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Macitentan / tadalafil

Extended indication

Long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Cla

Therapeutic value

Possible benefit in ease of use
Total cost

20,294,132.50
Registration phase

Registration application pending

Product

Active substance

Macitentan / tadalafil
Domain

Cardiovascular diseases
Reason of inclusion

New medicine (specialité)
Main indication

Other medication for cardiovascular diseases
Extended indication

Long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III.
Manufacturer

Janssen
Portfolio holder

Janssen
Budgetting framework

Extramural (GVS)
Additional remarks 
Endothelin A receptor antagonist

Registration

Registration route

Centralised (EMA)
ATMP

No
Submission date

June 2023
Expected Registration

September 2024
Orphan drug

Yes
Registration phase

Registration application pending

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 remarks 
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 remarks 
De prevalentie in Nederland is ongeveer 15 tot 52 patiënten per 1.000.000 inwoners.

Expected cost per patient per year

Cost

35,635.00
References 
CADTH
Additional remarks 
Als separate tabletten onder beoordeling geweest in Canada. De kosten werden in Canada geschat op $48,202 per patiënt per jaar, omgerekend naar huidige valuta (juni 2022) komt dit neer op €35.635 per patiënt per jaar.

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.