Apalutamide (Erleada®) for nmCRPC

Assessment Status NCPE Assessment Process Complete
Drug Apalutamide
Brand Erleada®
Indication For the treatment of non-metastatic castration resistant prostate cancer (nmCRPC) at high risk of developing metastatic disease.
Assessment Process
Rapid review commissioned 30/01/2019
Rapid review completed 27/02/2019
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of apalutamide in combination with ADT compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 06/03/2019
Pre-submission consultation with Applicant 28/05/2019
Full submission received from Applicant 12/12/2019
Preliminary review sent to Applicant 10/04/2020
NCPE assessment re-commenced 04/06/2020
Factual accuracy sent to Applicant 01/07/2020
NCPE assessment re-commenced 09/07/2020
NCPE assessment completed 04/08/2020
NCPE assessment outcome The NCPE recommend that apalutamide (Erleada®) 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 August 2021