Methoxy polyethylene glycol-epoetin beta

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

Therapeutic value	No estimate possible yet
References	NCT03552393

There is currently nothing known about the expected patient volume.

Cost	< 1,278.00
References	medicijnkosten.nl; GIP-databank
Additional remarks	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.

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.