| Assessment Status | Assessment Process Complete |
| HTA ID | - |
| Drug | Nivolumab |
| Brand | Opdivo® |
| Indication | As monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy. |
| Assessment Process | |
| Rapid review commissioned | 28/06/2017 |
| Rapid review completed | 10/08/2017 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Recommended |
| Full pharmacoeconomic assessment commissioned by HSE | 06/09/2017 |
| Pre-submission consultation with Applicant | 23/10/2017 |
| Full submission received from Applicant | 22/01/2018 |
| Preliminary review sent to Applicant | 25/04/2018 |
| NCPE assessment re-commenced | 15/06/2018 |
| Follow-up to preliminary review sent to Applicant | 13/07/2018 |
| NCPE assessment re-commenced | 30/07/2018 |
| Additional follow-up to Preliminary Review sent to Applicant | 31/07/2018 |
| NCPE assessment re-commenced | 10/08/2018 |
| Factual accuracy sent to Applicant | 17/08/2018 |
| NCPE assessment re-commenced | 31/08/2018 |
| NCPE assessment completed | 12/09/2018 |
| NCPE assessment outcome | The NCPE recommends that nivolumab (Opdivo®) not be considered for reimbursement. |
This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
