Lutetium (177Lu) edotreotide Medicine 03 December 2024 Extended indication Lutetium (177Lu) edotreotide monotherapy for first line treatment of inoperable, progressive grade 1 and 2, somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumour disease in adults and elderly. Therapeutic value No estimate possible yet Total cost € 45,201,600.00 Registration phase Clinical trials Product Active substance Lutetium (177Lu) edotreotide Domain Oncology Reason of inclusion New medicine (specialité) Main indication Neuroendocrine cancer Extended indication Lutetium (177Lu) edotreotide monotherapy for first line treatment of inoperable, progressive grade 1 and 2, somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumour disease in adults and elderly. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Itm Portfolio holder Mechanism of action Other, see general comments Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Lutetium (177Lu) edotreotide is een radioconjugaat dat bestaat uit edotreotide gelabeld met lutetium-177. Lutetium (177Lu) edotreotide bindt aan somatostatine receptoren (SSTRs), met hoge affiniteit voor type 2 SSTR, dat aanwezig is op de celmembranen van veel typen neuro-endocrine tumorcellen. Na binding en internalisering levert dit radioconjugaat specifiek een cytotoxische dosis bètastraling aan SSTR-positieve cellen. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date June 2026 Expected Registration July 2027 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Tijdlijn op basis van IHSI-inschatting. 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 1 year / years Frequency of administration 1 times every 3 months Dosage per administration 7,5 ± 0,7 GBq References NCT03049189 (COMPETE) Additional remarks Maximaal vier cycli van 7,5 ± 0,7 GBq (gigabequerel) 177Lu-edotreotide. Expected patient volume per year Patient volume < 516 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2022 (1); Das & Dasari. Curr Oncol Rep. 2021 (2); Fazio & Milione. The Oncologist. 2017 (3). Additional remarks Jaarlijks krijgen in Nederland ruim 900 mensen een neuro-endocrine tumor (NET) (1). 55 tot 70% van NETs zijn gastro-enteropancreatische NETs (GEP-NETs) (2). 82% van GEP-NETs zijn graad 1 of 2 (3). Het is niet bekend hoeveel graad 1 of 2 GEP-NETs inoperabel zijn. Expected cost per patient per year Cost € 87,600.00 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 Additional remarks De kosten zullen mogelijk vergelijkbaar zijn met pluvicto €87.570 per patiënt per jaar. Potential total cost per year Total cost € 45,201,600.00 Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks