Extended indication Treatment of patients with chronic kidney disease.
Therapeutic value Possible added value
Total cost 10,091,500.00
Registration phase Clinical trials

Product

Active substance Empagliflozine
Domain Metabolism and Endocrinology
Reason of inclusion Indication extension
Main indication Other metabolism and Endocrinology
Extended indication Treatment of patients with chronic kidney disease.
Proprietary name Jardiance
Manufacturer Boehringer Ingelheim
Mechanism of action SGLT inhibitor
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date January 2023
Expected Registration December 2023
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Therapeutic value Possible added value
Substantiation SGLT2-remmers (empagliflozine en dapagliflozine): laten overtuigend gunstige effecten zien bij mensen met hartfalen en chronisch nierfalen die onafhankelijk zijn van het glucose verlagend effect, deze twee geneesmiddelen zullen vaak ingezet gaan worden bij die aandoeningen, zowel met als zonder diabetes, inmiddels staan ze ook al prominent in de richtlijnen.
Duration of treatment continuous
Frequency of administration 1 times a day
Dosage per administration 10mg
References NCT03594110

Expected patient volume per year

Patient volume

< 20,183

Market share is generally not included unless otherwise stated.

References Nieratlas
Additional comments De patiënt met chronische nierschade heeft een ernstig verminderde nierfunctie die niet behandeld wordt met dialyse of een niertransplantatie. Deze patiënten hebben een diagnosebehandelcode (DBC) nummer 325

Expected cost per patient per year

Cost < 500.00
References G-standaard
Additional comments €38,40 per 28 stuks

Potential total cost per year

Total cost

10,091,500.00

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.