Regulatory approval

Published by the Health Service Executive. Approved

The Republic of Ireland's Health Service Executive (HSE) has approved nivolumab in combination with ipilimumab as a treatment option for the first-line treatment of adult patient with unresectable or metastatic mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC).

This is written in the approval document as:

Nivolumab in combination with ipilimumab for the first-line treatment of adult patient with unresectable or metastatic mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC).

Reimbursement

ODMS

Citation

Nivolumab 240 mg and Ipilimumab 1mg/kg Therapy, 2025, version number 1a, viewed 02/08/2026, https://healthservice.hse.ie/documents/6653/900_v1a_Nivolumab_240mg_ipilimumab_1mgkg_.pdf

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
HSE (1)	MSI-H	Colorectal Adenocarcinoma	Ipilimumab, Nivolumab
HSE (1)	dMMR	Colorectal Adenocarcinoma	Ipilimumab, Nivolumab

Contributions

Date	Contributor	Description
2025-10-01	Health Service Executive	Indication approved for reimbursement.
2024-01-16	Van Allen lab	Adding HSE approvals for reimbursement to database