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 monotherapy treatment option for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy whose tumors express PD-L1 with a combined positive score (CPS) >= 10.

This is written in the approval document as:

As monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy whose tumours express PD-L1 with a combined positive score (CPS) >= 10.

Reimbursement

ODMS

Citation

Pembrolizumab 400mg Monotherapy, 2024, version number 13, NCCP National SACT Regimen, NCCP, viewed 02/08/2026, https://healthservice.hse.ie/documents/6389/558_v12b_Pembrolizumab_400mg_monotherapy.pdf

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
HSE (1)	PD-L1 (CPS) >= 10	Bladder Urothelial Carcinoma	Pembrolizumab

Contributions

Date	Contributor	Description
2024-01-16	Van Allen lab	Adding HSE approvals for reimbursement to database
2021-02-01	Health Service Executive	Indication approved for reimbursement.