Ambrisentan Medicine 13 December 2018 Extended indication Behandeling van pulmonale arteriële hypertensie (PAH) bij volwassen patiënten geclassificeerd als WHO functionele klasse (FC) II of III, waaronder gebruik in een combinatietherapie. Therapeutic value Possible equal value Total cost Registration phase Registered and reimbursed Product Active substance Ambrisentan Domain Lung diseases Reason of inclusion Generic G Main indication Lung other Extended indication Behandeling van pulmonale arteriële hypertensie (PAH) bij volwassen patiënten geclassificeerd als WHO functionele klasse (FC) II of III, waaronder gebruik in een combinatietherapie. Current proprietary name Volibris (GSK) Already available biosimilars / generics Proprietary name Ambrisentan Mylan Manufacturer Mylan Portfolio holder Mechanism of action Receptor antagonist Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Unknown Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date June 2018 Expected Registration June 2019 Orphan drug Yes Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks SPC Volibris verloopt op 6 oktober 2020. Positieve CHMP-opinie april 2019. Geregistreerd in juni 2019. Therapeutic value Current treatment options Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks 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