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Betrixaban for the Prevention of Venous Thromboembolism – First Line

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Betrixaban for the Prevention of Venous Thromboembolism – First Line Horizon Scanning Centre September 2014 Betrixaban for the prevention of venous thromboembolism – first line SUMMARY NIHR HSC ID: 4239 Betrixaban is intended to be used for the first-line prevention of venous thromboembolism (VTE) in acute medically ill patients (including one of the following: congestive heart failure, acute respiratory failure, acute infection without septic shock, acute rheumatic disorders or acute ischemic stroke with lower extremity hemiparesis or hemi paralysis) in the in-hospital and post- discharge settings. If licensed, betrixaban will offer an oral anticoagulant treatment to prevent VTE, in a patient group who do not currently have a licensed factor Xa inhibitor available, and that extends into the post This briefing is discharge period. Betrixaban is a small molecule factor Xa inhibitor which based on acts as an anticoagulant to prevent thrombosis. Factor Xa is a key information component of the coagulation pathway, directly converts prothrombin to available at the time thrombin (factor IIa), via the prothrombinase complex, which in turn converts of research and a fibrinogen to fibrin to form clots. An excess tendency to form clots is an limited literature important contributor to VTE. Betrixaban does not currently have a Marketing search. It is not Authorisation in the EU for any indication. intended to be a definitive statement VTE is a common condition which encompasses pulmonary embolism (PE) on the safety, and deep vein thrombosis (DVT). VTE has an annual incidence of efficacy or approximately 2 in 1,000 population. However, the risk of VTE varies effectiveness of the substantially with age; for people aged under 40 years incidence of VTE is 1 health technology per 10,000 population, whereas for those over 80 years, the incidence rises covered and should to 1 per 100 population. Data indicate that over half of VTE events in not be used for hospitalised medical patients occur after discharge. In 2012-13, there were commercial 23,578 admissions for PE and 18,714 for DVT in England, resulting in purposes or 202,305 and 69,280 bed-days and 45,626 and 25,165 finished consultant commissioning episodes respectively. In 2012, in England and Wales there were 2,075 without additional deaths recorded due to PE and 2,903 due to DVT, however this is likely to be information. an underestimate and could be as high as 25,000 deaths . VTE prophylaxis in patients hospitalised for medical conditions involves assessing the patient’s risk of VTE and applying appropriate prophylactic inventions. These include either pharmacological VTE prophylaxis usually in the form of anticoagulant drugs for those assessed as being at high risk of VTE and low risk of bleeding or mechanical VTE prophylaxis in those where the risk of bleeding is higher than the risk of VTE. Betrixaban is currently in phase III clinical trials comparing its effect on the number of VTE (DVT and/or PE) occurrences and VTE deaths against treatment with enoxaparin. This trial is expected to complete in September 2015. This briefing presents independent research funded by the National Institute for Health Research (NIHR). The views expressed are those of the author and not necessarily those of the NHS, the NIHR or the Department of Health. NIHR Horizon Scanning Centre, University of Birmingham Email: [email protected] Web: http://www.hsc.nihr.ac.uk NIHR Horizon Scanning Centre TARGET GROUP • Prevention of venous thromboembolism (VTE): in acute medically ill patients (one of: congestive heart failure, acute respiratory failure, acute infection without septic shock, acute rheumatic disorders or acute ischemic stroke with lower extremity hemiparesis or hemi paralysis) in hospitalised and post-discharge patients - first line. TECHNOLOGY DESCRIPTION Betrixaban (MK-448; MLN-004; PRT054021) is a small molecule factor Xa inhibitor which acts as an anticoagulant to prevent thrombosis. Factor Xa, a key component of the coagulation pathway, directly converts prothrombin to thrombin (factor IIa), via the prothrombinase complex, which in turn converts fibrinogen to fibrin to form clots1. An excess tendency to form clots is an important contributor to venous thromboembolism (VTE). Betrixaban is intended to be used for the first-line prevention of VTE in acute medically ill patients (including one of the following: congestive heart failure, acute respiratory failure, acute infection without septic shock, acute rheumatic disorders or acute ischemic stroke with lower extremity hemiparesis or hemi paralysis) in both the in-hospital and post-discharge settings. In the phase III clinical trial, betrixaban is administered orally at 80mg once daily for up to 35 days in hospital and post-discharge. Betrixaban does not currently have a Marketing Authorisation in the EU for any indication. Betrixaban is also in phase II clinical trials for stroke prevention in patients with atrial fibrillation. INNOVATION and/or ADVANTAGES If licensed, betrixaban will offer an oral