NICE has issued its final recommendation for edoxaban (Lixiana) for the treatment and prevention of recurrent deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults.
According to NICE, there are approximately 83,500 new cases of VTE each year in England. This equates to approximately one case per 500 people (200 cases per 100,000). In addition to new annual cases, there is another group of approximately 42,000 patients needing long-term anticoagulation treatment. It states: “Edoxaban is recommended, within its marketing authorisation, as an option for treating and for preventing recurrent deep vein thrombosis and pulmonary embolism in adults. The Committee concluded that edoxaban could be recommended as a cost-effective use of National Health Service (NHS) resources.”
The recommendation comes shortly after edoxaban received European marketing authorisation in June 2015 for two indications:
- Treatment of DVT and PE, and prevention of recurrent DVT and PE in adults
- Prevention of stroke and systemic embolism (SE) in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA).
Once daily edoxaban is initiated after a five day lead in with heparin treatment, in line with current clinical practice. In the pivotal Hokusai-VTE study, edoxaban was shown to have proven efficacy and a significantly better bleeding profile than well-managed warfarin.
The term venous thromboembolism (VTE) is used to cover both DVT and PE. VTE is associated with considerable clinical burden related to recurrence and complications including post-thrombotic syndrome and pulmonary hypertension, and is often fatal. The number of casualties in Europe annually due to VTE is double that of people who die of breast cancer, prostate cancer, AIDS and traffic accidents combined. There is a high rate of recurrence after a first VTE event, which is reduced with anticoagulant treatment. Without anticoagulant treatment, approximately half of patients who experience an initial VTE event have recurrent VTE within three months.
A 2007 study of morbidity and mortality from VTE in six European countries (France, Germany, Italy, Spain, Sweden and the UK) estimated a total of approximately 762,000 VTE episodes and a further 370,000 VTE-related deaths each year. Of these deaths, almost 60% followed undiagnosed and untreated VTE, which suggests that effective treatment could prevent many VTE-related deaths.
Dr Alexander Cohen, Consultant Vascular Physician from Guys and St Thomas Hospitals, Kings College London, who has researched edoxaban for VTE, welcomed an additional resource to tackle the condition. “No two patients are identical and what suits one may not suit another. Venous thromboembolism has a high rate of recurrence, which can be fatal. We need more tools to protect patients from a second incident and edoxaban will be of great use to doctors to help tailor treatments to specific patients.”