Methoxy polyethylene glycol-epoetin beta Medicine 07 December 2022 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 Total cost Registration phase Registration application pending Product Active substance Methoxy polyethylene glycol-epoetin beta Domain Cardiovascular diseases Reason of inclusion Indication extension IND 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. Current proprietary name Already available biosimilars / generics Proprietary name Mircera Manufacturer Roche Portfolio holder Mechanism of action Unknown Route of administration Injection into the salivary glands Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date June 2022 Expected Registration July 2023 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT03552393 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost € < 1,278.00 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. 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. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks