Regulatory approval

Published by the Health Service Executive. Approved

The Republic of Ireland's Health Service Executive (HSE) has approved gemcitabine (1000mg/m^2) in combination with carboplatin (AUC 5) (21 day) and nivolumab for reimbursement as a treatment option for the neoadjuvant treatment of resectable NSCLC at high risk of recurrence in adult patients whose tumours have PD-L1 expression >= 1% (3 cycles only). The regimen further states that this combination is available in NCIS (00849.2).

This is written in the approval document as:

In combination with nivolumab for the neoadjuvant treatment of resectable NSCLC at high risk of recurrence in adult patients whose tumours have PD-L1 expression >= 1% (3 cycles only). This combination is available in NCIS (00849.2)

Reimbursement

Incomplete Reimbursement

Nivolumab - ODMS 2024-05-01; Chemotherapy - N/A

Citation

Gemcitabine (1000mg/m2) and CARBOplatin (AUC 5) Therapy - 21 day, 2025, version number 7, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6713/310_v7_GemCARBOAUC_5.pdf

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
HSE (1)	PD-L1 >= 1%	Non-Small Cell Lung Cancer	Carboplatin, Gemcitabine, Nivolumab

Contributions

Date	Contributor	Description
2024-05-01	Health Service Executive	Indication approved for reimbursement.
2024-01-16	Van Allen lab	Adding HSE approvals for reimbursement to database