Macitentan / tadalafil Medicine 07 December 2021 Extended indication Patients With Pulmonary Arterial Hypertension Therapeutic value Possible benefit in ease of use Total cost 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 Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Actelion Portfolio holder 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 Unknown Submission date 2022 Expected Registration 2023 Orphan drug Yes Registration phase Clinical trials 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 References Additional remarks Potential total cost per year Total cost 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