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Dapagliflozine

Forxiga

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 37,000.00
Registration phase Positive CHMP opinion

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 December 2021
Orphan drug No
Registration phase Positive CHMP opinion
Additional remarks Fabrikant verwacht registratie in het vierde kwartaal van 2021. Positieve CHMP opinie ontvangen oktober 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 remarks 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 370.00
References medicijnkosten;
Additional remarks Forxiga tablet filmomhuld 5mg 1x per dag dus 365,25*€1,014= €370,36

Potential total cost per year

Total cost

37,000.00

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

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Renal failure
References adisinsight
Additional remarks Lopende fase 3 studie

Other information

There is currently no futher information available.