| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 21049 |
| Drug | Nivolumab |
| Brand | Opdivo® |
| Indication | Nivolumab is indicated in combination with fluoropyrimidine and platinum-based combination chemotherapy for the first line treatment of adult patients with HER2 negative advanced or metastatic gastric, gastro oesophageal junction or oesophageal adenocarcinoma whose tumours express PD-L1 with a combined positive score (CPS) ≥5. |
| Assessment Process | |
| Rapid review commissioned | 01/11/2021 |
| Rapid review completed | 29/11/2021 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of nivolumab compared with the current standard of care. |
| Full HTA commissioned by the HSE | 07/12/2021 |
| Pre-submission consultation with Applicant | 01/02/2022 |
| Full submission received from Applicant | 10/10/2022 |
| Preliminary review sent to Applicant | 27/03/2023 |
| NCPE assessment re-commenced | 03/05/2023 |
| Factual accuracy sent to Applicant | 16/06/2023 |
| NCPE assessment re-commenced | 30/06/2023 |
| NCPE assessment completed | 11/07/2023 |
| NCPE assessment outcome | The NCPE recommends that nivolumab (Opdivo®) in combination with chemotherapy not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
The HSE has approved reimbursement following confidential price negotiations February 2026.