Extended indication Extension of indication to include treatment of the paediatric population for Lonquex and introducti
Therapeutic value No estimate possible yet
Total cost 1,926,600.00
Registration phase Registration application pending

Product

Active substance Lipegfilgrastim
Domain Oncology and Hematology
Reason of inclusion Indication extension
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.
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 2022
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet

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.

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.