Patiromer Medicine 09 January 2018 Extended indication Hyperkaliëmie in CHF en CKD in volwassenen. Therapeutic value No judgement Total cost Registration phase Unknown Product Active substance Patiromer Domain Metabolism and Endocrinology Reason of inclusion Main indication Metabolic diseases Extended indication Hyperkaliëmie in CHF en CKD in volwassenen. Current proprietary name Already available biosimilars / generics Proprietary name Veltassa Manufacturer Vifor Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Powder for oral suspension Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Patiromer bindt kalium in het maagdarmkanaal. Risico als blijkt dat meer patienten het gebruiken dan verwacht (naast patienten met nierinsufficientie ook patienten met hartfalen). Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date April 2016 Expected Registration July 2017 Orphan drug No Registration phase Unknown Reimbursement Medicine sluice Additional remarks Geregistreerd in juli 2017, nog niet beschikbaar op de Nederlandse markt. Therapeutic value Current treatment options De behandeling van eerste keus is intraveneuze toediening van calciumgluconaat. Therapeutic value No judgement 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 8,4-16,8-25,2 g References Additional remarks Startdosis is 8,4 g, mag worden opgehoogd tot max. 25,2 g per dag. Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Gering aantal patiënten Expected cost per patient per year Cost € 3,500.00 - 4,500.00 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 Fabrikant Additional remarks Fabrikant (nov 2017): Prijs bij GVS aanvraag €3500 - 4500 pppj. 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