The National Institute for Health and Care Excellence (NICE), the medicines cost-effectiveness body for England and Wales, has recommended a new treatment to help patients suffering from blood clots in the legs and lungs.
NICE has issued its final recommendation for Lixiana (edoxaban) for the treatment and prevention of recurrent deep vein thrombosis (DVT) and pulmonary embolism in adults.
The NICE recommendation comes after edoxaban received European marketing authorisation in June 2015 for the treatment and prevention of DVT and pulmonary embolism in adults and the prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors (such as congestive heart failure, hypertension, age greater than or equal to 75 years, diabetes mellitus, prior stroke or transient ischaemic attack).
The final NICE recommendation 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.” It adds: “The Committee concluded that edoxaban could be recommended as a cost-effective use of National Health Service resources.”
On 6 August, 2015, NICE also published a Final Appraisal Determination for its Single Technology Appraisal of Lixiana for the prevention of stroke and systemic embolism in people with NVAF.
Edoxaban (Daiichi Sankyo), is a member of the class of blood-thinning drugs known as novel oral anticoagulants (NOACs). The drugs are used as an alternative to warfarin, which has been widely used for over 50 years but requires frequent monitoring to ensure the drug is working properly and is also associated with many food or drug interactions.
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.
Venous thromboembolism—covering both DVT and pulmonary embolism—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 venous thromboembolism 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 venous thromboembolism event, which is reduced with anticoagulant treatment. Without anticoagulant treatment, approximately half of patients who experience an initial event have recurrent one within three months.
According to NICE, there are approximately 83,500 new cases of venous thromboembolism 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.
A 2007 study of morbidity and mortality from venous thromboembolism in six European countries (France, Germany, Italy, Spain, Sweden and the UK) estimated a total of approximately 762,000 episodes of thromboembolism and a further 370,000 related deaths each year. Of these deaths, almost 60% followed undiagnosed and untreated thromboembolism, which suggests that effective treatment could prevent many related deaths.
Alexander Cohen, consultant vascular physician from Guy’s and St Thomas’ Hospitals, Kings College London, who has researched edoxaban for treating venous thromboembolism, 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.”
Simon Clough, UK managing director for Daiichi Sankyo, said: “We are very pleased to be able to offer patients and doctors in England and Wales a new and convenient-to-use alternative in the treatment armoury against venous thromboembolism. It is gratifying that NICE has found our therapy to be clinically effective and cost effective shortly after receiving our European authorisation.”