Mirabegron Medicine 07 June 2022 Extended indication Treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 to less than 18 years. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Mirabegron Domain Metabolism and Endocrinology Reason of inclusion Indication extension IND Main indication Unknown Extended indication Treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 to less than 18 years. Current proprietary name Already available biosimilars / generics Proprietary name Betmiga Manufacturer Astellas Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date December 2021 Expected Registration September 2024 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 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Farmacotherapeutisch kompas Additional remarks Expected cost per patient per year Cost € < 165.00 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 De kosten per 50mg betreffen €0,90 (inclusief BTW). In 2021 bedroegen bij volwassenen de kosten €163,70 per patiënt per jaar. Mogelijk zal dit bij kinderen minder zijn indien een lagere dosering van toepassing is. 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