Lutetium (177Lu) oxodotreotide Medicine 03 December 2024 Extended indication Lutetium (177lu) oxodotreotide in combination with long-acting octreotide for first line treatment of metastasized or locally advanced, inoperable, well differentiated Grade 2 or Grade 3 somatostatin receptor-expressing gastroenteropancreatic neuroendocrine tumour disease in adolescents over 15 years of age, adults and elderly Therapeutic value No estimate possible yet Total cost € 6,653,375.00 Registration phase Registration application pending Product Active substance Lutetium (177Lu) oxodotreotide Domain Oncology Reason of inclusion Indication extension IND Main indication Neuroendocrine cancer Extended indication Lutetium (177lu) oxodotreotide in combination with long-acting octreotide for first line treatment of metastasized or locally advanced, inoperable, well differentiated Grade 2 or Grade 3 somatostatin receptor-expressing gastroenteropancreatic neuroendocrine tumour disease in adolescents over 15 years of age, adults and elderly 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. Dit is de indicatieuitbreiding in combinatie met long-acting octreotide. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date June 2024 Expected Registration July 2025 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks EMA-indiening in juni 2024. Fabrikant verwacht registratie in juli 2025. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Average 24 week / weeks Frequency of administration 1 times every 8 weeks Dosage per administration 7.400 MBq References Horizonscan record Lutetium (177Lu) oxodotreotide. 2018 (1); NCT03972488 (NETTER-2) (2). Additional remarks Het aanbevolen behandelingsschema voor Lutathera bij volwassenen bestaat uit 4 infusies van elk 7.400 MBq. Het aanbevolen interval tussen elke toediening is 8 weken, hetgeen kan worden verlengd tot 16 weken in geval van toxiciteit waarvoor de dosis moet worden aangepast (1). Expected patient volume per year Patient volume 74 - 95 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2022 (1); Fazio & Milione. The Oncologist. 2017 (2); Das & Dasari. Curr Oncol Rep. 2021 (3). Additional remarks Jaarlijks krijgen in Nederland ruim 900 mensen een neuro-endocrine tumor (NET) (1). Deze indicatieuitbreiding is voorlopig voor de toevoeging van graad 3 tumoren aan het label. 18% van NETs zijn graad 3 (2). 55-70% van NETs zijn gastro-entero-pancreatische NETs (3). Expected cost per patient per year Cost € 78,275.00 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 (1); SmPC (2) Additional remarks De huidige AIP van Lutathera infusievloeistof 370MBq/ml flacon 20,5-25ml is €19.568,78 (1). Eén flacon is voldoende voor een eenmalige toediening van 7.400MBq (2). Bij vier toedieningen zijn de totale kosten €78.275. Potential total cost per year Total cost € 6,653,375.00 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