Liraglutide Medicine 03 December 2024 Extended indication Extension of indication to include the use of SAXENDA for weight management in children from the age of 6 years to less than 12 years Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Liraglutide Domain Metabolism and Endocrinology Reason of inclusion Indication extension IND Main indication Metabolic diseases Extended indication Extension of indication to include the use of SAXENDA for weight management in children from the age of 6 years to less than 12 years 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 Unknown ATMP No Submission date August 2024 Expected Registration March 2025 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Verwachte registratie 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 Frequency of administration 1 times a day Dosage per administration 3 mg References NCT04775082 (SCALE KIDS) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost € 1,128.00 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 Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks