Methoxy polyethylene glycol-epoetin beta Medicine 07 December 2022 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. Therapeutic value Possible benefit in ease of use Total cost Registration phase Registered and reimbursed 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 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. 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 August 2023 Orphan drug Yes Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie juni 2023 Therapeutic value Current treatment options EPO-stimulerende agentia Therapeutic value Possible benefit in ease of use This assessment does not indicate any potential inclusion in the package. 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. 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 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 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