Ramucirumab Medicine 12 June 2018 Extended indication 2nd line hepatocellular cancer Therapeutic value No judgement Total cost € 4,500,000.00 Registration phase Clinical trials Product Active substance Ramucirumab Domain Oncology and Hematology Reason of inclusion Main indication Liver cancer Extended indication 2nd line hepatocellular cancer Current proprietary name Already available biosimilars / generics Proprietary name Cyramza Manufacturer Eli Lilly Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Monoclonaal antilichaan gericht tegen VEGF2. Ramucirumab blokkeert de binding van VEGF aan VEGFR2 en remt zo de angiogenese. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Indication extension ATMP Unknown Submission date Expected Registration Orphan drug Unknown Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Sorafenib Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Median 6 month / months Frequency of administration 1 times every 2 weeks Dosage per administration References NCT01140347; Llovet et al. N Engl J Med 2008; 359:378-390 Additional remarks Voor Sorafenib was de mediane behandelduur ongeveer 6 maanden Expected patient volume per year Patient volume < 100 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks Totaal aantal patiënten in 2016 met hepatocellulair carcinoom stadium 4 betreft 158. Verwacht wordt dat ongeveer 100 patiënten hiervan in de tweede lijn zullen worden behandeld. Expected cost per patient per year Cost € 40,000.00 - 50,000.00 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 Flacon 100 mg Ramacirumab kost €572,39; Uitgaande van een patient van 70 kg en een behandelduur van 6 maanden komt dit neer op €41.784,43 Potential total cost per year Total cost € 4,500,000.00 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