National Centre for Pharmacoeconomics

National Centre for

NCPE Ireland

Daratumumab (Darzalex®) in combination with cyclophosphamide, bortezomib and dexamethasone. HTA ID: 21041

Daratumumab (Darzalex®) is indicated in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain amyloidosis.


NCPE Assessment Process Complete
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 the HSE 27/10/2021
Pre-submission consultation scheduled 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
Preliminary review follow-up sent to Applicant 03/11/2022
NCPE assessment re-commenced 09/11/2022
Factual accuracy check 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 (Darzalex®) in combination with bortezomib, cyclophosphamide and dexamethasone not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments*.

Technical Summary

Plain English 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.