Bayer HealthCare's oral anticoagulant Xarelto® (rivaroxaban) has today 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. 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 (AF).
Today's announcement comes shortly after NICE published its Clinical Guidelines on the management of venous thromboembolism (VTE), 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 (LMWH) administered by injection, followed by a vitamin K antagonist (VKA) 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.
About Venous Arterial Thromboembolism (VAT)
Thrombosis is the formation of a blood clot inside a blood vessel, blocking a vein (venous thrombosis) or artery (arterial thrombosis). Venous Arterial Thromboembolism (VAT) is caused when some or all of a clot detaches and is moved within the blood stream until it obstructs a smaller vessel. This can result in damage to vital organs, because the tissue beyond the blockage no longer receives nutrients and oxygen.
VAT is responsible for a number of serious and life threatening conditions:
- Venous Thromboembolism (VTE) occurs when part of a clot formed in a deep vein, for example in the leg (known as deep vein thrombosis, or DVT), is carried to the lung, via the heart, preventing the uptake of oxygen. This is known as a pulmonary embolism (PE), an event which can be rapidly fatal
- Arterial Thromboembolism (ATE) occurs when oxygenated blood flow from the heart to another part of the body (via an artery) is interrupted by a blood clot. If this occurs in a vessel supplying blood to the brain, it can lead to a stroke, an event that can be severely debilitating or fatal. If it occurs in a coronary artery, it can lead to acute coronary syndrome (ACS), a complication of coronary heart disease which includes conditions such as myocardial infarction (heart attack), and unstable angina
VAT is responsible for significant morbidity and mortality, and requires active or preventative treatment to avoid potentially serious or fatal patient outcomes.
About Rivaroxaban (Xarelto®)
Rivaroxaban is an oral anticoagulant that was discovered in Bayer HealthCare's Wuppertal laboratories in Germany, and is being jointly developed by Bayer HealthCare and Janssen Research & Development, LLC. It has a rapid onset of action with a predictable dose response and high bioavailability, no requirement for routine coagulation monitoring, and limited potential for food and drug interactions.
Rivaroxaban is marketed under the brand name Xarelto® for VTE prevention in adult patients following elective hip or knee replacement surgery, and it is the only oral anticoagulant that has consistently demonstrated superior efficacy over enoxaparin in this indication. Rivaroxaban is approved in more than 120 countries worldwide and is marketed outside the U.S. by Bayer HealthCare in this indication. In December 2011, Xarelto® received further marketing approval in the EU and has since then been approved in more than 50 countries worldwide for the prevention of stroke and systemic embolism in patients with Atrial Fibrillation, as well as for the treatment of deep vein thrombosis (DVT) and the prevention of recurrent DVT and pulmonary embolism following an acute DVT in adult patients.
In the U.S., where rivaroxaban has been available since July 2011 for VTE prevention in adult patients following elective hip or knee replacement surgery, Bayer's cooperation partner Janssen Pharmaceuticals, Inc. (a Johnson & Johnson Company) holds marketing rights. The Bayer HealthCare sales force is supporting Janssen Pharmaceuticals, Inc. in designated hospital accounts. In November 2011, Xarelto® received further marketing approval in the U.S. to reduce the risk of stroke and systemic embolism in patients with nonvalvular Atrial Fibrillation.
The extensive clinical trial program supporting rivaroxaban makes it the most studied and widely published oral, direct Factor Xa inhibitor. The studies involve nearly 100,000 patients for the prevention and treatment of venous and arterial thromboembolic (VAT) disorders across a broad range of acute and chronic conditions, including VTE prevention in adult patients following elective hip or knee replacement surgery, stroke prevention in patients with Atrial Fibrillation, VTE treatment and the prevention of recurrent DVT or PE, and for secondary prevention after an Acute Coronary Syndrome.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 17.2 billion (2011), is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare's aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 55,700 employees (Dec 31, 2011) and is represented in more than 100 countries.