Nivolumab Medicine 09 January 2018 Extended indication Hepatocellular carcinoma after sorafenib (liver cancer) Therapeutic value No judgement Total cost Registration phase Unknown Product Active substance Nivolumab Domain Oncology and Hematology Reason of inclusion Main indication Liver cancer Extended indication Hepatocellular carcinoma after sorafenib (liver cancer) Current proprietary name Already available biosimilars / generics Proprietary name Opdivo Manufacturer BMS Portfolio holder Mechanism of action Unknown Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Unknown Centre of expertise Additional remarks Dit betreft een indicatie-uitbreiding. Registratieaanvraag teruggetrokken in september 2017. 'The company stated that despite the promising data shown for Opdivo in the treatment of hepatocellular carcinoma, uncertainties about the design of the main study did not allow the CHMP to conclude that the benefit outweighed the risk at the present time.' Registration Registration route Unknown Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date Expected Registration Orphan drug Unknown Registration phase Unknown Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks