Xarelto is a cost-effective alternative to the current standard of care in patients undergoing total hip and total knee replacementGeschreven op 17.07.2009
Cost-Effectiveness Data Presented at ISTH Confirm Clinical and Economic Value of Xarelto®
July 15, 2009 - The economic value attributable to the novel oral anticoagulant, Xarelto® (rivaroxaban), taken as one tablet, once-daily for the prevention of venous thromboembolism (VTE) was highlighted in various abstracts presented at the XXII Congress of the International Society on Thrombosis and Haemostasis (ISTH) in Boston, USA.1,2 Analyses based upon an economic model demonstrated that giving Xarelto following elective total hip (THR) or knee replacement surgery (TKR) achieves better patient outcomes at a lower overall cost than enoxaparin. This further strengthens the growing body of evidence for Xarelto, an oral, direct Factor Xa inhibitor, licensed for the prevention of VTE in adult patients undergoing elective THR or TKR surgery. Xarelto has been approved in more than 50 countries worldwide since the first approval was granted in September 2008.
"The cost of treating patients who suffer complications associated with VTE following surgical procedures can be high - especially if a period of re-hospitalization is required," said Frank Misselwitz, MD, Vice President of Global Clinical Development and Head of the Therapeutic Area Cardiovascular and Coagulation at Bayer Schering Pharma AG. "These data demonstrate that Xarelto provides superior health outcomes for the patient and can result in cost savings for healthcare systems."
Two economic analyses, based upon an economic model, presented at ISTH compared Xarelto with subcutaneous enoxaparin for VTE prevention after THR or TKR. These analyses found Xarelto to provide patients with improved health outcomes at a lower overall cost.1,2
"These health economic studies confirm that Xarelto has the potential to save costs for healthcare providers and payers, which is particularly important at a time when the reimbursement costs of innovative new treatments are under intense scrutiny, on a global scale." said Dr. Phil Wells, Professor and Chief Department of Medicine, Division of Hematology and Clinical Epidemiology, Ottawa Health Research Institute/University of Ottawa, Canada.
The first economic analysis investigated the cost-effectiveness of Xarelto versus enoxaparin in the United Kingdom (UK) and Sweden over a five-year period.1 The model assessed data from the Phase III RECORD Program:3,4,5,6; RECORD1 was the base case in THR3 and the RECORD3 data were used for the TKR base case5. Recurrent VTE and post-thrombotic syndrome were included based upon values from published literature. Costs were obtained from published sources in each country and outcomes were expressed according to quality-adjusted life years (QALYs), a measure of disease burden including both the quality and the quantity of life lived.
When equal durations of Xarelto and enoxaparin were compared in THR, Xarelto showed per-patient savings over five years of approximately €124 in the UK and €4 in Sweden.1 Xarelto patients also showed clear improvements in health outcomes, as measured by QALYs. In TKR, Xarelto achieved improved outcomes and per-patient savings over five years of approximately €145 in the UK and €81 in Sweden.1
The second economic analysis was conducted in Canada from the perspective of the Ministry of Health over a five-year period. The risk of VTE and post-thrombotic syndrome were estimated for up to five years after surgery using published data.2 As with the analyses for the UK and Sweden, RECORD1 and RECORD3 were used as base cases for THR and TKR respectively.3,5 Costs, including savings from oral administration, were derived from published sources and expressed in Canadian dollars.
The results of the Canadian analyses mirrored those in the UK and Sweden. When equal durations of Xarelto and enoxaparin were compared in THR, Xarelto showed greater benefit at a lower cost, with savings of C$264 per patient.2 Compared with enoxaparin, Xarelto also improved health outcomes while achieving cost savings of C$107 per patient following TKR.2
The economic model used for these analyses has been developed in partnership with key clinical economic experts, using data from the Phase III RECORD clinical trial program3,4,5,6 and published clinical and epidemiological literature.
About Venous Thromboembolism (VTE)
Blood clots can break apart and travel through the bloodstream, blocking blood flow to vital organs. VTE includes DVT, a blood clot in a deep vein (usually in the leg), and PE,
a blood clot in the lung, both of which are serious, life-threatening - but often preventable - conditions. Patients undergoing major orthopedic surgery are at high risk for VTE because during hip or knee replacement procedures, the large veins of the leg that carry blood back to the heart can be damaged, significantly increasing the risk of developing a clot. In fact, venous blood clots occur in 40 to 60 percent of patients undergoing major orthopedic surgery who do not receive preventive care. In the five largest EU-member states, approximately 450,000 total hip - and approximately 300,000 total knee replacement surgeries are being conducted annually.
About the RECORD Clinical Trial Program3,4,5,6
RECORD is a global program of four trials in more than 12,500 patients, comparing Xarelto (rivaroxaban) and enoxaparin in the prevention of venous thromboembolism (VTE) after elective (planned) hip or knee replacement surgery. Data from four distinct Phase III trials within the RECORD program showed superior efficacy of Xarelto, both in head-to-head comparisons with enoxaparin (RECORD1, 3 and 4) and when comparing extended-duration (5 weeks) Xarelto with short-duration (2 weeks) enoxaparin (RECORD2). In all four individual trials, Xarelto and enoxaparin had similar safety profiles, including low rates of major bleeding.
Xarelto was invented in Bayer's laboratories in Wuppertal, Germany, and is being jointly developed by Bayer HealthCare and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Xarelto is approved in the European Union for the prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. Additional approvals have been granted in other countries, including Australia, Canada, China, Mexico and Singapore. To date, Xarelto has been launched in more than 30 countries around the world by Bayer Schering Pharma.
The extensive clinical trial program supporting rivaroxaban makes it the most studied oral, direct Factor Xa inhibitor in the world today. More than 65,000 patients are expected to be enrolled into the rivaroxaban clinical development program.
To learn more about thrombosis, please visit www.thrombosisadviser.com.
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