German public health body grant once-daily edoxaban indication for prevention of stroke in non-valvular atrial fibrillation patients



The German Federal Joint Committee (Gemeinsamer Bundesausschuss-G-BA) has granted Daiichi Sankyo’s edoxaban (Lixiana) an indication of a minor additional benefit. The organisation has recognised that the oral, once-daily selective factor Xa inhibitor could aid the prevention of stroke and systematic embolism in patients with non-valvular atrial fibrillation (NVAF).

According to Daiichi Sankyo, this recognition should help to sustain statutory health insurance reimbursement for edoxaban in Germany.

The decision was based on evidence of improved patient outcomes, including fewer bleedings, such as intracranial haemorrhages, and major adverse events following treatment with edoxaban vs. warfarin. This is the first once-daily novel oral anticoagulant (NOAC) to receive recognition for this benefit from the G-BA.

The latest Federal Joint Committee follows full approvals granted by regulators in Scotland, the UK, Switzerland and The Netherlands for indications in prevention of stroke and SE in NVAF.

The Federal Joint Committee’s decision is based on data from a large scale phase III clinical study, ENGAGE AF-TIMI 48, which compared treatment with once-daily edoxaban to warfarin. This study represents one of the largest single comparative trials of a novel oral anticoagulant in this patient population, involving 21,105 patients. In this study, once-daily edoxaban 60mg demonstrated non-inferiority to warfarin, for the primary efficacy endpoint of occurrence of stroke or SE in patients with NVAF (1.18% vs. 1.50% per year, respectively; hazard ratio [HR], 0.79; 97.5% confidence interval [CI], 0.63 to 0.99, p<0.001 for non-inferiority). In addition, once-daily edoxaban 60mg demonstrated a significant 20% risk reduction of major bleeding in patients with NVAF compared to warfarin (2.75% vs. 3.43% per year, respectively; HR, 0.80; 95% CI, 0.71 to 0.91, p<0.001).

After reviewing the available evidence, The Federal Joint Committee has indicated no additional benefit in its appraisal of edoxaban for the prevention of VTE. Oliver Appelhans, Daiichi Sankyo vice president and European launch leader comments, “We remain committed to the use of edoxaban for the prevention of VTE, as supported by the results of the pivotal Hokusai-VTE trial, which demonstrated a significant 19% risk reduction of clinically relevant bleeding in patients with VTE compared to warfarin.”