Insulin lispro Medicine 07 June 2022 Extended indication Extension of indication to include the treatment of diabetes mellitus in adolescents and children aged 1 year and above. Therapeutic value No estimate possible yet Total cost Registration phase Positive CHMP opinion Product Active substance Insulin lispro Domain Metabolism and Endocrinology Reason of inclusion Indication extension IND Main indication Diabetes Extended indication Extension of indication to include the treatment of diabetes mellitus in adolescents and children aged 1 year and above. Current proprietary name Already available biosimilars / generics Proprietary name Lyumjev Manufacturer Eli Lilly Portfolio holder Mechanism of action Insulin preparation Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Lyumjev is een formulering van insuline lispro die citraat en treprostinil bevat. Citraat verhoogt de lokale vasculaire permeabiliteit en treprostinil induceert lokale vaatverwijding om versnelde absorptie van insuline lispro te bereiken. (1b tekst lyumjev) Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date January 2022 Expected Registration December 2022 Orphan drug No Registration phase Positive CHMP opinion Reimbursement Medicine sluice Additional remarks Positieve CHMP opinie ontvangen 13 oktober 2022. 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 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Dit geneesmiddel wordt al bij kinderen van verschillende leeftijden toegepast (zie GIP-databank) het patiëntvolume dat extra zal worden behandeld door deze indicatie-uitbreiding lijkt dan ook beperkt. Expected cost per patient per year Cost References medicijnkosten.nl Additional remarks Lyumjev junior kwikpen injvlst 100e/ml pen 3ml prijs per pen betreft € 6,97 incl. BTW 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