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Macitentan / tadalafil

Yuvanci

Extended indication Yuvanci is indicated as substitution therapy for the long-term treatment of pulmonary arterial hyper
Therapeutic value Possible benefit in ease of use
Total cost 20,294,132.50
Registration phase Registered and reimbursed

Product

Active substance Macitentan / tadalafil
Domain Cardiovascular diseases
Reason of inclusion New medicine (specialité)
Main indication Other medication for cardiovascular diseases
Extended indication Yuvanci is indicated as substitution therapy for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, who are already treated with the combination of macitentan and tadalafil given concurrently as separate tablets.
Proprietary name Yuvanci
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 Registered and reimbursed
Additional remarks Positieve CHMP opinie juli 2024

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.