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

patients with STEMI. In patients whose coronary arteries had been expanded with a balloon catheter (PCI) after a STEMI, the comparison with prasugrel (another coagulation inhibitor) showed no advantages for ticagrelor. No informative data were provided by the manufacturer for patients who had only been given drug treatment after a STEMI or who had received a bypass operation. One reason for this was that AstraZeneca deviated from the appropriate comparator which the G-BA specified for the therapeutic indication "STEMI". In the opinion of IQWiG, AstraZeneca has not adequately justified this deviation, given that it was even partially inconsistent with the approval status of the coagulation inhibitors.

The law demands that benefits and harms should be balanced

According to the Institute's Director, Jrgen Windeler, "Myocardial infarctions and deaths are rarer with ticagrelor than with clopidogrel. However, there is also proof of more harm, such as increased dyspnoea. It is difficult to balance these advantages and disadvantages. Value judgements play a role here and to date there is no generally accepted scientific method for striking such a balance."

Nevertheless, IQWiG has to do this, as the legislator explicitly demands that a benefit assessment according to AMNOG should contain an overall conclusion, including a conclusion on the extent of the added benefit. According to Windeler, IQWiG has explained how they have arrived at the assessment of the different outcomes and how they have come to the overall conclusion. They explicitly wish this to be viewed as a suggestion. Not only the results, but also the methods could be discussed during the commenting procedure at the G-BA. They hope and wish that the procedure IQWiG has used in the case of ticagrelor will encourage scientific debate.

Patients and external experts involved

Both patients and external experts are regularly involved in the assessment of
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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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