Extended indication Extension of indication to include paediatric use (from 6 months to 17 years) for pulmonary arterial
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Tadalafil
Domain Cardiovascular diseases
Reason of inclusion Indication extension
Main indication Other medication for cardiovascular diseases
Extended indication Extension of indication to include paediatric use (from 6 months to 17 years) for pulmonary arterial hypertension (PAH) (from 6 months to 17 years).
Proprietary name Adcirca
Manufacturer Eli Lilly
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 January 2022
Expected Registration February 2023
Orphan drug No
Registration phase Registration application pending
Additional comments De fabrikant verwacht registratie in 2023.

Therapeutic value

Current treatment options Sildenafil
Therapeutic value No estimate possible yet
Substantiation Er wordt verwacht dat tadalafil de concurrentie aan zal moeten gaan met sildenafil. Er worden vergelijkbare resultaten verwacht als bij volwassenen daarnaast is het geneesmiddel veilig bevonden.

Expected patient volume per year

Patient volume

< 130

Market share is generally not included unless otherwise stated.

References GIP databank
Additional comments Het is nog de vraag of er een markt zal zijn voor dit geneesmiddel in deze leeftijdsgroep. Het maximale aantal patiënten is de groep die nu sildenafil krijgt. 116 patiënten van 0 tot en met 14 jaar ontvangen op dit moment sildenafil en 147 patiënten van 0 tot en met 24 jaar ontvangen sildenafil. Inschatting voor Tadalafil is maximaal 130 patiënten.

Expected cost per patient per year

References Medicijnkosten.nl
Additional comments Adcirca tablet filmomhuld 20mg: €10,37 per stuk,.

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.