Germany's G-BA recognizes added benefit of Lixiana in stroke and SE prevention

The European subsidiary of Japanese pharma major Daiichi Sankyo (TYO: 4568) revealed on Friday that the German public health agency, the Federal Joint Committee (G-BA), has granted an indication of a minor additional benefit for Lixiana (edoxaban), an oral, once-daily selective factor Xa inhibitor, for the prevention of stroke and systemic embolism (SE) in patients with non-valvular atrial fibrillation (NVAF).

These findings will help to form the basis for the continued reimbursement for Lixiana by statutory health insurance providers in Germany. This recognition has been awarded due to improved patient outcomes, noting fewer bleedings including intracranial hemorrhages and major adverse events following treatment with edoxaban compared to warfarin. Lixiana is the first once-daily novel oral anticoagulant (NOAC), for which the G-BA has recognized an additional benefit.

The decision comes following a positive dossier assessment by the German Institute for Quality and Efficiency in Health Care (IQWiG) last fall (The Pharma Letter November 6, 2015). The latest G-BA view follows full approvals granted by regulators in Scotland, the UK,Switzerland and the Netherlands for indications in prevention of stroke and SE in NVAF.

Oliver Appelhans, Daiichi Sankyo vice president and European launch leader, commented: “The Federal Joint Committee’s decision reinforces the value of edoxaban for this at-risk patient population, and is further evidence of the solid clinical foundations upon which the treatment has been approved in countries throughout Europe.”