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Ambrisentan

Volibris

Extended indication

Extension application to introduce a new strength (2.5 mg film-coated tablet), grouped with an exten

Therapeutic value

No estimate possible yet
Registration phase

Registered

Product

Active substance

Ambrisentan
Domain

Lung diseases
Reason of inclusion

Indication extension
Main indication

Lung diseases other
Extended indication

Extension application to introduce a new strength (2.5 mg film-coated tablet), grouped with an extension of indication to include treatment of PAH in adolescents and children (8 to less than 18 years).
Proprietary name

Volibris
Manufacturer

GSK
Mechanism of action

Receptor antagonist
Route of administration

Oral
Therapeutical formulation

Tablet
Budgetting framework

Extramural (GVS)

Registration

Registration route

Centralised (EMA)
Type of trajectory

Normal trajectory
ATMP

No
Submission date

2021
Expected Registration

September 2021
Orphan drug

Yes
Registration phase

Registered
Additional comments 
Positieve CHMP opinie juli 2021.

Therapeutic value

Therapeutic value

No estimate possible yet
Substantiation

betreft een indicatie-uitbreiding naar kinderen en adolescenten.

Expected patient volume per year

References 
ntvg.nl
Additional comments 
De prevalentie van PAH in Nederland is ongeveer 15-52 per 1 miljoen inwoners. Gezien het een pediatrische uitbreiding betreft zal slecht een klein deel ven de patiënten in aanmerking komen.

Expected cost per patient per year

References 
medicijnkosten.nl, GIP databank
Additional comments 
Prijs per tablet van 5mg per stuk  €52,32 exclusief afleverkosten en inclusief BTW. Prijs per tablet van 10mg per stuk €83,70 exclusief afleverkosten en inclusief BTW. De vergoeding per gebruiker in 2020 betrof €22.243.

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

Indication extension

No
References 
Adis Insight

Other information

There is currently no futher information available.