Public release date: 2-Aug-2013 [ | E-mail | Share ]
Contact: Press Office presse@iqwig.de 49-022-135-6850 Institute for Quality and Efficiency in Health Care
The clot-inhibiting drug apixaban (trade name: Eliquis) has been approved in Germany since November 2012 for the prevention of embolism and stroke in adults with non-valvular atrial fibrillation. In an early benefit assessment pursuant to the "Act on the Reform of the Market for Medicinal Products" (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined the added benefit of apixaban.
IQWiG found an indication of a considerable added benefit of apixaban for each of two patient groups: Patients who can also be treated with a vitamin K antagonist (VKA) have a lower risk of dying, stroke or major bleeding than with warfarin treatment. This only applies to people older than 65 years, however. For younger patients, apixaban does not have an advantage. In patients for whom VKA is not an option, stroke and embolism occur less frequently than with acetylsalicylic acid (ASA).
The G-BA distinguishes between two treatment situations
Atrial fibrillation that is not caused by a leaking heart valve is referred to as "non-valvular atrial fibrillation". Apixaban is an option for patients who also have at least one additional risk factor for stroke, such as hypertension or diabetes mellitus.
The Federal Joint Committee (G-BA) distinguished between two treatment situations in its specifications for the appropriate comparator therapy: In patients for whom VKAs were an option (VKA population) apixaban was to be compared with a VKA. If VKAs were unsuitable, apixaban was to be compared with ASA.
The G-BA specified warfarin or phenprocoumon as possible VKAs. Doctors in Germany almost exclusively prescribe phenprocoumon, but better data on the benefit of VKA therapy are available for warfarin. In its dossier, the manufacturer therefore compared apixaban with warfarin.
Both approval studies left questions open
Results of one approval study for each of the two patient groups were available. Although both studies were direct comparative randomized controlled trials (RCTs), they left questions unanswered: In the study that directly compared apixaban with warfarin (ARISTOTLE), results largely differed from country to country, and it is unclear whether they adequately represent the effects of apixaban treatment in Germany. In the study that tested apixaban against ASA (AVERROES), it is unclear whether the results can be applied to all patients independent of their individual risk of complications. In both cases, however, there are no fundamental doubts about the advantages of apixaban so that IQWiG derived an indication of an added benefit in each case.
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Apixaban in atrial fibrillation: Indications of considerable added benefit