Daiichi Sankyo has announced that NICE has issued its final recommendation for Lixiana (edoxaban) for preventing stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF). This follows NICE’s publication of a Final Appraisal Document on 6 August, for its Single Technology Appraisal of Lixiana for the prevention of stroke and systemic embolism in patients with NVAF.
The NICE recommendation comes shortly after Lixiana received European marketing authorisation in June 2015 for two indications:
– Prevention of stroke and systemic embolism in adult patients with 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.
– Treatment and prevention of recurrent deep vein thrombosis and pulmonary embolism in adults. The NICE final recommendation for this indication was obtained on 26 August.
The final NICE recommendation states: “Edoxaban is recommended, within its marketing authorisation, as an option for preventing stroke and systemic embolism in adults with NVAF with one or more risk factors, including congestive heart failure, hypertension, diabetes, prior stroke or transient ischaemic attack, or 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 NVAF who have one or more risk factors for stroke.”
Edoxaban, made by the pharmaceutical company Daiichi Sankyo, is one of the class of blood-thinning drugs known as novel oral anticoagulants (NOACs). These 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 and drug interactions.
The final NICE recommendation noted: “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 NVAF,” and 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.”
Professor Martin Cowie, professor of Cardiology at Imperial College London and noted researcher of atrial fibrillation, said edoxaban gives 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 measuring international normalised ratio. Now we have choices with modern blood-thinning drugs that do not need international normalised ratio monitoring and are easy for patients to live with.”
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 convenient alternative in the treatment armoury against atrial fibrillation-related illness. NICE has recognised an unmet clinical need among patients with atrial fibrillation and this recommendation confirms the value of Lixiana, which combines convenience and safety compared to well managed warfarin with features that patients and physicians appreciate.”
According to NICE, the estimated prevalence of atrial fibrillation in England is 1.6% of adults aged 18 or over, which equates to approximately 835,000 cases. Of these 835,000 cases, between 476,000 and 702,000 adults could require anticoagulation therapy. In addition, there may be another 250,000 people who are undiagnosed. According to NICE, only an estimated 49.3% of patients with a history of atrial fibrillation are currently receiving anticoagulation therapy.
Atrial fibrillation affects approximately 2.3-3.4% of people in developed nations. More than six million Europeans are diagnosed with the condition, and this figure is expected to at least double over the next 50 years. One in five of all strokes are as a result of atrial fibrillation. Stroke is the second most common cause of death worldwide, responsible for approximately 6.7 million deaths each year.