Assessment Status |
Awaiting response from Applicant |
HTA ID |
21049 |
Drug |
Nivolumab |
Brand |
Opdivo® |
Indication |
Nivolumab is indicated in combination with fluoropyrimidine and platinum-based combination chemotherapy for the first line treatment of adult patients with HER2 negative advanced or metastatic gastric, gastro oesophageal junction or oesophageal adenocarcinoma whose tumours express PD-L1 with a combined positive score (CPS) ≥5. |
Rapid review commissioned |
01/11/2021 |
Rapid review completed |
29/11/2021 |
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 |
07/12/2021 |
Pre-submission consultation with Applicant |
01/02/2022 |
Full submission received from Applicant |
10/10/2022 |
Preliminary review sent to Applicant |
27/03/2023 |