Bristol-Myers Squibb and Pfizer Ltd. has announced that the Scottish Medicines Consortium (SMC) accepted the novel oral anticoagulant (NOAC) Eliquis (apixaban) for use within NHS Scotland for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) with one or more risk factors.(1)
The SMC concluded that apixaban was superior to warfarin at preventing stroke or systemic embolism and was associated with significantly fewer major bleeds.(1)
Atrial fibrillation is the most common heart rhythm disorder,(3) affecting over 60,000 people in Scotland over the age of 40(2) and with a prevalence that is rising.(4) Those who are affected by atrial fibrillation are approximately five times more likely to suffer from a stroke,(5) and it is estimated that seven percent of all strokes in Scotland are caused by AF.(2) The risk of strokes can be reduced through adequate anticoagulation,(6)or thinning of the blood, so it is less likely to clot.
However, NHS Scotland estimates that less than half (47%) of AF patients at higher risk of stroke are receiving warfarin anticoagulation therapy.(7) Identifying those aged over 40 with AF and treating them with anti-clotting treatments could prevent 960 strokes in Scotland every year, therefore preventing 320 deaths and avoiding significant disability for another 320 stroke survivors.(2)
“The SMC acceptance of apixaban is an important step forward for patients with atrial fibrillation in Scotland,” said Dr Derek Connelly, Consultant Cardiologist in the Royal Infirmary, Glasgow and representative of the Atrial Fibrillation Association. “Many Scottish patients are being treated with the anticoagulant warfarin which, needs on-going INR monitoring and can have many undesirable reactions with other drugs and diet. The availability of a new treatment option that does not require INR monitoring may help decrease the impact atrial fibrillation has on the quality of life of patients, their families and carers in the prevention of stroke.”
For non-valvular AF related strokes, apixaban has been shown to be more effective than warfarin at preventing strokes or systemic embolism, has been associated with less major bleeding and resulted in more lives saved.(8) The SMC guidance also notes that apixaban requires no therapeutic monitoring, which would reduce the workload of services associated with warfarin monitoring and potentially reduce the risks to the patient associated with poor INR control. The guidance also notes that apixaban is associated with fewer interactions than warfarin.(1)
Amadou Diarra, VP and General Manager, UK and Ireland, from Bristol-Myers Squibb said on behalf of the Alliance, “The SMC’s acceptance confirms the value of apixaban as a clinically and cost-effective oral anticoagulant for the prevention of stroke in patients affected by non-valvular atrial fibrillation. The risk of stroke in these patients is a serious public health concern and through this new treatment option, the Alliance of Pfizer and Bristol-Myers Squibb remains committed to helping reduce the incidence of stroke in patients living with non-valvular AF.”
The National Institute for Health and Clinical Excellence (NICE) has also issued a Final Appraisal Determination (FAD) recommending apixaban as an option for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) with one or more risk factors.(9)
The FAD forms the basis of the final guidance to the NHS in England and Wales and, pending no change, is expected in February, 2013. Once the final guidance is published the NHS will be legally obliged to implement it within 90 days. Both SMC and NICE have already accepted apixaban for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery.(10,11)
Apixaban was licensed for use in the European Union in November 2012 for the prevention of stroke and systemic embolism in adult patients with non-valvular AF and one or more risk factors such as: prior stroke or transient ischaemic attack; age 75 years or older; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).(12)
Apixaban’s licence for stroke prevention in non-valvular atrial fibrillation is supported by the pivotal ARISTOTLE and AVERROES studies.(8,13) ARISTOTLE evaluated apixaban vs. warfarin in 18,201 patients with non-valvular AF who were suitable for warfarin,(8) and AVERROES evaluated apixaban vs. aspirin in 5,599 patients with non-valvular AF who were considered unsuitable for warfarin.(13)
Apixaban is also licensed for the prevention of venous thromboembolic events in adult patients who have undergone elective hip or knee replacement surgery.(14)
About Atrial Fibrillation (AF)
AF is the most common type of heart arrhythmia(3) where the heart beats irregularly allowing blood to pool in the left atrium which may result in the formation of a clot.(15) These clots can break off and travel through the bloodstream to smaller blood vessels in the brain where it can cause a stroke.(15)
Stroke due to AF is more severe and stroke recurrence is more frequent in patients with AF than in patients without AF. Additionally, ischaemic strokes associated with AF are nearly twice as likely to be fatal as non-AF related strokes.(16) Because atrial fibrillation is often asymptomatic and may be clinically undetected, the stroke risk attributed to atrial fibrillation may be substantially underestimated.(5) Up to one-third of patients with atrial fibrillation report no obvious symptoms.(17) The risk of stroke can be reduced substantially through the recognition of AF(18) and adequate pharmacological anticoagulation therapy.(6)
- Scottish Medicines Consortium. apixaban 2.5mg and 5mg film-coated tablets (Eliquis®) SMC No. (836/13). www.scottishmedicines.org.uk. Live from 11th February, 2013.
