Etelcalcetide Medicine 03 June 2025 Extended indication Etelcalcetide in combination with standard of care for treatment of Hyperparathyroidism secondary in infants and toddlers, children and adolescents with chronic kidney disease receiving maintenance hemodialysis. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Etelcalcetide Domain Metabolism and Endocrinology Reason of inclusion Indication extension IND Main indication Unknown Extended indication Etelcalcetide in combination with standard of care for treatment of Hyperparathyroidism secondary in infants and toddlers, children and adolescents with chronic kidney disease receiving maintenance hemodialysis. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Amgen Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2025 Expected Registration November 2026 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks NCT03633708 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 Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References https://www.sciencedirect.com/science/article/abs/pii/S1521690X25000089?utm_source=chatgpt.com Additional remarks Hypoparathyreoïdie bij kinderen en adolescenten in Nederland is zeldzaam. Hoewel exacte cijfers ontbreken, wijzen internationale studies erop dat primaire hypoparathyreoïdie (PHPT) bij jongeren sporadisch voorkomt en vaak een genetische oorzaak heeft. Secundaire hypoparathyreoïdie (SHPT) bij kinderen kan optreden als gevolg van aandoeningen zoals vitamine D-tekort of chronische nierziekte, maar ook hiervoor zijn specifieke prevalentiecijfers in Nederland niet beschikbaar Expected cost per patient per year Cost References Additional remarks 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 Unknown Indication extensions References Additional remarks Other information Additional remarks