Ramucirumab Medicine 12 June 2018 Extended indication Extension of Indication to include Cyramza indicated as monotherapy for the treatment of adult patients with hepatocellular carcinoma who have an alpha fetoprotein (AFP) of ≥ 400 ng/mL, after prior sorafenib therapy. Therapeutic value No judgement Total cost € 532,000.00 Registration phase Registration application pending Product Active substance Ramucirumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Liver cancer Extended indication Extension of Indication to include Cyramza indicated as monotherapy for the treatment of adult patients with hepatocellular carcinoma who have an alpha fetoprotein (AFP) of ≥ 400 ng/mL, after prior sorafenib therapy. Current proprietary name Already available biosimilars / generics Proprietary name Cyramza Manufacturer Eli Lilly Portfolio holder Mechanism of action Angiogenesis inhibitor 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 Normal trajectory Particularity Unknown ATMP Unknown Submission date August 2018 Expected Registration August 2019 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Lilly geeft aan dat de indiening mid 2018 zal plaatsvinden. Therapeutic value Current treatment options Regorafenib Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Patiënten met AFP-High hebben een verbetering van de mediane OS van 3,1 maand. Duration of treatment Median 3 month / months Frequency of administration 1 times every 2 weeks Dosage per administration 8 mg/kg References 2018 ASCO annual meeting abstract #4003; NCT02435433; Zhu et al. Lancet Oncol. 2019 Jan 18. Additional remarks 8 mg/kg ramucirumab wordt toegediend via IV op dag 1 van iedere cyclus van 14 dagen. Expected patient volume per year Patient volume 20 - 50 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 20-50 patiënten hiervan in de tweede lijn zullen worden behandeld. Expected cost per patient per year Cost € 15,200.00 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 Fabrikant; Zhu et al. Lancet Oncol. 2019 Feb;20(2):282-296. G-standaard Additional remarks AIP mei 2019: €453,46 voor een flacon van 100 mg. Voor een patiënt van 70 kg worden 5,6 flacons per cyclus gebruikt (€2.539,38). Het mediaan aantal cycli bedraagt 6 dus de totale kosten zijn €15.236,26. Potential total cost per year Total cost € 532,000.00 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