Macitentan / tadalafil

Extended indication	Long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III.
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 van PAH in Nederland is ongeveer 15-52 per 1.000.000 inwoners.

Patient volume

255 - 884

Market share is generally not included unless otherwise stated.

References

ntvg.nl

Additional remarks

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 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.

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.

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.