Semaglutide Medicine 05 December 2023 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 Total cost Registration phase Registration application pending Product Active substance Semaglutide Domain Metabolism and Endocrinology Reason of inclusion Indication extension IND 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. Current proprietary name Already available biosimilars / generics Proprietary name Wegovy 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 Unknown Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date October 2023 Expected Registration August 2024 Orphan drug Unknown Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks 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 Dosage per administration 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. 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 € 1,400.00 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 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. 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