Dapagliflozine

Active substance
Dapagliflozine
Domain
Cardiovascular diseases
Reason of inclusion in Horizonscan Geneesmiddelen
Indication extension
Main indication
Other medication for cardiovascular diseases
Extended indication
Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)

1. Product

Proprietary name
Forxiga
Manufacturer
AstraZeneca
Mechanism of action
SGLT inhibitor
Route of administration
Oral
Therapeutical formulation
Film-coated tablet
Budgetting framework
Extramural (GVS)

2. Registration

Registration route
Centralised (EMA)
Type of trajectory
Normal trajectory
Submission date
2020
Expected Registration
2021
Orphan drug
No
Registration phase
Clinical trials
Additional comments
De fabrikant geeft aan dat de verwachte registratie in 2021 zal plaatsvinden.

3. Therapeutic value

Current treatment options
SGLT2-remmers
Therapeutic value
Potential added value
Substantiation
Het wordt steeds duidelijker dat deze compounds CV events voorkomen bij diabeten met gekend atherosclerotisch vaatlijden en de rol van deze compounds bij HF is nu focus van veel onderzoek. De verwachting is dat SGLT2-remmers een grote impact gaan hebben bij HFrEF.
Frequency of administration
1 times a day
Dosage per administration
5-10 mg
References
NCT03036124;NCT03030235

4. Expected patient volume per year

Patient volume

3,000

Market share is generally not included unless otherwise stated.

References
GIP databank 2017
Additional comments
2.754 gebruikers van Entresto in 2017, inschatting: zo'n 3.000 gebruikers per jaar die in aanmerking kunnen komen voor Dapagliflozine.

5. Expected cost per patient per year

Cost
537
References
Z-index
Additional comments
Uitgaande van 100% therapietrouw en tabletten van 10 mg en de Z-index prijs (€1,47 per tablet), zijn de kosten €537 per patiënt per jaar.

6. Potential total cost per year

Total cost

1,611,000

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.

7. Off label use

Off label use
No

8. Indication extension

There is currently nothing known about indication extensions.

9. Other information

There is currently no futher information available.