Extended indication Hyperphosphatemia
Therapeutic value No estimate possible yet
Total cost 39,045,600.00
Registration phase Clinical trials

Product

Active substance Tenapanor
Domain Metabolism and Endocrinology
Reason of inclusion Indication extension
Main indication Hormonal disorders
Extended indication Hyperphosphatemia
Manufacturer Ardelyx
Mechanism of action Other
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)
Additional comments 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)
Submission date 2021
Expected Registration 2022
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options Fosfaatbinders zoals sevelameer, ferrioxidesaccharaat, lanthaancarbonaat, calciumacetaat/​magnesiumcarbonaat.
Therapeutic value No estimate possible yet
References Farmacotherapeutisch kompas.

Expected patient volume per year

Patient volume

< 11,832

Market share is generally not included unless otherwise stated.

References GIPdatabank
Additional comments Aantal patiënten dat fosfaatbinders heeft gekregen in 2016 betreft 11.832.

Expected cost per patient per year

Cost 3,300.00
References GIPdatabank
Additional comments Vergoeding per gebruiker voor fosfaatbinders in 2016 betreft €3.292,39.

Potential total cost per year

Total cost

39,045,600.00

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 Ook in Phase 3 voor de indicatie: "Constipation Predominant Irritable Bowel Syndrome".
References Scrip, clinicaltrials.gov.

Other information

There is currently no futher information available.