preliminary review sent to Applicant 26/09/2022
NCPE assessment re-commenced 24/10/2022
Follow-up to preliminary review sent to Applicant 03/11/2022
NCPE assessment re-commenced 09/11/2022
Factual accuracy sent to Applicant 02/12/2022
NCPE assessment re-commenced 09/12/2022
NCPE assessment completed 19/12/2022
NCPE assessment outcome The NCPE recommends that daratumumab in combination with bortezomib, cyclophosphamide and dexamethasone 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