Liraglutide Medicine 10 June 2020 Extended indication Extension of indication to include treatment as an adjunct to a healthy nutrition and physical activity counselling for weight management in adolescent patients from the age of 12 years and above with body weight above 60kg and obesity (BMI corresponding to ≥30kg/m2 for adults). Therapeutic value No estimate possible yet 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 Extension of indication to include treatment as an adjunct to a healthy nutrition and physical activity counselling for weight management in adolescent patients from the age of 12 years and above with body weight above 60kg and obesity (BMI corresponding to ≥30kg/m2 for adults). 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 Unknown Submission date February 2020 Expected Registration June 2021 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in maart 2021. Publicatie van GVS-advies wordt verwacht in februari 2022. Zorginstituut Nederland heeft beoordeeld of liraglutide (Saxenda®) kan worden opgenomen in het Geneesmiddelenvergoedingssysteem (GVS). Dit medicijn kan worden gebruikt voor de behandeling van (ernstig) overgewicht. Het Zorginstituut adviseert de minister van minister van Volksgezondheid, Welzijn en Sport (VWS) de vergoedingsvoorwaarden van liraglutide uit te breiden: de zogeheten bijlage 2-voorwaarden, voor volwassenen. Voor 12 en ouder dient nog een beoordeling plaats te vinden. 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 References NCT02918279 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 € 1,175.00 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 Additional remarks In 2018 werd er per patiënt €1.175 vergoed voor het gebruik van liraglutide. 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