Nivolumab (Opdivo®) for muscle invasive urothelial carcinoma. HTA ID: 22046

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*.

Technical Summary

Plain English Summary

* This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.