Nivolumab (Opdivo®) for urothelial carcinoma

Assessment Status Assessment Process Complete
Drug Nivolumab
Brand Opdivo®
Indication As monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy.
Assessment Process
Rapid review commissioned 28/06/2017
Rapid review completed 10/08/2017
Rapid review outcome Full Pharmacoeconomic Assessment Recommended
Full pharmacoeconomic assessment commissioned by HSE 06/09/2017
Pre-submission consultation with Applicant 23/10/2017
Full submission received from Applicant 22/01/2018
Preliminary review sent to Applicant 25/04/2018
NCPE assessment re-commenced 15/06/2018
Follow-up to preliminary review sent to Applicant 13/07/2018
NCPE assessment re-commenced 30/07/2018
Additional follow-up to Preliminary Review sent to Applicant 31/07/2018
NCPE assessment re-commenced 10/08/2018
Factual accuracy sent to Applicant 17/08/2018
NCPE assessment re-commenced 31/08/2018
NCPE assessment completed 12/09/2018
NCPE assessment outcome The NCPE recommends that nivolumab (Opdivo®) not be considered for reimbursement.

Technical 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.