Riociguat Medicine 07 December 2022 Extended indication Extension of indication to include treatment of pulmonary arterial hypertension (PAH) in paediatric patients aged 6 to less than 18 years of age with WHO Functional Class (FC) I to III in combination with endothelin receptor antagonists with or without prostanoids for ADEMPAS Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Riociguat Domain Lung diseases Reason of inclusion Indication extension IND Main indication Lung diseases other Extended indication Extension of indication to include treatment of pulmonary arterial hypertension (PAH) in paediatric patients aged 6 to less than 18 years of age with WHO Functional Class (FC) I to III in combination with endothelin receptor antagonists with or without prostanoids for ADEMPAS Current proprietary name Already available biosimilars / generics Proprietary name Adempas Manufacturer Bayer Portfolio holder Bayer Mechanism of action Vasodilator Route of administration Oral Therapeutical formulation Coated tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date September 2022 Expected Registration July 2023 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet 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 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 farmacotherapeutisch kompas Additional remarks Adempas, tablet 2 mg: € 70,05 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