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.

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