Semaglutide Medicine 03 June 2025 Extended indication Kayshild is indicated in conjunction with diet and exercise for the treatment of adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis (fibrosis stages F2 to F3). Therapeutic value No estimate possible yet Total cost Registration phase Registered Product Active substance Semaglutide Domain Metabolism and Endocrinology Reason of inclusion Indication extension IND Main indication Liver diseases Extended indication Kayshild is indicated in conjunction with diet and exercise for the treatment of adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis (fibrosis stages F2 to F3). Current proprietary name Already available biosimilars / generics Proprietary name Kayshild 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 ATMP No Submission date March 2025 Expected Registration March 2026 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in januari 2026. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De ESSENCE trial (fase 3 trial) met semaglutide 2.4mg heeft laten zien dat semaglutide effectief is in het verminderen van fibrose bij MASH bij gelijkblijvende MASH en/of het afnemen van MASH bij gelijkblijvende fibrose na 72 weken behandeling. Dit is effectiever dan bij resmetirom en als bijkomend voordeel heeft dat het gewichtsreductie geeft en positieve cardiovasculaire effecten. Duration of treatment Frequency of administration Dosage per administration References NCT04822181 (ESSENCE); N Engl J Med 2025;392:2089-2099). 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 De werkgroep verwacht dat dit de eerste keuze wordt bij patiënten met MASLD/MASH fibrose graad 2 en 3. Dit gaat om tienduizenden patiënten in Nederland. Ook zonder diabetes mellitus type 2 is het effectief gebleken. Expected cost per patient per year Cost € 1,400.00 - 2,900.00 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 13 pennen semaglutide (4 toedieningen van 0,5 mg) kosten in totaal €1.433,53. 26 pennen semaglutide (2 toedieningen van 1,0 mg) kosten in totaal €2.867,07 Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks