| Assessment Status | Assessment Process Complete |
| HTA ID | - |
| Drug | Nivolumab |
| Brand | Opdivo® |
| Indication | Nivolumab in combination with ipilimumab for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (RCC) for RCC. |
| Assessment Process | |
| Rapid review commissioned | 28/11/2018 |
| Rapid review completed | 11/12/2018 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Recommended |
| Full pharmacoeconomic assessment commissioned by HSE | 19/12/2018 |
| Pre-submission consultation with Applicant | 28/01/2019 |
| Full submission received from Applicant | 01/04/2019 |
| Preliminary review sent to Applicant | 23/09/2019 |
| NCPE assessment re-commenced | 21/10/2019 |
| Factual accuracy sent to Applicant | 28/11/2019 |
| NCPE assessment re-commenced | 06/12/2019 |
| NCPE assessment completed | 07/01/2020 |
| NCPE assessment outcome | The NCPE recommends that nivolumab in combination with ipilimumab be considered for reimbursement if 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 2021.
