Semaglutide Medicine 03 June 2025 Extended indication Treatment of non-cirrhotic metabolic dysfunction-associated steatohepatitis with liver fibrosis 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 Liver diseases Extended indication Treatment of non-cirrhotic metabolic dysfunction-associated steatohepatitis with liver fibrosis Current proprietary name Already available biosimilars / generics Proprietary name 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 Unknown ATMP No Submission date March 2025 Expected Registration October 2025 Orphan drug No 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 NCT04822181 (ESSENCE) 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 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 Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks