Regulatory approval

Published by the Health Service Executive. Approved

The Republic of Ireland's Health Service Executive (HSE) has approved nivolumab (480mg) in combination with flouropyrimidine and platinum-based chemotherapy for reimbursement as a treatment option for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (OSCC) with tumor cell programmed death ligang 1 (PD-L1) expression >= 1%.

This is written in the approval document as:

Nivolumab in combination with fluoropyrimidine and platinum-based combination chemotherapy for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (OSCC) with tumour cell programmed death ligand 1 (PD-L1) expression >= 1%.

Reimbursement

Incomplete Reimbursement

Nivolumab - ODMS; Cisplatin, 5-Fluorouracil - N/A

Citation

Nivolumab 480mg, CISplatin 80mg/m2 and 5-Fluorouracil Infusional Therapy, 2023, version number 1, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6433/832_Nivolumab_28-day_Cisplatin_5FU_.pdf

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
HSE (1)	PD-L1 >= 1%	Esophageal Squamous Cell Carcinoma	Cisplatin, Fluorouracil, Nivolumab

Contributions

Date	Contributor	Description
2024-01-16	Van Allen lab	Adding HSE approvals for reimbursement to database
2023-07-01	Health Service Executive	Indication approved for reimbursement.