NICE has issued a Final Appraisal Determination (FAD) for Lixiana (edoxaban) for preventing stroke and systemic embolism in people with non-valvular atrial fibrillation with the draft guidance stating: “Edoxaban is recommended, within its marketing authorisation, as an option for preventing stroke and systemic embolism in adults with non-valvular atrial fibrillation with one or more risk factors".
Alongside being 75 and over, these risk factors include:
• congestive heart failure
• prior stroke or transient ischaemic attack.
Edoxaban, made by the pharmaceutical company Daiichi Sankyo, is one of the class of blood-thinning drugs known as Novel 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.
Professor Martin Cowie, Professor of Cardiology at Imperial College London and a noted researcher into AF, believes edoxaban gave doctors the ability to better tailor medicines to individual patients.
“A few years ago, all we had to prevent strokes in AF patients was warfarin, which imposes many lifestyle restrictions on patients and needs monitoring with a blood test system known as INR. Now we are spoilt for choice with modern blood-thinning drugs that do not need INR monitoring and are easy for patients to live with,” he said.
Non-valvular atrial fibrillation (AF) is a condition where the heart beats irregularly meaning blood can pool and thicken in the chambers of the heart, causing a risk of clots which then go on to cause strokes. In June 2014 the National Institute for Health and Care Excellence (NICE) published a revised guideline on the management of AF, updating its advice from its original guideline of 2006.
The revised guideline said some 835,000 people in England alone have AF. In addition there may be another 250,000 people who are undiagnosed, according to a NICE press release issued to accompany the guideline. NICE put the prevalence of AF in England at 2% - one in 50 of the population.
The NICE approval comes shortly after edoxaban received simultaneous 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 (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).
NICE issued a FAD for edoxaban for the treatment of deep vein thrombosis and pulmonary embolism, and prevention of recurrent DVT and PE in adults, on 13 July this year.
Dr Simon Clough, UK Managing Director for Daiichi Sankyo, added: "We are very pleased to be able to offer patients and doctors in England and Wales a new convenient to use alternative in the treatment armoury against AF-related illness. It is extremely gratifying that we have received NICE FADs for both AF and VTE within a very short time after gaining European authorisation.
"NICE has recognised an unmet clinical need among patients with AF and this recommendation confirms the value of edoxaban, which combines convenience and safety with features compared to warfarin that patients and physicians appreciate."
The key clinical evidence for edoxaban in AF came from a global phase 3 study, called ENGAGE AF-TIMI 48. The study investigated once-daily edoxaban in comparison to warfarin in 21,105 patients with non-valvular atrial fibrillation (NVAF). This represents the largest and longest trial with a novel anticoagulant in patients with atrial fibrillation performed to date, with a median follow-up of 2.8 years.