Daratumumab (Darzalex®) in combination with bortezomib and dexamethasone

Assessment Status NCPE Assessment Process Complete
Drug Daratumumab
Brand Darzalex® in combination with bortezomib and dexamethasone
Indication For the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
Assessment Process
Rapid review commissioned 09/10/2017
Rapid review completed 27/11/2017
Rapid review outcome A full pharmacoeconomic evaluation is recommended
Full pharmacoeconomic assessment commissioned by HSE 29/11/2017
Pre-submission consultation with Applicant 23/01/2018
Full submission received from Applicant 21/09/2018
Preliminary review sent to Applicant 30/11/2018
NCPE assessment re-commenced 20/12/2018
Factual accuracy sent to Applicant 05/02/2019
NCPE assessment re-commenced 13/02/2019
NCPE assessment completed 15/03/2019
NCPE assessment outcome The NCPE recommends that daratumumab combination (Darzalex®) 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

The HSE has approved reimbursement following confidential price negotiations; October 2020