Exenatide Medicine 12 June 2018 Extended indication Diabetes type 2 Therapeutic value No judgement Total cost € 1,350,000.00 Registration phase Registration application pending Product Active substance Exenatide Domain Metabolism and Endocrinology Reason of inclusion Main indication Diabetes Extended indication Diabetes type 2 Current proprietary name Already available biosimilars / generics Proprietary name Bydureon BCise Manufacturer AstraZeneca Portfolio holder Mechanism of action Unknown Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks GLP-1 agonist, nieuwe injector voor extended release. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity New therapeutical formulation ATMP Unknown Submission date January 2018 Expected Registration November 2018 Orphan drug Unknown Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Exenatide Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times a week Dosage per administration 2 mg References Fabrikant Additional remarks Expected patient volume per year Patient volume 1,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Fabrikant; GIPdatabank Additional remarks 1,175 gebruikers op exenatide in 2016, dit is aantal is afnemend ten opzicht van voorgaande jaren. Totale GLP-1 klasse in 2016 volgens GIP 11.547 gebruikers. Verwacht wordt dat Bydureon BCise een klein segment van de huidige glp-1 markt overneemt. Expected cost per patient per year Cost € 1,300.00 - 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 G-standaard; Fabrikant Additional remarks Laag financieel risico, ongeveer gelijk aan huidige prijs bydureon pen (€26 per stuk). Als de NGH standaard diabetes glp-1 agonisten opneemt in het behandelalgoritme dan zal de commissie de voorkeur laten uitgaan naar middelen die een vermindering van cardiovasculaire events hebben laten zien. De cardiovasculaire outcome trial van dit middel heeft dat niet laten zien. Potential total cost per year Total cost € 1,350,000.00 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