Tenapanor Medicine 12 June 2018 Extended indication Irritable bowel syndrome with constipation Therapeutic value No judgement Total cost € 4,587,162.00 Registration phase Clinical trials Product Active substance Tenapanor Domain Chronic immune diseases Reason of inclusion New medicine (specialité) Main indication Bowel diseases Extended indication Irritable bowel syndrome with constipation 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 First-in-class inhibitor of gastrointestinal NHE3 sodium transporter reduces dietary sodium absorption. Scrip pipeline watch 8 en 12 jan 2018: Phase III complete. T3MPO-3 safety extension; effective and well tolerated. 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 Macrogol bij prikkelbare darm syndroom met obstipatie Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 2 times a day Dosage per administration 50 mg References Farmacotherapeutisch kompas; clinicaltrials.gov Additional remarks Expected patient volume per year Patient volume < 79,089 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIPdatabank Additional remarks Aantal patiënten dat Macrogol heeft gekregen in 2016 is 79.089 Expected cost per patient per year Cost € 58.00 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; SPS Additional remarks Geen hoge kosten verwacht in het VK volgens SPS. GIP databank laat zien dat er per gebruiker in 2016 €57,82 vergoed werd aan Macrogol. Potential total cost per year Total cost € 4,587,162.00 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 Hyperphosphatemia References Scrip, clinicaltrials.gov Additional remarks Other information Additional remarks