National Centre for Pharmacoeconomics

National Centre for
Pharmacoeconomics

NCPE Ireland

Darolutamide (Nubeqa®). HTA ID: 20022

Darolutamide is indicated for the treatment of adult men with non-metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.

NCPE Assessment Process Complete
Rapid Review commissioned 27/04/2020
Rapid Review completed 25/05/2020
Rapid Review Outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of darolutamide compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by the HSE 27/05/2020
Pre-submission consultation with Applicant 14/07/2020
Full submission received from Applicant 10/12/2020
Preliminary review sent to Applicant 28/05/2021
NCPE assessment re-commenced 25/06/2021
Factual accuracy check sent to Applicant 20/08/2021
NCPE assessment re-commenced 26/08/2021
NCPE assessment completed 10/09/2021
NCPE assessment outcome The NCPE recommend that darolutamide (Nubeqa®) 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.