Extended indication Extension of indication to include treatment as an adjunct to a healthy nutrition and physical activ
Therapeutic value No estimate possible yet
Registration phase Registered

Product

Active substance Liraglutide
Domain Metabolism and Endocrinology
Reason of inclusion Indication extension
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).
Proprietary name Saxenda
Manufacturer Novo Nordisk
Mechanism of action GLP-1 receptor agonist
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional comments GLP-1 analoog

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date February 2020
Expected Registration June 2021
Orphan drug No
Registration phase Registered
Additional comments 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

Therapeutic value No estimate possible yet
Frequency of administration 1 times a day
References NCT02918279

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

Cost 1,175.00
References GIPdatabank
Additional comments In 2018 werd er per patiënt €1.175 vergoed voor het gebruik van liraglutide.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.