Pharmaceutical company defends itself against IQWiG reports

Recommended use only for subgroups of acute coronary syndrome

The so-called platelet aggregation inhibitor Brilique (ticagrelor) from the British pharmaceutical company AstraZeneca has been on the market since January 2011. However, the German Institute for Quality and Efficiency in Health Care (IQWiG) and the Federal Joint Committee (G-BA) clearly restricted the application recommendation of the drug, which was originally developed for the treatment of all patients with acute coronary syndrome, in a first evaluation.

On the basis of numerous submitted dossiers, IQWiG had examined the usefulness of the novel preparation in the treatment of patients with acute coronary syndrome and found that Brilique (ticagrelor) has a "considerable additional benefit" compared to previous medicines. With a three-level scale of "low", "considerable" and "substantial", this translates to a medium additional benefit. However, the institute believes that the added benefit does not apply to all forms of acute coronary syndrome. The British pharmaceutical company is now massively defending itself against this restriction and has raised the accusation that the result can only be attributed to the G-BA's choice of comparative therapy. In front of the Federal Joint Committee, which, as the highest decision-making body for the self-administration of doctors, dentists, psychotherapists, hospitals and health insurance companies, also determines which treatment methods are covered by the insurance companies, the group now wants to work "to ensure that the mortality advantage demonstrated in all patient groups becomes apparent the evaluation will be reflected, "said Dr. Claus Runge, from the AstraZeneca management.

One of the requirements of the Medicinal Products Reorganization Act (AMNOG) provides that all medications, the use of which is to be covered by the statutory health insurance companies, must first demonstrate their additional benefits in a test procedure. This also applies to the novel platelet aggregation inhibitor from AstraZeneca, which was intended in combination with acetylsalicylic acid (ASA) for the treatment of all patients with acute coronary syndrome. only in heart attack patients without so-called ST segment elevations and in patients with unstable angina pectoris (circulatory disorder of the heart). According to the manufacturer, this affects around 75 percent of all patients with acute coronary syndrome, but AstraZeneca had hoped for a broader field of application. The pharmaceutical company was unable to follow the IQWiG's statement that the data submitted on the effect on patients with ST segment elevation infarction (STEMI) were not sufficient for a positive assessment.

The critical assessment of the IQWiG can only be traced back to the selection of the comparative therapies by the G-BA, the accusation of the pharmaceutical company. The assessment that Brilique (ticagrelor) brings an additional benefit to patients with ST segment elevation infarction "is controversial and largely due to the choice of comparative therapy in this subgroup by the G-BA", AstraZeneca complained. The G-BA chose here - not like the first indication group clopidogrel plus ASA - but, for example, the preparation prasugrel as a comparative therapy. The pharmaceutical company now said that the IQWiG's report would be thoroughly examined internally in order to uncover possible weaknesses. AstraZeneca also refers to the European Medicines Agency (EMA), which Brilique had certified as an additional benefit in all indication groups of acute coronary syndrome. However, the preparation was only compared with clopidogrel plus ASA, other existing therapy options were not taken into account. The same applies to England, Wales, Denmark and Scotland, where the test centers Brilique (Ticagrelor) also confirmed a clear additional benefit.

The fact that the recommendation for use does not apply to all patient groups of acute coronary syndrome only in Germany is cause for massive criticism for the pharmaceutical company. Other pharmaceutical manufacturers had also criticized the choice of comparative therapies in previous approval procedures and blamed them for the fact that no additional benefit was found for their preparations. However, the G-BA's approach at this point seems perfectly understandable, because the new active ingredients should always be compared with the most efficient treatment method to date, and this can be quite different in the various forms of acute coronary syndrome. (fp)

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