| Assessment Status | Assessment Process Complete |
| HTA ID | 21023 |
| Drug | Nivolumab |
| Brand | Opdivo® |
| Indication | Nivolumab (Opdivo®) in combination with ipilimumab (Yervoy®) is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy. |
| Assessment Process | |
| Rapid review commissioned | 09/06/2021 |
| Rapid review completed | 17/06/2021 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of nivolumab in combination with ipilimumab compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 30/06/2021 |
| Pre-submission consultation with Applicant | 20/07/2021 |
| Full submission received from Applicant | 21/01/2022 |
| Preliminary review sent to Applicant | 02/08/2022 |
| NCPE assessment re-commenced | 29/09/2022 |
| Follow-up to preliminary review sent to Applicant | 14/10/2022 |
| NCPE assessment re-commenced | 03/11/2022 |
| Factual accuracy sent to applicant | 29/11/2022 |
| NCPE assessment re-commenced | 07/12/2022 |
| NCPE assessment completed | 19/12/2022 |
| NCPE assessment outcome | The NCPE recommends that NIVO+IPI 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.
