Tenapanor Medicine 12 June 2018 Extended indication Hyperphosphatemia Therapeutic value No judgement Total cost € 39,045,600.00 Registration phase Clinical trials Product Active substance Tenapanor Domain Metabolism and Endocrinology Reason of inclusion Indication extension IND Main indication Hormonal disorders Extended indication Hyperphosphatemia Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Ardelyx Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Scrip pipeline watch 13 nov 2017: decreased potassium, well tolerated. "First-in-class inhibitor of gastrointestinal NHE3 sodium transporter reduces dietary sodium absorption". Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2019 Expected Registration 2020 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Fosfaatbinders zoals sevelameer, ferrioxidesaccharaat, lanthaancarbonaat, calciumacetaat/magnesiumcarbonaat Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References Farmacotherapeutisch kompas. Additional remarks Expected patient volume per year Patient volume < 11,832 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIPdatabank Additional remarks Aantal patiënten dat fosfaatbinders heeft gekregen in 2016 betreft 11.832. Expected cost per patient per year Cost € 3,300.00 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 GIPdatabank Additional remarks Vergoeding per gebruiker voor fosfaatbinders in 2016 betreft €3.292,39 Potential total cost per year Total cost € 39,045,600.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Ook in PhIII voor de indicatie: "Constipation Predominant Irritable Bowel Syndrome". References Scrip, clinicaltrials.gov. Additional remarks Other information Additional remarks