Nivolumab Medicine 09 January 2018 Extended indication Adjuvant melanoma stage III - post-resection adjuvant therapy in high-risk patients. Therapeutic value No judgement Total cost € 50,700,000.00 Registration phase Unknown Product Active substance Nivolumab Domain Oncology and Hematology Reason of inclusion Main indication Skin cancer Extended indication Adjuvant melanoma stage III - post-resection adjuvant therapy in high-risk patients. 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 Financieel arrangement van toepassing op alle indicaties. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date Expected Registration June 2018 Orphan drug No Registration phase Unknown Reimbursement Medicine sluice Additional remarks Dit is een indicatie-uitbreiding. Therapeutic value Current treatment options Ipilimumab Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 2 times a month Dosage per administration 3 mg/kg References Weber et al. N Engl J Med. 2017 Nov 9;377(19):1824-1835 Additional remarks Toedieningsfrequentie is 1 maal per 2 weken. Expected patient volume per year Patient volume < 1,014 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Oncoline Additional remarks NKR 2015: 1014 diagnoses stadium 2. Oncoline: Er wordt geadviseerd om patiënten met melanoom buiten onderzoeksverband geen systemisch adjuvante behandeling te geven. 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 Medicijnkosten.nl Additional remarks 10 mg/ml flacon 10 ml kost €1.098,16. Maximum uitgaande van 12 maanden behandeling van een volwassene van 70 kg. Potential total cost per year Total cost € 50,700,000.00 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