Setmelanotide Medicine 03 June 2025 Extended indication Extension of indication to include reduction in hunger (or hyperphagia) and BMI/BMI z-score, improvement of metabolic parameters, and increase in energy expenditure in adults and children 4 years of age and above, following rapid and severe weight gain associated with hypothalamic injury and/or impairment. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Setmelanotide Domain Metabolism and Endocrinology Reason of inclusion Indication extension IND Main indication Other metabolism and Endocrinology Extended indication Extension of indication to include reduction in hunger (or hyperphagia) and BMI/BMI z-score, improvement of metabolic parameters, and increase in energy expenditure in adults and children 4 years of age and above, following rapid and severe weight gain associated with hypothalamic injury and/or impairment. Current proprietary name Already available biosimilars / generics Proprietary name Imcivree Manufacturer Rhythm Portfolio holder Mechanism of action 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 ATMP No Submission date August 2025 Expected Registration March 2026 Orphan drug Yes Registration phase Registration application pending 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 Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks