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).

1. 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.

2. 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.

3. 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

4. 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.

5. 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.

6. Potential total cost per year

There is currently nothing known about the possible total cost.

7. Off label use

Off label use
No

8. 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

9. Other information

There is currently no futher information available.