Ticagrelor Medicine 12 June 2018 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). Therapeutic value No estimate possible yet Total cost Registration phase No registration expected Product Active substance Ticagrelor Domain Cardiovascular diseases Reason of inclusion Indication extension IND 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). Current proprietary name Already available biosimilars / generics Proprietary name Brilique Manufacturer AstraZeneca Portfolio holder Mechanism of action Receptor antagonist Route of administration Oral Therapeutical formulation Film-coated tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks P2Y12-receptorantagonist. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date August 2019 Expected Registration May 2021 Orphan drug No Registration phase No registration expected Reimbursement Medicine sluice Additional remarks Registratieaanvraag teruggetrokken in mei 2021. Therapeutic value Current treatment options clopidogrel/acetylsalicylzuur Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. 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 Frequency of administration 2 times a day Dosage per administration 60 mg References NCT01991795; Fabrikant Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References De inschatting is dat de inzet van ticagrelor bij deze indicatie beperkt zal zijn en er dus geen groot patiëntvolume te verwachten is. Additional remarks Expected cost per patient per year Cost € 770.00 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. References fabrikant; Z-index Additional remarks 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 Total cost Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions 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 Additional remarks Other information Additional remarks