| 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 pharmacoeconomic assessment commissioned by 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.