Lipegfilgrastim Medicine 08 December 2020 Extended indication Extension of indication to include treatment of the paediatric population for Lonquex and introduction of an age appropriate presentation in vials. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Lipegfilgrastim Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Oncology other Extended indication Extension of indication to include treatment of the paediatric population for Lonquex and introduction of an age appropriate presentation in vials. Current proprietary name Already available biosimilars / generics Proprietary name Lonquex Manufacturer Teva Portfolio holder Mechanism of action Other, see general comments Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Granulocyte stimulant, haematopoiesis stimulant en neutrophil stimulant. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date August 2020 Expected Registration June 2021 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 Additional remarks Expected patient volume per year Patient volume < 600 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Er zijn ongeveer 600 kinderen per jaar die gediagnosticeerd worden. Hiervan zal een gedeelte mogelijk behandeld worden. Expected cost per patient per year Cost References medicijnkosten.nl Additional remarks Lonquex, 0,6 ml injectievloeistof 10mg/ml €1.024,05. 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