National Centre for Pharmacoeconomics

National Centre for

NCPE Ireland

Nivolumab (Opdivo®) as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy.

NCPE assessment process
Rapid review received 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
Submission received from applicant 22/01/2018
Preliminary review sent to applicant 25/04/2018
NCPE assessment re-commenced 15/06/2018
Preliminary review II sent to applicant 13/07/2018
NCPE assessment re-commenced 30/07/2018
Preliminary review III 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. This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.