L-lysine / L-arginine Medicine 13 December 2018 Extended indication Reduction of renal radiation exposure during peptide-receptor radionuclide therapy (PRRT) with lutetium (177Lu) oxodotreotide in adults. Therapeutic value No judgement Total cost € 239,400.00 Registration phase Positive CHMP opinion Product Active substance L-lysine / L-arginine Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Neuroendocrine cancer Extended indication Reduction of renal radiation exposure during peptide-receptor radionuclide therapy (PRRT) with lutetium (177Lu) oxodotreotide in adults. Current proprietary name Already available biosimilars / generics Proprietary name Lyskare Manufacturer Advanced Accelerator Applications Portfolio holder Mechanism of action Amino acid Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Advanced Accelerator Applications Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity New therapeutical formulation ATMP Unknown Submission date July 2018 Expected Registration July 2019 Orphan drug No Registration phase Positive CHMP opinion Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie mei 2019. Therapeutic value Current treatment options Geen, het is een extra behandeloptie bij Lu-177 dotatate om de nieren te beschermen Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Mogelijke meerwaarde in latere lijns behandeling Duration of treatment Average 24 week / weeks Frequency of administration 1 times every 8 weeks Dosage per administration References http://www.ascopost.com/issues/march-10-2018/lutetium-lu-177-dotatate-in-gastroenteropancreatic-neuroendocrine-tumors/ Additional remarks 30 minuten voor de behandeling met Lu-177 dotatate dient L-lysine / L-arginine te worden gegeven Expected patient volume per year Patient volume < 399 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks NKR 2015: 399 neuroendocriene tumoren stadium 4. Expected cost per patient per year Cost € 600.00 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 Additional remarks €150 euro per 1.000 ml. Een behandeling is bestaat uit 4 toedieningen, in totaal dus €600 per patiënt per jaar. De fabrikant overweegt bij bestelling van Lutathera Lysakare gratis bij te leveren. Potential total cost per year Total cost € 239,400.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Mogelijk uitbreiding naar prostaatkanker indien Lutathera ook naar deze indicatie wordt uitgebreid. References Additional remarks Other information Additional remarks