Expand all sections

Methoxy polyethylene glycol-epoetin beta

Mircera

Extended indication Treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in paediatric patients
Therapeutic value Possible benefit in ease of use
Registration phase Registered and reimbursed

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 Treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in paediatric patients from 3 months to less than 18 years of age who are converting from another erythropoietin stimulating agent (ESA) after their haemoglobin level was stabilised with the previous ESA.
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 August 2023
Orphan drug Yes
Registration phase Registered and reimbursed
Additional remarks Positieve CHMP-opinie juni 2023

Therapeutic value

Current treatment options EPO-stimulerende agentia
Therapeutic value Possible benefit in ease of use
Substantiation Voor kinderen met anemie door chronische nierziekten zijn EPO-stimulerende agentia (ESA) bewezen effectief. De langere halfwaardetijd van de CERA met injecties één keer per 4 weken en de optie voor subcutane injectie heeft een mogelijke meerwaarde in toedieningsgemak voor kinderen.
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 remarks 100MCG/ML wegwerpspuit 0,3ML Gemiddelde prijs per stuk €59,27. Voor volwassenen betreffen de kosten per patiënt per jaar €1.278 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.