Nivolumab (Opdivo®) in combination with ipilimumab (Yervoy®) (Colorectal cancer). HTA ID: 21023

Assessment Status NCPE 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*.

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.

The HSE has approved reimbursement following confidential price negotiations; June 2023