Pharmaceutical company defends itself against IQWiG report

Recommendation only for subgroups of the acute coronary syndrome

05/10/2011

Since January 2011, the so-called antiplatelet drug Brilique (ticagrelor) of the British pharmaceutical company AstraZeneca on the market. The recommendation for use of the drug originally developed for the treatment of all patients with acute coronary syndrome, however, was clearly limited in a first assessment by the German Institute for Quality and Efficiency in Health Care (IQWiG) and the Joint Federal Committee (G-BA).

Based on numerous submitted dossiers, the IQWiG had reviewed the benefit of the novel preparation in the treatment of patients with acute coronary syndrome and found that Brilique (ticagrelor) a „considerable added value“ compared to previous drugs. On a three-level scale of „low“, „considerably“ and „substantially“ this translates to a mean added benefit. However, according to the institute, the added benefit does not apply to all forms of acute coronary syndrome. The British pharmaceutical company is now vigorously resisting this restriction, accusing it of attributing the result to the selection of the G-BA comparator therapy. In front of the Joint Federal Committee, which, as the supreme decision-making body of self-administration of doctors, dentists, psychotherapists, hospitals and health insurance companies, also determines which treatment methods are to be borne by the health insurance funds, the Group now wants to work for them, „that the mortality advantage demonstrated in all patient groups will be reflected in the assessment“, explained Dr. Claus Runge, from the AstraZeneca management.

One of the requirements of the German Medicines Reorganization Act (AMNOG) stipulates that all drugs whose use is to be taken over by the statutory health insurance companies must prove their additional benefit in a test procedure beforehand. This also applies to the novel antiplatelet drug AstraZeneca, which was intended in combination with acetylsalicylic acid (ASA) for the treatment of all patients with acute coronary syndrome. However, the IQWiG comes in his study to the conclusion that the added benefit of Brilique plus acetylsalicylic acid (ASA) only in myocardial infarction patients without so-called ST segment elevations and in patients with unstable angina pectoris (circulatory disorder of the heart). Although this affects about 75 percent of all patients with acute coronary syndrome, according to the manufacturer, AstraZeneca had hoped for a broader field of application. The IQWiG's statement that the presented data on the effect in patients with ST segment raising infarcts (STEMI) are not sufficient for a positive evaluation, the pharmaceutical company could not follow.

The critical assessment of the IQWiG merely goes back to the selection of comparative therapies by the G-BA, according to the allegation of the pharmaceutical company. The assessment that Brilique (ticagrelor) brings an added benefit to patients with ST-range uptake infarcts, „is controversial and significantly attributable to the choice of comparator therapy in this subgroup by the G-BA“, criticized AstraZeneca. Because the G-BA chose here - not as in the first indication group clopidogrel plus ASA - but for example the preparation Prasugrel as a comparison therapy. The pharmaceutical company has now declared that they will thoroughly review the IQWiG's report internally in order to uncover potential weaknesses. AstraZeneca also refers to the European Medicines Agency (EMA), which confirmed that Brilique had added value in all indications of acute coronary syndrome. However, the preparation was compared only with clopidogrel plus ASA, other existing treatment options were not considered. The same applies to England, Wales, Denmark and Scotland, where the test centers Brilique (Ticagrelor) also confirmed a clear added benefit.

The fact that only in Germany the recommendation for use does not apply to all patient groups of the acute coronary syndrome is a cause for massive criticism for the pharmaceutical company. Other drug manufacturers had already criticized the selection of comparator therapies in earlier approval procedures and made them responsible for the fact that their preparations had no added benefit. However, the approach of the G-BA at this point seems quite understandable, because the new drugs should always be compared with the most efficient treatment method so far, and this can be quite different in the various forms of acute coronary syndrome. (Fp)

Picture: segovax