| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 22046 |
| Drug | Nivolumab |
| Brand | Opdivo® |
| Indication | Is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (MIUC) with tumour cell PD-L1 expression ≥1%, who are at high risk of recurrence after undergoing radical resection of MIUC. |
| Assessment Process | |
| Rapid review commissioned | 01/07/2022 |
| Rapid review completed | 08/08/2022 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of nivolumab for this indication compared with the current standard of care |
| Full pharmacoeconomic assessment commissioned by HSE | 31/08/2022 |
| Pre-submission consultation with Applicant | 29/11/2022 |
| Full submission received from Applicant | 21/02/2023 |
| Preliminary review sent to Applicant | 02/10/2023 |
| NCPE assessment re-commenced | 01/11/2023 |
| Factual accuracy sent to Applicant | 21/12/2023 |
| NCPE assessment re-commenced | 12/01/2024 |
| NCPE assessment completed | 21/02/2024 |
| NCPE assessment outcome | The NCPE recommends that nivolumab (Opdivo®) 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.
