Tirzepatide Medicine 04 December 2025 Extended indication Mounjaro is indicated for the treatment of adults, adolescents and children aged 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise - as monotherapy when metformin is considered inappropriate due to intolerance or contraindications - in addition to other medicinal products for the treatment of diabetes. Therapeutic value No estimate possible yet Total cost Registration phase Registered Product Active substance Tirzepatide Domain Metabolism and Endocrinology Reason of inclusion Indication extension IND Main indication Diabetes Extended indication Mounjaro is indicated for the treatment of adults, adolescents and children aged 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise - as monotherapy when metformin is considered inappropriate due to intolerance or contraindications - in addition to other medicinal products for the treatment of diabetes. Current proprietary name Already available biosimilars / generics Proprietary name Mounjaro Manufacturer Eli Lilly Portfolio holder Mechanism of action GLP-1 receptor agonist Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date July 2025 Expected Registration January 2026 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Indicatieuitbreiding van tirzepatide voor de behandeling van DM2 bij kinderen en adolescenten van 10 jaar en ouder is goedgekeurd per 22 januari 2026. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Eerste GLP-1 remmer voor deze groep. Geen voordelen op cardiovasculaire eindpunten. Liraglutide is superieur ondanks minder gewichtsverlies. Meer resultaten worden in 2026 verwacht. Duration of treatment Frequency of administration Dosage per administration References NCT05260021 (SURPASS-PEDS) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIPdatabank Additional remarks In 2024 waren er 1.978 gebruikers van tirzepatide (Mounjaro). Door deze indicatieuitbreiding naar tien jaar en ouder zal dit volume iets toenemen. Expected cost per patient per year Cost € < 500.00 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 2024 was de vergoeding per gebruiker van tirzepatide (Mounjaro) €452. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks