Ticagrelor

Active substance Ticagrelor
Domain Cardiovascular diseases
Reason of inclusion in Horizonscan Geneesmiddelen Indication extension
Main indication Other medication for cardiovascular diseases
Extended indication Extension of indication to include, in co administration with acetylsalicylic acid (ASA), the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD)and type 2 diabetes mellitus (T2DM) without a history of myocardial infarction who have undergone percutaneous coronary intervention (PCI).

Product

Proprietary name Brilique
Manufacturer AstraZeneca
Mechanism of action Receptor antagonist
Route of administration Oral
Therapeutical formulation Film-coated tablet
Budgetting framework Extramural (GVS)
Additional comments P2Y12-receptorantagonist.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date August 2019
Expected Registration November 2020
Orphan drug No
Registration phase Registration application pending
Additional comments Fabrikant geeft aan registratie in Q4 2020 te verwachten.

Therapeutic value

Current treatment options clopidogrel/​acetylsalicylzuur
Therapeutic value No judgement yet
Substantiation De THEMIS studie heeft de primaire eindpunten gehaald. Absolute risicoreductie is niet heel groot en 2 maal daagse dosering blijft lastig in verband met therapietrouw. De inschatting is echter dat de inzet van ticagrelor in de tweede lijn bij diabetes type 2 patiënten beperkt zal zijn vanwege alternatieve behandelopties.
Frequency of administration 2 times a day
Dosage per administration 60 mg
References NCT01991795; Fabrikant

Expected patient volume per year

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

Expected cost per patient per year

Cost 834
References G-standaard
Additional comments Brilique kost €1,142 per tablet van 60/90 mg. Bij gebruik van een jaar komt dit neer op €834.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

Off label use No

Indication extension

Indication extension Yes
Indication extensions Acute ischaemic stroke or transient ischaemic attack; prevention of vaso-occlusive crises in paediatric patients with sickle cell disease
References Pipeline AstraZeneca

Other information

There is currently no futher information available.