Regulatory approval

Published by the Health Service Executive. Approved

The Republic of Ireland's Health Service Executive (HSE) has approved pembrolizumab (200mg and 400mg) for reimbursement as a first-line treatment option for the treatment of adult patients with metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC).

This is written in the approval document as:

First-line treatment of metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) in adults

Reimbursement

ODMS

Citation

Pembrolizumab 200mg Monotherapy, 2026, version number 16, NCCP National SACT Regimen, NCCP, viewed 02/08/2026, https://healthservice.hse.ie/documents/6903/455_V15b__Pembrolizumab_200mg_Monotherapy.pdf

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
HSE (1)	dMMR	Colorectal Adenocarcinoma	Pembrolizumab
HSE (1)	MSI-H	Colorectal Adenocarcinoma	Pembrolizumab

Contributions

Date	Contributor	Description
2024-01-16	Van Allen lab	Adding HSE approvals for reimbursement to database
2023-04-01	Health Service Executive	Indication approved for reimbursement.