Extended indication Extension of indication indicated in children 2 years of age and older for reduction in the duration
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
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)
Proprietary name Lonquex
Manufacturer Teva
Mechanism of action Other, see general comments
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional comments Granulocyte stimulant, haematopoiesis stimulant en neutrophil stimulant.

Registration

Registration route Centralised (EMA)
Submission date August 2020
Expected Registration July 2022
Orphan drug No
Registration phase Registered and reimbursed
Additional comments Positieve CHMP opinie ontvangen op juni 2022.

Therapeutic value

Current treatment options Pegfilgrastim
Therapeutic value No estimate possible yet
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.

Expected patient volume per year

Patient volume

< 600

Market share is generally not included unless otherwise stated.

Additional comments 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
References medicijnkosten.nl; GIPdatabank
Additional comments 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

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.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.