Bayer Schering Pharma welcome NICE’s Final Appraisal Determination (FAD) giving a draft recommendation that Xarelto (rivaroxaban), within its marketing authorisation, is recommended as an option for the prevention of venous thromboembolism in adults having elective total hip or elective total knee replacement surgery. Xarelto is the first of a new generation of anticoagulants – oral direct Factor Xa inhibitors – and is the first oral anticoagulant to demonstrate superior efficacy to the current standard of care, injectable enoxaparin, whilst maintaining a comparable side-effect profile.
Venous thromboembolism (VTE) is a major patient safety issue, causing 10 per cent of all in-hospital deaths in the UK – 25,000 to 32,000 people each year – more than HIV/AIDS, breast cancer, and road traffic accidents combined. This makes VTE one of the leading causes of preventable hospital deaths in the UK. Major orthopaedic surgery is associated with a particularly high risk of hospital-acquired VTE due to the invasive nature of the procedure and the reduced mobility it causes. As a result up to half of the 90,434 people undergoing hip or knee replacement every year in England3 could go on to develop a potentially fatal blood clot if no preventative treatment (known as thromboprophylaxis) were given.
Professor Beverley Hunt, Consultant Haematologist and Medical Director of Lifeblood: The Thrombosis Charity, welcomes NICE’s draft decision: “It is terrific that NICE have reviewed Xarelto® so quickly. A new highly effective oral anticoagulant will encourage the thromboprophylaxis implementation and greatly reduce the risk of hospital-acquired clots after planned major orthopaedic surgery.”
In a large-scale Phase III clinical trial programme involving over 12,500 patients, rivaroxaban became the first oral anticoagulant to demonstrate superior efficacy over the current standard of care (injected enoxaparin). In these trials, rivaroxaban reduced the combined total of VTEs and deaths by between 49-79%. In addition to these efficacy advantages, rivaroxaban has other benefits compared with currently available treatment options because it is given as a one tablet, once-daily, fixed-dose regimen that eliminates the need for any routine monitoring (such as coagulation (clotting), liver function etc) or dose adjustment.
Professor Ajay Kakkar, Professor of Surgical Sciences at the Barts and the London School of Medicine and Dentistry, and Director of the Thrombosis Research Institute, London said, “NICE’s provisional recommendation about rivaroxaban is very encouraging. Venous thromboembolism is the commonest avoidable cause of hospital death. Today’s announcement means we have another effective method to prevent potentially fatal blood clots in orthopaedic surgical patients. In particular we can now facilitate the use of preventative methods out of hospital.”
VTE costs the NHS an estimated £640 million per year.2 A further £19 million of NHS money is spent on litigation from patients who have developed blood clots as a result of a hospital stay or procedure.
In line with normal NICE processes, the NICE recommendation is subject to appeal and correction of factual errors, with final NICE guidance expected in April. Xarelto® was licensed in the UK in October 2008 and received a positive SMC ruling in December 2008.
Source: Bayer Schering Pharma UK
published: March 6, 2009 in: Companies, Hip, Knee, News, Orthopaedics, Products, Specialty