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) |
| ICD-10 codes (AIS) | I21.0Type 1 ST elevation myocardial infarction of anterior wall, I21.1Type 1 ST elevation myocardial infarction of inferior wall, I21.2Type 1 ST elevation myocardial infarction of other sites, I21.3Acute transmural myocardial infarction of unspecified site, I21.9Myocardial infarction (acute) NOS, I22.0Subsequent acute transmural myocardial infarction of anterior wall, I22.1Subsequent acute transmural myocardial infarction of inferior wall, I22.8Subsequent acute transmural myocardial infarction of other sites, I22.9Subsequent acute myocardial infarction of unspecified site, I24.9Acute ischemic heart disease, unspecified, I25.20, I25.21, I25.21 |
| Alpha-ID codes (AIS) | I10921Lateral wall infarction of the heart, I111603Anterior wall myocardial infarction, I26801Acute myocardial infarction, I26809Acute transmural myocardial infarction of the posterior wall, I26824Recurrent myocardial infarction of the anterior wall, I26829Recurrent myocardial infarction of the posterior wall, I26839Recurrent myocardial infarction of the lateral wall, I30837Acute coronary syndrome, I4938Acute transmural myocardial infarction, I85542Acute recurrent infarction, I86827Old myocardial infarction, 29 days to less than 4 months ago, I86828Old myocardial infarction, 4 months to less than 1 year ago, I86828Old myocardial infarction, 4 months to less than 1 year ago |
| DDD | 0.18 g O |
| Therapeutic area | Cardiovascular diseases Acute coronary syndrome (ACS), Prevention of atherothrombotic events |
| Reason for procedure | Initial assessment |
| Specialty | Patent/data protection expired |
| Therapeutic indication of the resolution |
|---|
|
Brilique, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndrome (unstable angina, non-ST elevation myocardial infarction [NSTEMI] or ST elevation myocardial infarction [STEMI]), both in patients treated with medication and in patients who have undergone percutaneous coronary intervention (PCI) or aortocoronary artery bypass grafting (CABG). |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Adult patients with unstable angina pectoris (IA) / adult patients with non-ST-segment elevation myocardial infarction (NSTEMI) | Clopidogrel + ASA |
| b) | Adult drug-treated patients with ST-segment elevation myocardial infarction (STEMI) | Clopidogrel + ASA |
| c) | Adult patients with ST-segment elevation myocardial infarction (STEMI) and percutaneous coronary intervention | Prasugrel + ASA |
| d) | Adult patients with ST-segment elevation myocardial infarction (STEMI) and aortocoronary bypass surgery | ASA monotherapy |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (PLATO) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. ACT |
|
Meta analysis
(best subpopulation) |
no |
| Reason for dividing into subpopulations (G-BA) | Patient eligibility, Other |
- 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 | 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 | Prevention of atherothrombotic events in acute coronary syndrome | 220,000–269,000 | 82% Proof of considerable additional benefit |
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