Ticagrelor (1) – Brilique®

Prevention of atherothrombotic events in acute coronary syndrome

Characteristics

Start date 01.01.2011 – Marketing authorisation: 03.12.2010
Resolution 15.12.2011
INN Ticagrelor
Brand name Brilique®
Pharm. company AstraZeneca GmbH
G-BA Procedure ID D-001
ATC code B01AC24 Platelet aggregation inhibitors excl. heparin (B01AC)
DDD 0.18 g O
Therapeutic area Cardiovascular diseases
Reason for procedure Initial assessment

Studies and Results

  • Clinical trials
    • The G-BA reached its decision on whether an additional benefit of ticagrelor compared with the appropriate comparator therapy can be established on the basis of the benefit assessment prepared by the IQWiG and the opinions presented during the written and oral consultation procedures.

a) Unstable angina pectoris (UA)/non-ST-segment elevation myocardial infarction (NSTEMI)

  • There is proof of considerable additional benefit for unstable angina pectoris (IA) and non-ST-segment elevation myocardial infarction (NSTEMI).

b) Myocardial infarction with ST-segment elevation (STEMI), treated with medication: duration of treatment

  • No additional benefit has been proven for the indications STEMI, treated with medication, and STEMI with aortocoronary bypass surgery.

c) Myocardial infarction with ST-segment elevation (STEMI), percutaneous coronary intervention

  • No additional benefit is proven for the indication of STEMI treated with percutaneous coronary intervention, with exceptions both for the group of patients over 75 years of age who, following an individual benefit-risk assessment, are not eligible for treatment with prasugrel + ASA, as well as for patients with a history of transient ischaemic attack or ischaemic stroke.
  • Furthermore, for this indication, an evidence-based but non-quantifiable additional benefit is also identified for patients with a history of transient ischaemic attack or ischaemic stroke.
  • For the indication of STEMI with percutaneous coronary intervention, an evidence-based, non-quantifiable additional benefit is identified for the group of patients aged ≥ 75 years who, following an individual risk-benefit assessment, are not suitable for treatment with prasugrel.

d) Myocardial infarction with ST-segment elevation (STEMI), aortocoronary bypass surgery

  • No additional benefit has been proven for the indications of STEMI treated with medication and STEMI with aortocoronary bypass surgery.

Courtesy translation only, please refer to the German original.

Associated procedures

Ticagrelor (2) Brilique® AstraZeneca GmbH Hematopoietic diseases Prevention of atherothrombotic events in patients with myocardial infarction and high risk for an atherothrombotic event 105,000 100% Hint for minor additional benefit
Ticagrelor (1) Brilique® AstraZeneca GmbH Cardiovascular diseases Prevention of atherothrombotic events in acute coronary syndrome 220,000–269,000 82% Proof of considerable additional benefit


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