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 Unknown Centre of expertise Additional remarks Registration Registration route Unknown Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown 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 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 References Additional remarks 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