| Assessment Status | Assessment Process Complete |
| HTA ID | - |
| Drug | Nivolumab |
| Brand | Opdivo® |
| Indication | As monotherapy for the adjuvant treatment of adults with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. |
| Assessment Process | |
| Rapid review commissioned | 09/07/2018 |
| Rapid review completed | 27/07/2018 |
| 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 | 01/08/2018 |
| Pre-submission consultation with Applicant | 03/09/2018 |
| Full submission received from Applicant | 30/11/2018 |
| Preliminary review sent to Applicant | 26/03/2019 |
| NCPE assessment re-commenced | 25/04/2019 |
| Factual accuracy sent to Applicant | 10/09/2019 |
| NCPE assessment re-commenced | 17/09/2019 |
| NCPE assessment completed | 13/10/2019 |
| NCPE assessment outcome | The NCPE recommends that nivolumab 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.
