Extended indication Prevention of cardiovascular events in Type 2 diabetes mellitus patients with coronary artery disease.
Therapeutic value No judgement yet
Registration phase Clinical trials

Product

Active substance Ticagrelor
Domain Cardiovascular diseases
Main indication Other medication for cardiovascular diseases
Extended indication Prevention of cardiovascular events in Type 2 diabetes mellitus patients with coronary artery disease.
Proprietary name Brilique
Manufacturer AstraZeneca
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)
Additional remarks P2Y12-receptorantagonist.

Registration

Registration route Centralised (EMA)
Particularity Indication extension
Submission date 2019
Expected Registration 2019
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Therapeutic value No judgement yet
Substantiation Therapeutische waarde is afhankelijk van de resultaten van de THEMIS-studie. De inschatting van de werkgroep is echter dat de inzet van ticagrelor in de tweede lijn bij diabetes type 2 patiƫnten beperkt zal zijn vanwege alternatieve behandelopties.
Duration of treatment continuous
Frequency of administration 2 times a day
Dosage per administration 60 mg
References NCT01991795; Fabrikant

Expected patient volume per year

References De inschatting van de werkgroep is dat de inzet van ticagrelor bij deze indicatie beperkt zal zijn en er dus geen groot patiƫntvolume te verwachten is.

Expected cost per patient per year

Cost < 831.00
References Fabrikant; G-standaard
Additional remarks Huidige prijs brilique 60mg (1,139 Eur per eenheid).

Potential total cost per year

There is currently nothing known about the possible total cost.

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.