anticoagulant treatment to prevent VTE, in a patient group for whom there is currently no licensed factor Xa inhibitor available, and that extends into the post discharge period. DEVELOPER Portola Pharmaceuticals. AVAILABILITY, LAUNCH OR MARKETING In phase III clinical trials. PATIENT GROUP BACKGROUND VTE, which typically arises from a deep vein thrombosis (DVT) and leads to pulmonary embolism (PE), is a leading cause of morbidity and mortality in hospitalised patients2, the treatment of which creates a considerable cost to the health service3. In DVT a thrombus forms in one of the deep veins, usually of the lower limbs4. Following a DVT, dislodged 2 NIHR Horizon Scanning Centre thrombi may travel to the lungs causing a PE4. PE has the potential to cause sudden death, and those who survive may require intensive care with a recovery that can take several weeks or months. DVT can itself also cause long-term morbidity, such as the development of post-thrombotic syndrome, a chronic disorder which may include pain, heaviness, swelling, cramps, itching, increased skin pigmentation and ulceration of the affected limb4. A number of risk factors, including hereditary factors, can predispose patients to VTE, however hospital-acquired VTE is associated with immobilisation, acute medical illness, surgery, cancer and cancer therapy, trauma, central venous catheters, previous history of VTE, older age and obesity2. The majority of patients hospitalised for medical conditions will have at least one VTE risk factor, and approximately 40% will have three or more risk factors2; prophylactic treatment for VTE is therefore recommended in such patients. NHS or GOVERNMENT PRIORITY AREA This topic is relevant to: • NHS Commissioning Board. Commissioning for quality and innovation (CQUIN): 2013/14 guidance. CLINICAL NEED and BURDEN OF DISEASE The annual incidence of VTE is approximately 2 per 1,000 population and the annual incidence of diagnosed PE in the UK has been reported as 7-8 per 10,000 population5. The risk varies substantially with age; for people under 40 years the annual incidence of VTE is 1 per 10,000, whereas for people aged over 80 years, the incidence rises to 1 in 1002. Data indicate that patients are at particular risk up to 19 days after hospital admission and over half (57%) of VTE events in hospitalised medical patients occur after discharge (US data)6. In addition, people who have had an episode of VTE have a risk of recurrence within 8 years of approximately 30%2. However, the risk of recurrence decreases substantially with time and may vary according to the treatment received2. In 2012-13 there were 23,578 admissions for PE (ICD10 I26.0-I26.9) and 18,714 for DVT (ICD10 I80.1-I80.3) in England, resulting in 202,305 and 69,280 bed-days and 45,626 and 25,165 finished consultant episodes, respectively7. In 2012, in England and Wales there were 2,075 deaths recorded as due to PE (ICD10 I26.0-I26.9) and 2,903 due to DVT (ICD10 I80.1-I80.3)8, however the actual number of those dying from these conditions is likely to be higher due to misdiagnosis and the failure to recognise VTE as the underlying cause9. A report from the House of Commons Health Committee published in 2005 estimated that 25,000 people in the UK die from preventable hospital-acquired VTE each year, including patients admitted to hospital for medical care and surgery10. In 2013, in England there were over 11.4 million prescription items for oral anticoagulants dispensed in the community at a 11 net ingredient cost of almost £43.5 million . Approximately 434,000 prescriptions for parenteral anticoagulants were made in England in 2013 at a net ingredient cost of around £50.3 million11. 3 NIHR Horizon Scanning Centre PATIENT PATHWAY RELEVANT GUIDANCE NICE Guidance • NICE technology appraisal in development. Edoxaban tosylate for the treatment and secondary prevention of deep vein thrombosis and/or pulmonary embolism (ID662). Expected date of issue October 2015. • NICE technology appraisal in development. Apixaban for the treatment and secondary prevention of deep vein thrombosis and/or pulmonary embolism (ID726). Expected date of issue June 2015. • NICE technology appraisal in development. Dabigatran etexilate for the treatment and secondary prevention of deep vein thrombosis and/or pulmonary embolism (ID483). Expected date of issue October 2014. • NICE technology appraisal. Rivaroxaban for treating pulmonary embolism and preventing recurrent venous thromboembolism (TA287). June 2013. • NICE technology appraisal. Rivaroxaban for the treatment of deep vein thrombosis and prevention of recurrent deep vein thrombosis and pulmonary embolism (TA261). July 2012. • NICE clinical guideline. Venous thromboembolic diseases: the management of venous thromboembolic diseases and the role of thrombophilia testing (CG144). June 2012. • NICE clinical guideline. Venous thromboembolism: reducing the risk: Reducing the risk of venous thromboembolism (deep vein thrombosis and pulmonary embolism) in patients admitted to hospital (CG92). January 2010. • NICE quality standard. Quality standard for diagnosis and management of venous thromboembolic diseases (QS29).
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