Extended indication Patients With Pulmonary Arterial Hypertension
Therapeutic value Possible benefit in ease of use
Total cost 20,294,132.50
Registration phase Clinical trials

Product

Active substance Macitentan / tadalafil
Domain Cardiovascular diseases
Reason of inclusion New medicine (specialité)
Main indication Other medication for cardiovascular diseases
Extended indication Patients With Pulmonary Arterial Hypertension
Manufacturer Actelion
Budgetting framework Extramural (GVS)
Additional comments Endothelin A receptor antagonist

Registration

Registration route Centralised (EMA)
Submission date 2022
Expected Registration 2023
Orphan drug Yes
Registration phase Clinical trials

Therapeutic value

Current treatment options Macitentan en tadalafil worden ook los voorgeschreven.
Therapeutic value Possible benefit in ease of use
Duration of treatment continuous
Frequency of administration 1 times a day
Dosage per administration 10mg en 40mg
References NCT03904693
Additional comments Film-coated tablet with 10mg macitentan and 40mg tadalafil, to be administered orally once daily.

Expected patient volume per year

Patient volume

255 - 884

Market share is generally not included unless otherwise stated.

References ntvg.nl
Additional comments De prevalentie van PAH in Nederland is ongeveer 15-52 per 1.000.000 inwoners.

Expected cost per patient per year

Cost 35,635.00
References CADTH
Additional comments Als separate tabletten onder beoordeling geweest in Canada. De kosten werden in canada geschat op $48.202 pppj, omgerekend naar huidige currency's (juni 2022) komt dit neer op €35.635 pppj

Potential total cost per year

Total cost

20,294,132.50

This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year.

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.