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

Positive CHMP opinion

Product

Active substance

Liraglutide

Domain

Metabolism and Endocrinology

Reason of inclusion

Indication extension

Main indication

Other metabolism and Endocrinology

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 60 kg and obesity (BMI corresponding to ≥30 kg/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

Extramural (GVS)

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

Positive CHMP opinion

Additional comments
Positieve CHMP-opinie in maart 2021.

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.