ARTICLE | Clinical News

Xarelto rivaroxaban regulatory update

March 19, 2012 7:00 AM UTC

The U.K.'s NICE said it needs additional information before it can recommend the use of Xarelto rivaroxaban from Bayer to treat deep vein thrombosis (DVT) and prevent recurrent DVT and pulmonary embolism following an acute DVT - its approved indication. NICE said the provided data failed to demonstrate Xarelto's clinical and cost effectiveness in the context of U.K. clinical practice. The committee asked for an analysis of patients who required treatment beyond 12 months, including a cost-effectiveness analysis of Xarelto as a life-long treatment. NICE also requested additional data on the cost effectiveness of Xarelto compared with low molecular weight heparin and a vitamin K antagonist in patients who need long-term anti-coagulation.

In January, NICE said it needed additional information before it could recommend the use of Xarelto in its approved indication to prevent stroke and systemic embolism in patients with atrial fibrillation (AF) (see BioCentury, Jan. 16). ...