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

Since the start of 2011, the active ingredient ticagrelor can be prescribed in Germany in addition to acetylsalicylic acid (ASA) to avoid blood clots in patients with acute ischaemia of the cardiac muscle. The German Institute for Quality and Efficiency in Health Care (IQWiG) has now examined whether ticagrelor offers advantages to patients with acute coronary syndrome (ACS) in comparison with conventional drugs. This is the first co-called "early benefit assessment" that IQWiG has performed on the basis of a dossier provided by the manufacturer, in accordance with the new legal regulations.

The Institute has come to the conclusion that ticagrelor provides considerable added benefit to patients with "mild" myocardial infarction without the typical changes in the ECG (NSTEMI), as well as to patients with unstable angina pectoris, by reducing the risk of death and myocardial infarction. However, there is no corresponding proof for "severe" myocardial infarction (STEMI), in which there are usually characteristic changes in the ECG.

IQWiG assesses, G-BA decides

The company AstraZeneca developed the drug and introduced it to the German market at the start of 2011, under the trade name of Brillique. On 1 January 2011, the German Act on the Reform of the Market for Medicinal Products (AMNOG) came into force, which lays down that new pharmaceuticals should regularly be subjected to a benefit assessment. For this purpose, the pharmaceutical company must submit a dossier containing proof of the added benefit, in comparison to the "appropriate comparator". The latter is specified by the Federal Joint Committee (G-BA).

The G-BA is responsible for the overall process, but can commission IQWiG to assess the manufacturer's dossier - as happened with ticagrelor. IQWiG then issues a recommendation as to how the added benefit is to be classified. After the commenting procedure, the G-BA reaches a formal decision on this added benefit.
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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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