NICE has recommended Lixiana (edoxaban) for preventing stroke and systemic embolism in people with non-valvular atrial fibrillation, saying it is a cost effective use of NHS resources.
The draft guidance states: “Edoxaban is recommended, within its marketing authorisation, as an option for preventing stroke and systemic embolism in adults with non-valvular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, including:
- Congestive heart failure
- Prior stroke or transient ischaemic attack
- Age 75 years or older.
It adds: “The Committee concluded that taking all of the analyses into account, edoxaban was cost effective compared with warfarin and could be recommended as an alternative to warfarin for preventing stroke and systemic embolism in people with non-valvular atrial fibrillation who have one or more risk factors for stroke.”
Edoxaban is one of the class of blood-thinning drugs known as Novel Oral Anti-Coagulants. The drugs are used as an alternative to warfarin, which has been widely used for more than 50 years but requires frequent monitoring to ensure the drug is working properly and is also associated with many food or drug interactions.
Martin Cowie, Professor of Cardiology at Imperial College London and a noted researcher into atrial fibrillation, said edoxaban gave doctors the ability to better tailor medicines to individual patients.
“A few years ago, all we had to prevent strokes in [atrial fibrillation] 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.”
The draft Final Appraisal Determination said: “The Committee was aware that non-valvular atrial fibrillation is well-managed with warfarin for many people, but is associated with a number of problems including the need for regular monitoring and dose adjustment, and it has multiple food and drug interactions.
“The Committee accepted the limitations of warfarin therapy and the considerable impact it may have on people who take it, and recognised the potential benefits of edoxaban for people with non-valvular atrial fibrillation.
“The Committee concluded that edoxaban was as clinically effective as warfarin for the primary efficacy outcome of reducing stroke (ischaemic and haemorrhagic) and systemic embolism, and had nearly half the rate of haemorrhagic stroke events compared to warfarin.”
The key clinical evidence for edoxaban in atrial fibrillation 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. 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.
NICE said the trial was of good quality, well designed and generalisable to clinical practice in the UK.
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 with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack.
About non-valvular atrial fibrillation
Non-valvular atrial fibrillation 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.
About 835,000 people in England have atrial fibrillation, while 250,000 people may be living with the condition undiagnosed. NICE estimates the prevalence of atrial fribrillation to be 2% - or 1 in 50.