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Dapagliflozine

Forxiga

Extended indication Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)
Therapeutic value No judgement
Total cost 1,611,000.00
Registration phase Clinical trials

Product

Active substance Dapagliflozine
Domain Cardiovascular diseases
Reason of inclusion Indication extension
Main indication Other medication for cardiovascular diseases
Extended indication Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)
Proprietary name Forxiga
Manufacturer AstraZeneca
Route of administration Oral
Therapeutical formulation Film-coated tablet
Budgetting framework Extramural (GVS)
Additional remarks SGLT2-remmer

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date 2019
Expected Registration 2020
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options SGLT2-remmers
Therapeutic value No judgement
Duration of treatment continuous
Frequency of administration 1 times a day
Dosage per administration 5-10 mg
References NCT03036124;NCT03030235

Expected patient volume per year

Patient volume

3,000

Market share is generally not included unless otherwise stated.
References GIP databank 2017
Additional remarks 2.754 gebruikers van Entresto in 2017, inschatting: zo'n 3.000 gebruikers per jaar.

Expected cost per patient per year

Cost 537.00
References Z-index
Additional remarks Uitgaande van 100% therapietrouw en tabletten van 10 mg en de Z-index prijs (€1,47 per tablet), zijn de kosten €537,00 p.p.p.j.. Komt bovenop de kosten voor Entresto.

Potential total cost per year

Total cost

1,611,000.00

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

Off label use No

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.