Daratumumab (Darzalex®). HTA ID: 20025

Assessment Status NCPE Assessment Process Complete
HTA ID 20025
Drug Daratumumab
Brand Darzalex®
Indication In combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.
Assessment Process
Rapid review commissioned 02/06/2020
Rapid review completed 17/07/2020
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 04/08/2020
Full submission received from Applicant 12/03/2021
Preliminary review sent to Applicant 19/07/2021
NCPE assessment re-commenced 19/08/2021
Factual accuracy sent to Applicant 04/10/2021
NCPE assessment re-commenced 11/10/2021
NCPE assessment completed 16/11/2021
NCPE assessment outcome The NCPE recommend that daratumumab (Darzalex®) be considered for reimbursement if 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.

The HSE has approved reimbursement following confidential price negotiations June 2022.