Setmelanotide Medicine 03 June 2025 Extended indication Setmelanotide monotherapy for treatment of acquired hypothalamic obesity in children over 4 years of age, adolescents, adults and elderly. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Setmelanotide Domain Metabolism and Endocrinology Reason of inclusion Indication extension IND Main indication Other metabolism and Endocrinology Extended indication Setmelanotide monotherapy for treatment of acquired hypothalamic obesity in children over 4 years of age, adolescents, adults and elderly. Current proprietary name Already available biosimilars / generics Proprietary name Imcivree Manufacturer Rhythm Portfolio holder Mechanism of action Unknown Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date 2025 Expected Registration February 2026 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks 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 Expertopinie; Setmelanotide in patients aged 2–5 years with rare MC4R pathway-associated obesity (VENTURE): a 1 year, open-label, multicenter, phase 3 trial. J Argente, CF Verge, U Okorie, I Fennoy The Lancet Diabetes 2025; NCT05774756 (TRANSCEND) Additional remarks 2 punten BMI daling bij >80% van de patiënten. In het algemeen lijkt het een toevoeging. Als geheel wel iets om in de gaten te houden. Kinderen die geen verzadigingsgevoel hebben, is een hele ernstige aandoening. Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Expertopinie Additional remarks Het betreft hier waarschijnlijk enkele tientallen kinderen. Expected cost per patient per year Cost € 50,000.00 - 200,000.00 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 Medicijnkosten.nl Additional remarks De gemiddelde prijs van een injectieflacon IMCIVREE, 1ml injectievloeistof 10mg/ml is € 2.997,50 inclusief btw. In de klinische studie wordt een dosis van 0,5 tot 2mg genoemd. 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