Extended indication Extension of indication to include, in co administration with acetylsalicylic acid (ASA), the preven
Therapeutic value No estimate possible yet
Registration phase No registration expected

Product

Active substance Ticagrelor
Domain Cardiovascular diseases
Reason of inclusion 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).
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 May 2021
Orphan drug No
Registration phase No registration expected
Additional comments Registratieaanvraag teruggetrokken in mei 2021.

Therapeutic value

Current treatment options clopidogrel/​acetylsalicylzuur
Therapeutic value No estimate possible 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.
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 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 770.00
References fabrikant; Z-index
Additional comments De prijs van Brilique 90mg (op basis van 56-stuks verpakking) is inmiddels gedaald naar €1,06. Bij gebruik van een jaar komt dit neer op 2x€1,055x365 = €770,28.

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.