Macitentan / tadalafil Medicine 07 December 2021 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 € 20,311,950.00 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. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Janssen Portfolio holder Janssen Mechanism of action Unknown Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Endothelin A receptor antagonist Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date June 2023 Expected Registration September 2024 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Macitentan en tadalafil worden ook los voorgeschreven. Therapeutic value Possible benefit in ease of use This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment 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. Maximum patient volume for sluice 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 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. 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 € 20,311,950.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks