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 for reimbursement as a treatment option for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer (MSI-H mCRC) after prior fluoropyrimidine-based combination chemotherapy.

This is written in the approval document as:

Nivolumab in combination with ipilimumab for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer (MSI-H mCRC) after prior fluoropyrimidine-based combination chemotherapy.

Reimbursement

ODMS

Citation

Nivolumab 3mg/kg with Ipilimumab 1mg/kg Therapy, 2021, version number 5, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6385/551_Nivolumab_3mgkg_Ipilimumab_1mgk.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
2024-01-16	Van Allen lab	Adding HSE approvals for reimbursement to database
2023-06-01	Health Service Executive	Indication approved for reimbursement.