NICE has issued a Final Appraisal Determination (FAD) for Lixiana (edoxaban) for the treatment and prevention of recurrent deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults.
The draft guidance states: “Edoxaban is recommended, within its marketing authorisation, as an option for treating and for preventing recurrent deep vein thrombosis and pulmonary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 NHS resources.”
Edoxaban is one of the class of blood-thinning drugs known as non-VKA oral anti-coagulants (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.
After a five-day lead in with heparin treatment, edoxaban can be taken once a day and was shown to have comparable efficacy to warfarin but with a more favourable safety profile.
The term venous thromboembolism (VTE) is used to cover both deep vein thrombosis and the potentially fatal pulmonary embolism. Figures from NICE say there are around 83,500 new cases of VTE each year in England, equating to one in 500 of the population (200 per 100,000 of the population). In addition to new annual cases, there is another group of patients needing long-term treatment. This number is around 42,000.
Therefore, says NICE, the annual number of patients receiving VTE treatment in England stands at some 125,500.
The NICE approval comes shortly after edoxaban received European marketing authorisation for two indications:
- Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.
- Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age≥75 years, diabetes mellitus, prior stroke or transient ischaemic attack.
The NICE FAD called VTE “devastating” and said some patients found the repeated checks needed with warfarin difficult.
“The Committee considered the experience of people with VTE. It noted submissions from clinical and patient experts which stated that the impact of a deep vein thrombosis or pulmonary embolism can be devastating, with patients often hospitalised, restricted in movement and unable to continue with previous activities. When recovering from VTE, patients may need further treatment and monitoring.
Alexander Cohen, consultant vascular physician from Guy’s and St Thomas’ Hospitals, Kings College London, who has researched edoxaban for venous thromboembolism, welcomed an additional resource to tackle the condition. “No two patients are identical and what suits one may not suit another,” he explained. “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 general manager for Daiichi Sankyo, said: “We are very pleased to be able to offer patients and doctors in England and Wales a new easy to use alternative in the treatment armoury against VTE. It is gratifying that NICE has found our therapy to be clinically effective and cost effective within just weeks from receiving our European authorisation.”
Clough added: “NICE has recognised an unmet clinical need among patients with VTE, and this recommendation confirms the value of edoxaban, which combines convenience and safety with features that patients and physicians appreciate.”
The key clinical evidence for edoxaban in VTE came from a global phase 3 study, called Hokusai VTE, which investigated the efficacy and safety of edoxaban compared with warfarin in 8,292 patients with either acute symptomatic deep vein thrombosis, pulmonary embolism, or both. This represents the largest single study carried out to date with a NOAC in this indication.