- NHS Scotland. Health in Scotland 2007. Annual report of the Chief Medical Officer. Available at: http://www.scotland.gov.uk/Resource/Doc/249854/0072285.pdf Last accessed: 07/02/13
- NHS Improvement – Atrial Fibrillation. Available at: http://www.improvement.nhs.uk/heart/AboutAF.aspx Last accessed: 31/01/2013
- Banach M, et al. The significance of preoperative atrial fibrillation in patients undergoing cardiac surgery: preoperative atrial fibrillation – still underestimated opponent. Europace 2008 10: 1266 – 70.
- Roger VL, et al. Heart disease and stroke statistics-2012 Update: A report from the American Heart Association. Circulation. 2012 Jan 3;125(1):e2-e220.
- Ahmad Y and Lip G. Stroke prevention in atrial fibrillation: Where are we now? Clin Med Insights Cardiol 2012; 6:65-78.
- NHS Scotland. Heart Disease Improvement Programme, National Overview – Take Heart. Healthcare Improvement Scotland. September 2011. Available at: http://www.nhsaaa.net/media/140598/hisheartd.pdf Last accessed: 07/02/13
- Granger, CB et al. Apixaban versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med. 365:981-992. 2011
- National Institute for Health and Clinical Excellence, Final appraisal determination Apixaban for preventing stroke and systemic embolism in people with non-valvular atrial fibrillation, Issue January 2013 Available at http://www.nice.org.uk/nicemedia/live/13652/62421/62421.pdf Last accessed: 07/02/13
- The Scottish Medicines Consortium (SMC) assessment on apixaban 2.5mg film-coated tablet (Eliquis®), SMC No. (741/11) Available at: http://www.scottishmedicines.org.uk/SMC_Advice/Advice/741_11_apixaban_Eliquis/apixiban_Eliquis Last accessed: 07/02/13
- National Institute for Health and Clinical Excellence, Final appraisal determination Apixaban for the prevention of venous thromboembolism after total hip or knee replacement in adults, Issue November 2011 Available at: http://guidance.nice.org.uk/TA/Wave21/17/FAD Last accessed 07/02/13
- Eliquis (5mg) Summary of Product Characteristics. Available at: http://www.medicines.org.uk/EMC/ingredient/2651/apixaban/ Last accessed: 31/01/13
- Connolly SJ et al. Apixaban in patients with atrial fibrillation. N Engl J Med 2011 364(9):806-17.
- Eliquis (2.5mg) Summary of Product Characteristics. Available at: http://www.medicines.org.uk/EMC/ingredient/2651/apixaban/ Last accessed: 31/01/13
- The Stroke Association. Atrial Fibrillation (AF) and Stroke. Factsheet 26. Available at: http://www.stroke.org.uk/sites/default/files/Atrial%20fibrillation%20(AF)%20and%20stroke.pdf, Last accessed: 31/01/2013
- Huey et al. Stroke Severity in Atrial Fibrillation. The Framingham Study. Stroke 1996; 27 (10): 1760-4.
- Savelieva I et al. Silent Atrial Fibrillation – Another Pandora’s Box. Pacing Clin Electrophysiol. 2000 Feb; 23(2):145-8.
- Atrial Fibrillation – detection and optimal therapy in primary care. NHS Stroke Improvement Programme.