Veverimer Medicine 13 December 2018 Extended indication Metabolic Acidosis Associated With Chronic Kidney Disease Therapeutic value Possible added value Total cost Registration phase Clinical trials Product Active substance Veverimer Domain Metabolism and Endocrinology Reason of inclusion New medicine (specialité) Main indication Metabolic diseases Extended indication Metabolic Acidosis Associated With Chronic Kidney Disease Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Tricida Portfolio holder Mechanism of action Other Route of administration Oral Therapeutical formulation Oral suspension Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Veverimer (TRC101) is a non-absorbed polymer that is designed to bind hydrochloric acid in the GI tract and remove it from the body through excretion in the feces. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2022 Expected Registration 2023 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Bicarbonaat Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Mogelijke meerwaarde verwacht ten opzichte van huidige behandelopties. Duration of treatment Frequency of administration 1 times a day Dosage per administration References NCT03317444 Additional remarks Expected patient volume per year Patient volume > 10,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Nierstichting; Ortega and Arora. Nefrologia. 2012;32(6):724-30 Additional remarks Ruim 10% (1,7 miljoen mensen) van de Nederlandse bevolking heeft chronische nierschade. 40% (680.000 mensen) daarvan weet dat niet. Klachten ontstaan vaak pas als de nierfunctie nog maar 30% is. Hiervan heeft mogelijk 1%-2% metabole acidose. Het gaat hier dus mogelijk om meer dan 10.000 patiënten. Het is momenteel onduidelijk of TRC101 behandeling van deze groep geheel gaat vervangen. 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 No Indication extensions References Additional remarks Other information Additional remarks