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Tenapanor

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
Main indication Bowel diseases
Extended indication Irritable bowel syndrome with constipation
Manufacturer Ardelyx
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)
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. Fabrikant: Ardelyx

Registration

Registration route Centralised (EMA)
Particularity New medicine
Submission date 2018
Expected Registration 2019
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options Macrogol bij prikkelbare darm syndroom met obstipatie
Therapeutic value No judgement
Frequency of administration 2 times a day
Dosage per administration 50 mg
References Farmacotherapeutisch kompas; clinicaltrials.gov

Expected patient volume per year

Patient volume

< 79,089

Market share is generally not included unless otherwise stated.
References GIPdatabank
Additional remarks Aantal patiënten dat Macrogol heeft gekregen in 2016 is 79.089

Expected cost per patient per year

Cost 58.00
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

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.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Hyperphosphatemia
References Scrip, clinicaltrials.gov

Other information

There is currently no futher information available.