Extended indication Extension of indication to include treatment of paediatric patients from 3 months to less than 18 y
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Methoxy polyethylene glycol-epoetin beta
Domain Cardiovascular diseases
Reason of inclusion Indication extension
Main indication Other non-oncological hematological medications
Extended indication Extension of indication to include treatment of paediatric patients from 3 months to less than 18 years of age requiring dialysis or not yet on dialysis and switching from another ESA to Mircera.
Proprietary name Mircera
Manufacturer Roche
Route of administration Injection into the salivary glands
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
ATMP No
Submission date June 2022
Expected Registration July 2023
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet
References NCT03552393

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

Cost < 1,278.00
References medicijnkosten.nl; GIP-databank
Additional comments 100MCG/ML wegwerpspuit 0,3ML Gemiddelde prijs per stuk € 59,27. Voor volwassenen betreffen de kosten per patient per jaar 1.278,0 euro in 2021. Mogelijk zullen de kosten voor kinderen lager zijn indien een lagere dosering wordt gehanteerd.

Potential total cost per year

There is currently nothing known about the possible total cost.

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.