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Ticagrelor: Considerable added benefit for specific patients
Date:10/11/2011

The assessment is only then complete.

Advantages in mortality and myocardial infarction

The G-BA specified clopidogrel as the appropriate comparator for the therapeutic indication of unstable angina pectoris or NSTEMI. On the basis of data from the PLATO study, the manufacturer could demonstrate that ticagrelor offers advantages to patients for this therapeutic indication. There were fewer deaths with ticagrelor than with clopidogrel. There were also fewer myocardial infarctions with ticagrelor, although it was not clear to what extent these were relevant to the analysis, i.e. were perceptible, myocardial infarctions.

No proof that severe bleeding events are more frequent

Drugs that inhibit parts of the blood clotting system generally also increase the risk of bleeding. However, severe bleeding events were no more frequent during treatment with ticagrelor than during treatment with clopidogrel. On the other hand, there was proof of more harm from ticagrelor with respect to study discontinuations due to adverse events and shortage of breath (dyspnoea).

Added benefit of intermediate category in patients with unstable angina pectoris and NSTEMI

After considering the individual results, IQWiG has classified the added benefit of ticagrelor in comparison with clopidogrel as being "considerable" in patients with unstable angina pectoris or NSTEMI. The legislator has classified three different degrees of added benefit - "minor", "considerable" and "major" in order to determine its extent. However, according to the legal requirements, the highest category should be reserved for drugs which give "persistent great improvement, which has not previously been seen". In other words, it must be regarded as a breakthrough in the treatment of the disease.

No proof of added benefit for patients with STEMI

The dossier failed to provide proof that ticagrelor is of added benefit for
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Contact: Anna-Sabine Ernst
presse@iqwig.de
49-221-356-850
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

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