Dulaglutide Medicine 07 December 2022 Extended indication Extension of indication to include treatment of type 2 diabetes mellitus (T2DM) in children and adolescents aged 10 to less than 18 years Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Dulaglutide Domain Metabolism and Endocrinology Reason of inclusion Indication extension IND Main indication Diabetes Extended indication Extension of indication to include treatment of type 2 diabetes mellitus (T2DM) in children and adolescents aged 10 to less than 18 years Current proprietary name Already available biosimilars / generics Proprietary name Trulicity Manufacturer Eli Lilly Portfolio holder Mechanism of action Unknown Route of administration Intramuscular Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks GLP1-agonist Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date July 2022 Expected Registration May 2023 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 NCT02963766 Additional remarks Participants received 0,75mg/week or 1,5 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 1,5mg/week for 26 weeks during the study. 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 € < 802.00 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 GIPdatabank Additional remarks In 2021 werd er per volwassen gebruiker €802,20 vergoed. 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