Liraglutide Medicine 03 December 2024 Extended indication Children (6 to <12 years): Saxenda is indicated as an adjunct to healthy nutrition and increased physical activity for weight management in children from the age of 6 to <12 years with obesity (BMI ≥95th percentile)* and body weight ≥45 kg Treatment with Saxenda should be discontinued and re-evaluated if patients have not lost at least 4% of their BMI or BMI z score after 12 weeks on the 3.0 mg/day or maximum tolerated dose. *CDC BMI cut-off points for obesity (≥95th percentile) by sex between 6 to <12 years (see table 2), in accordance with study design of the Trial 4392, see section 5.1. Therapeutic value Possible added value Total cost Registration phase Registered Product Active substance Liraglutide Domain Metabolism and Endocrinology Reason of inclusion Indication extension IND Main indication Metabolic diseases Extended indication Children (6 to <12 years): Saxenda is indicated as an adjunct to healthy nutrition and increased physical activity for weight management in children from the age of 6 to <12 years with obesity (BMI ≥95th percentile)* and body weight ≥45 kg Treatment with Saxenda should be discontinued and re-evaluated if patients have not lost at least 4% of their BMI or BMI z score after 12 weeks on the 3.0 mg/day or maximum tolerated dose. *CDC BMI cut-off points for obesity (≥95th percentile) by sex between 6 to <12 years (see table 2), in accordance with study design of the Trial 4392, see section 5.1. Current proprietary name Already available biosimilars / generics Proprietary name Saxenda Manufacturer Novo Nordisk Portfolio holder Mechanism of action GLP-1 receptor agonist 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 2024 Expected Registration June 2025 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in mei 2025. Therapeutic value Current treatment options Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation De SCALE KIDS liet een verlaging van 7,4% afname in BMI ten opzichte van placebo met een gecombineerde leefstijlinterventie (GLI) zien. Duration of treatment Frequency of administration 1 times a day Dosage per administration 3 mg References NCT04775082 (SCALE KIDS); Fox et al. NEJM. 2025. Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIPdatabank (1); Expertopinie (2). Additional remarks In 2023 waren er 23.675 gebruikers van Saxenda (1). Het volume hangt af van de voorwaarden die aanvullend gesteld zullen worden. De huidige vergoeding bij volwassenen is als zij een gecombineerde leefstijlinterventie (GLI) hebben doorlopen en onvoldoende zijn afgevallen na negen maanden en bij aanvang een BMI kleiner dan 35 hadden. Wellicht dat dit ook voor kinderen gaat gelden, het betreft dan nog steeds een beperkte groep (2). Expected cost per patient per year Cost € < 1,200.00 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 GIPdatabank (1) Additional remarks In 2023 werd er per patiënt €1.128 vergoed voor het gebruik van liraglutide (1). 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