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.