Insulin glargine Medicine 10 December 2019 Extended indication Extension of indication to include new population for Toujeo (i.e. adolescents and children from the age of 6 years). Therapeutic value No judgement Total cost Registration phase Registered and reimbursed Product Active substance Insulin glargine Domain Metabolism and Endocrinology Reason of inclusion Indication extension IND Main indication Diabetes Extended indication Extension of indication to include new population for Toujeo (i.e. adolescents and children from the age of 6 years). Current proprietary name Already available biosimilars / generics Proprietary name Toujeo Manufacturer Sanofi Portfolio holder Mechanism of action Receptor agonist Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Insulin receptor agonists Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date April 2019 Expected Registration January 2020 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in oktober 2019. Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation De data bij volwassenen wijzen uit dat het geneesmiddel een meerwaarde heeft. De glucosewaarden zijn stabieler en er is een beter afgifte patroon waardoor het werkingsmechanisme langer is. Echter, is de data bij kinderen nog beperkt en lopen de trials nog op dit moment. Duration of treatment Frequency of administration 1 times a day Dosage per administration 300 U/ml References farmacotherapeutisch kompas Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References https://www.volksgezondheidenzorg.info/onderwerp/diabetes-mellitus/cijfers-context/huidige-situatie#node-prevalentie-diabetes-bij-kinderen-en-jongeren Additional remarks Aantal kinderen met diabetes mellitus is zeer beperkt, verwachting dat toepassing in deze populatie minimaal is. Informatie over prevalentie van diabetes bij kinderen en jongeren is schaars. Expected cost per patient per year Cost € 360.00 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 GIP databank Additional remarks Huidige kosten per patiënt per jaar voor insuline glargine betreffen zo'n €360. 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