Nivolumab Medicine 09 January 2018 Extended indication Mesothelioom (in combinatie met ipilimumab). Therapeutic value No judgement Total cost € 28,350,000.00 Registration phase Clinical trials Product Active substance Nivolumab Domain Oncology and Hematology Reason of inclusion Main indication Mesothelioma Extended indication Mesothelioom (in combinatie met ipilimumab). Current proprietary name Already available biosimilars / generics Proprietary name Opdivo Manufacturer BMS Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks PD-1 antilichaam. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Indication extension ATMP Unknown Submission date Expected Registration October 2020 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Alle PD1 en PDL1 remmers worden verwacht voor deze indicatie (Pembrolizumab, Atezolizumab) 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 < 567 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks NKR 2016: 567 diagnoses pleuramesothelioom. Expected cost per patient per year Cost € 40,000.00 - 60,000.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References G-standaard Additional remarks €1.036 voor 10 ml van 10 mg/ml en €414,30 voor 4 ml van 10 mg/ml. Potential total cost per year Total cost € 28,350,000.00 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