Extended indication

Extension of indication for Forxiga / Edistride to include treatment of children aged 10 years and a

Therapeutic value

No estimate possible yet

Total cost

53,700.00

Registration phase

Registration application pending

Product

Active substance

Dapagliflozine

Domain

Metabolism and Endocrinology

Reason of inclusion

Indication extension

Main indication

Diabetes

Extended indication

Extension of indication for Forxiga / Edistride to include treatment of children aged 10 years and adolescents with T2DM based on the results from studies

Proprietary name

Forxiga

Manufacturer

AstraZeneca

Mechanism of action

SGLT inhibitor

Route of administration

Oral

Therapeutical formulation

Film-coated tablet

Budgetting framework

Extramural (GVS)

Registration

Registration route

Centralised (EMA)

Type of trajectory

Normal trajectory

Submission date

December 2020

Expected Registration

September 2021

Orphan drug

No

Registration phase

Registration application pending

Additional comments
Fabrikant verwacht registratie in het tweede/derde kwartaal van 2021.

Therapeutic value

Therapeutic value

No estimate possible yet

Substantiation

Op dit moment zijn er niet veel patiënten in Nederland in deze leeftijdsgroep die in aanmerking zullen komen voor dapagliflozine.

Duration of treatment

continuous

Frequency of administration

1 times a day

Dosage per administration

5mg

References
NCT03199053

Expected patient volume per year

Patient volume

< 100

Market share is generally not included unless otherwise stated.

References
Baan CA, Poos MJJC. Hoe vaak komt diabetes mellitus voor en hoeveel mensen sterven eraan? In: Volksgezondheid Toekomst Verkenning, Nationaal Kompas Volksgezondheid. Bilthoven: RIVM, 2013.; Diabetes vereniging Nederland;
Additional comments
Het overgrote deel (ongeveer 98%) van de kinderen heeft DM type 1. Het aantal kinderen met DM type 2 is de laatste jaren toegenomen. Ongeveer 12.000 kinderen en jongvolwassenen hebben diabetes. Dit betekent dat er maximaal 240 patiënten in Nederland DM type 2 hebben. Naar verwachting zal deze behandeling bij maximaal 100 patiënten ingezet worden.

Expected cost per patient per year

Cost

537.00

References
medicijnkosten;
Additional comments
Forxiga tablet filmomhuld 5mg 1x per dag dus 365,25*€1,47= €537

Potential total cost per year

Total cost

53,700.00

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

Renal failure

References
adisinsight
Additional comments
Lopende fase 3 studie

Other information

There is currently no futher information available.