Ticagrelor Medicine 12 June 2018 Extended indication prevention of thrombotic events (cardiovascular death, myocardial infarction or stroke) in patients with coronary artery disease (CAD) and Type 2 Diabetes Mellitus (T2DM) Therapeutic value No judgement yet Total cost Registration phase Clinical trials Product Active substance Ticagrelor Domain Cardiovascular diseases Reason of inclusion Indication extension IND Main indication Other medication for cardiovascular diseases Extended indication prevention of thrombotic events (cardiovascular death, myocardial infarction or stroke) in patients with coronary artery disease (CAD) and Type 2 Diabetes Mellitus (T2DM) Current proprietary name Already available biosimilars / generics Proprietary name Brilique Manufacturer AstraZeneca Portfolio holder Mechanism of action Unknown 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 2019 Expected Registration 2020 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No judgement yet This assessment does not indicate any potential inclusion in the package. Substantiation Therapeutische waarde is afhankelijk van de resultaten van de THEMIS-studie. 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 € < 827.00 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; G-standaard Additional remarks Z-index prijs (€ 1,13 per tablet). Bij de berekening is uitgegaan van 100% therapietrouw. 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 Unknown Indication extensions References Additional remarks Other information Additional remarks