Patiromer Medicine 09 January 2018 Extended indication Hyperkaliëmie in CHF en CKD in volwassenen. Therapeutic value No judgement Total cost Registration phase Registered Product Active substance Patiromer Domain Metabolism and Endocrinology Reason of inclusion New medicine (specialité) 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. 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 Registered Reimbursement Medicine sluice Additional remarks Geregistreerd in juli 2017. Vergoedingsdossier wordt beoordeeld. 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 - 4,000.00 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 (april 2018): €3500 - 4000 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 Risico als blijkt dat meer patienten het gebruiken dan verwacht (naast patienten met nierinsufficientie ook patienten met hartfalen) Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks