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. Therapeutic value No judgement Total cost Registration phase Registration application pending 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. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Advanced Accelerator Applications Portfolio holder Mechanism of action Unknown 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 August 2019 Orphan drug Unknown Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks 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 Duration of treatment Frequency of administration 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 References medicijnkosten.nl Additional remarks De prijs van 1 infusiezak lysine/arginine 25/25mg/ml voor een zak van 1000 ml € 41,95. Mogelijk zal een registratie voor deze specifieke indicatie een prijsstijging met zich meebrengen. Potential total cost per year Total cost 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