Regulatory approval

Published by the Health Service Executive. Approved

The Republic of Ireland's Health Service Executive (HSE) has approved niraparib in combination with abiraterone acetate and prednisolone for reimbursement as a treatment option for the treatment of adults with metastatic castration resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated.

This is written in the approval document as:

Niraparib in combination with abiraterone acetate (Akeega) and predniSONE/prednisoLONE for the treatment of adults with metastatic castration resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated.

Reimbursement

CDS

Citation

Niraparib and Abiraterone acetate (Akeega) and prednisoLONE Therapy, 2025, version number 2, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6448/848_v2_Niraparib_abiraterone.pdf

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
HSE (1)	BRCA1 oncogenic variants	Prostate Adenocarcinoma	Abiraterone acetate, Niraparib, Prednisolone
HSE (1)	BRCA2 oncogenic variants	Prostate Adenocarcinoma	Abiraterone acetate, Niraparib, Prednisolone
HSE (1)	BRCA1 pathogenic variants	Prostate Adenocarcinoma	Abiraterone acetate, Niraparib, Prednisolone
HSE (1)	BRCA2 pathogenic variants	Prostate Adenocarcinoma	Abiraterone acetate, Niraparib, Prednisolone

Contributions

Date	Contributor	Description
2026-08-02	Van Allen lab	Initial curation of into moalmanac-db
2024-01-16	Van Allen lab	Adding HSE approvals for reimbursement to database
2023-11-01	Health Service Executive	Indication approved for reimbursement.