Nivolumab (Opdivo®) as monotherapy for the adjuvant treatment of adults with melanoma

Assessment Status Assessment Process Complete
Drug Nivolumab
Brand Opdivo®
Indication As monotherapy for the adjuvant treatment of adults with melanoma  with involvement of lymph nodes or metastatic disease who have undergone complete resection.
Assessment Process
Rapid review commissioned 09/07/2018
Rapid review completed 27/07/2018
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 01/08/2018
Pre-submission consultation with Applicant 03/09/2018
Full submission received from Applicant 30/11/2018
Preliminary review sent to Applicant 26/03/2019
NCPE assessment re-commenced 25/04/2019
Factual accuracy sent to Applicant 10/09/2019
NCPE assessment re-commenced 17/09/2019
NCPE assessment completed 13/10/2019
NCPE assessment outcome The NCPE recommends that nivolumab be considered for reimbursement if 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 February 2021.