The FINANCIAL -- Bayer
HealthCare’s oral anticoagulant Xarelto has been
recommended for National Health Service (NHS) use in Final Guidance by
the United Kingdom’s National Institute for Health and Clinical
Excellence (NICE) as a single-drug therapy for the treatment of deep
vein thrombosis (DVT) and the prevention of recurrent DVT and pulmonary
embolism (PE) following an acute DVT in adults.
As Bayer AG reported, in May this year NICE already recommended Xarelto for NHS use for the prevention of stroke and non-CNS systemic embolism in eligible adult patients with non-valvular atrial fibrillation.
Today’s announcement comes shortly after NICE published its Clinical Guidelines on the management of venous thromboembolism, which recognise that the failure to adequately detect and treat VTE can result in devastating patient outcomes, including death.
With the publication of guidance for rivaroxaban, DVT patients can now be treated with a single drug, rather than the existing dual-drug approach of low molecular weight heparin administered by injection, followed by a vitamin K antagonist such as warfarin. The Appraisal Committee acknowledged the limitations of the current dual-drug regimen and recognised the advantages of rivaroxaban in removing the need for routine INR monitoring and for its convenient oral formulation.
The decision by NICE followed a rigorous assessment of both the clinical and cost-effectiveness benefits of rivaroxaban, drawing on the multinational, randomized, event-driven EINSTEIN-DVT and EINSTEIN-EXT studies.
“The NICE endorsement of Xarelto is a significant step forward in the evolution of DVT treatment,” said Dr. Kemal Malik, Member of the Bayer HealthCare Executive Committee and Head of Global Development. “While the current dual-drug therapy of LMWH and VKA is effective, the food and drug interactions and the need for regular anticoagulation monitoring prove challenging in daily clinical practice. The availability of an effective and well-tolerated single-drug therapy that could also potentially improve the quality of life for patients is good news for physicians and patients alike.”
The published NICE Final Appraisal Determination (FAD) will require NHS commissioners in England and Wales to list Xarelto on hospital formularies within 90 days, making it available for clinicians to prescribe for appropriate patients.