Lutetium (177Lu) oxodotreotide Medicine 09 January 2018 Extended indication Lutathera is geïndiceerd voor de behandeling van niet-resecteerbare of gemetastaseerde, progressieve, goed gedifferentieerde (G1 en G2), somatostatinereceptor-positieve gastro-entero-pancreatische neuroendocriene tumoren (GEP-NET's) bij volwassenen. Therapeutic value Possible added value Total cost € 36,708,000.00 Registration phase Registered Product Active substance Lutetium (177Lu) oxodotreotide Domain Oncology and Hematology Reason of inclusion Main indication Neuroendocrine cancer Extended indication Lutathera is geïndiceerd voor de behandeling van niet-resecteerbare of gemetastaseerde, progressieve, goed gedifferentieerde (G1 en G2), somatostatinereceptor-positieve gastro-entero-pancreatische neuroendocriene tumoren (GEP-NET's) bij volwassenen. Current proprietary name Already available biosimilars / generics Proprietary name Lutathera Manufacturer Novartis Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Lutathera is a radiolabeled somatostatin analog that selectively targets somatostatin receptors which are over-expressed in some tumour types. Aanvankelijk geproduceerd door Advanced Accelerator Applications (AAA), overgenomen door Novartis. Registration Registration route Centralised (EMA) Type of trajectory Accelerated assessment Particularity New medicine ATMP Unknown Submission date April 2016 Expected Registration September 2017 Orphan drug Yes Registration phase Registered Reimbursement Medicine sluice Additional remarks Gergistreerd in september 2017, nog geen vergoeding in Nederland. Therapeutic value Current treatment options Wordt nu magistraal door ziekenhuizen (2 in Nederland) zelf bereid. Substitutie met Sunitinib en Everolimus. Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times every 8 weeks Dosage per administration 7.400 MBq References Additional remarks In totaal 4 toedieningen. 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 € 92,000.00 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 Reuters, 26 januari 2018; G-standaard Additional remarks De kosten in de VS bedragen $47.500 per dosis en dus $190.000 per behandeling. In Nederland zal het waarschijnlijk €92.000 per patiënt bedragen. Potential total cost per year Total cost € 36,708,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks