Semaglutide

Extended indication	Extension of indication to include risk reduction of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and BMI ≥27 kg/m2.
Therapeutic value	No estimate possible yet
Registration phase	Registration application pending

Product

Active substance	Semaglutide
Domain	Metabolism and Endocrinology
Reason of inclusion	Indication extension
Main indication	Other metabolism and Endocrinology
Extended indication	Extension of indication to include risk reduction of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and BMI ≥27 kg/m2.
Proprietary name	Wegovy
Manufacturer	Novo Nordisk
Mechanism of action	GLP-1 receptor agonist
Route of administration	Subcutaneous
Therapeutical formulation	Injection
Budgetting framework	Extramural (GVS)

Type of trajectory	Normal trajectory
ATMP	No
Submission date	October 2023
Expected Registration	August 2024
Registration phase	Registration application pending

Therapeutic value	No estimate possible yet
References	NCT04788511
Additional remarks	De resultaten van de SELECT trial zijn gepubliceerd en laten zien dat de behandeling van deze patiëntengroep de kans op een nieuw event met 20% verlaagt (on top of regular care). De daling van het lichaamsgewicht (10%) kan daarnaast ook gepaard gaan met andere gezondheidsvoordelen. Hier doet zich de algemene discussie voor over indicaties en vergoeding van gewicht verlagende medicatie.

There is currently nothing known about the expected patient volume.

Cost	1,400.00
References	Medicijnkosten.nl
Additional remarks	Voor Ozempic: 13 pennen semaglutide (4 toedieningen van 0,5mg) kosten in totaal €1.433,53. De prijs voor een pen met hogere dosis is gelijk. Kosten mogelijk vergelijkbaar voor orale tabletten.

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.