Tenapanor Medicine 12 June 2018 Extended indication Irritable bowel syndrome with constipation Therapeutic value No judgement Total cost € 302,500.00 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 Receptor agonist 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 2020 Expected Registration 2021 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Er is niet één specifieke behandeling die werkt voor alle PDS-patiënten. Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Potentiëel grote markt, geen specifieke behandeling. 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 9,000 - 13,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NHG-Standaard Prikkelbaredarmsyndroom (PDS); Endo et al. Ann Gastroenterol. 2015 Apr-Jun; 28(2): 158–159. Additional remarks De incidentie van prikkelbare darmsyndroom (PDS) in de huisartsenpraktijk is voor de periode 1998 tot 2006 voor mannen 2 tot 3 per 1000 per jaar en voor vrouwen 6 tot 7 per 1000 per jaar (wat neerkomt op ongeveer 76.500 patiënten per jaar). Van alle mensen met klachten die passen bij PDS, zoekt eenderde tot de helft hulp (25.500-38.250). Van de subtypen van PDS beslaat de variant met obstipatie 35% van de gevallen (8.925 - 13.388). Afhankelijk van de effectiviteit en de plaats in de behandelrichtlijn zal een deel van deze patiënten worden behandeld met tenapanor. Expected cost per patient per year Cost € 25.00 - 30.00 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 SPS Additional remarks Geen hoge kosten verwacht in het VK volgens SPS van de NHS. Momenteel word er gemiddeld €25-€30 vergoed per patiënt per jaar aan geneesmiddelen tegen obstipatie. De prijs van tenapanor zal afhangen van de effectiviteit. Potential total cost per year Total cost € 302,500.00 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