Lipegfilgrastim Medicine 08 December 2020 Extended indication Extension of indication indicated in children 2 years of age and older for reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) Therapeutic value No estimate possible yet Total cost € 1,926,600.00 Registration phase Registered and reimbursed Product Active substance Lipegfilgrastim Domain Oncology Reason of inclusion Indication extension IND Main indication Oncology other Extended indication Extension of indication indicated in children 2 years of age and older for reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) 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 July 2022 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP opinie ontvangen op juni 2022. Therapeutic value Current treatment options Pegfilgrastim Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er lijkt niet direct een voordeel boven pegfilgrastim. Het veld is dan ook niet ontevreden over de werking van pegfilgrastim. De praktijk zal moeten uitwijzen of er mogelijk toch een voordeel aan gebruik van lipegfilgrastim is. 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. Er lijkt niet direct een voordeel boven pegfilgrastim. Daardoor wordt er verwacht dat het volume vooralsnog laag zal zijn. Expected cost per patient per year Cost € < 3,211.00 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 medicijnkosten.nl; GIPdatabank Additional remarks Lonquex, 0,6ml injectievloeistof 10mg/ml €1.024,05. In 2020 werd er per patiënt €3.211 vergoed. Potential total cost per year Total cost € 1,926,600.00 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