Exenatide Medicine 12 June 2018 Extended indication Bydureon is a diabetes medicine used together with other diabetes medicines including long-acting insulin to treat adults with type 2 diabetes whose blood glucose (sugar) levels are not adequately controlled with the other medicines Therapeutic value No judgement Total cost € 1,352,000.00 Registration phase Registered and reimbursed Product Active substance Exenatide Domain Metabolism and Endocrinology Reason of inclusion New medicine (specialité) Main indication Diabetes Extended indication Bydureon is a diabetes medicine used together with other diabetes medicines including long-acting insulin to treat adults with type 2 diabetes whose blood glucose (sugar) levels are not adequately controlled with the other medicines 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. Verder identiek aan huidige product. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity New therapeutical formulation ATMP Unknown Submission date January 2018 Expected Registration August 2018 Orphan drug Unknown Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in juni 2018. Geregistreerd in augustus 2018 Therapeutic value Current treatment options exenatide huidige injector 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 In 2017 988 gebruikers op exenatide. Dit aantal is afnemend ten opzichte van voorgaande jaren. Totale GLP-1 klasse in 2017 volgens GIP 12.919 gebruikers. Het gebruik van exenatide zal naar verwachting nog verder afnemen nu semaglutide ook beschikbaar is. De verwachting is dat deze formulering een zeer klein segment van de huidige markt voor exenatide overneemt. Inschatting: er komen maximaal 1000 patiënten in aanmerking. Expected cost per patient per year Cost € 1,352.00 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 NHG- 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 € 1,352,000.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks