Extended indication Treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 to less than 18 years.
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Mirabegron
Domain Metabolism and Endocrinology
Reason of inclusion Indication extension
Extended indication Treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 to less than 18 years.
Proprietary name Betmiga
Manufacturer Astellas
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date December 2021
Expected Registration February 2023
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet

Expected patient volume per year

References Farmacotherapeutisch kompas
Additional comments Kosten van een tablet Betmiga 50mg zijn €0,90. Kosten per patiënt per jaar zullen afhankelijk zijn van behandelduur, toedieningsfrequentie en hoeveelheid.

Expected cost per patient per year

Cost < 165.00
References medicijnkosten.nl; GIP-databank
Additional comments De kosten per 50mg betreffen 0,90 eurocent (incl. BTW). Bij volwassenen bedroegen de kosten per patient per jaar in 2021 163,70 euro. Mogelijk zal dit bij kinderen minder zijn indien een lagere dosering van toepassing is.

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.