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

September 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 remarks
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 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

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.