Bristol-Myers Squibb and Pfizer Ltd. have announced that the National Institute for Health and Clinical Excellence (NICE) has issued a fast-tracked Final Appraisal Determination (FAD) recommending the oral anticoagulant Eliquis (apixaban) as an option for preventing stroke and systemic embolism, in patients with non-valvular atrial fibrillation (AF) with one or more risk factors.(1)
The NICE appraisal committee concluded that apixaban was cost effective and more clinically effective for reducing stroke and systemic embolism; and resulted in fewer bleeds than warfarin.(1)
The Single Technology Appraisal (STA) for apixaban has been fast-tracked straight to FAD, bypassing the need for draft guidance for consultation. Apixaban is the only oral novel anticoagulant (NOAC) so far appraised by NICE in this indication to go straight to FAD. 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.
Atrial fibrillation is the most common heart rhythm disorder and is thought to cause approximately 12,500 strokes in the UK/England every year.(2) The risk of strokes can be reduced through adequate anticoagulation,(3) or thinning of the blood, so it is less likely to clot.(4) In the UK, 1.2 million people have AF1 and the prevalence is believed to be growing.(5) The NHS estimates that 46% of AF patients who would benefit from anticoagulation therapy are not currently receiving it.(6) NHS Improvement estimates that up to 4,500 strokes per year and 3,000 deaths may be preventable through improved services and optimal therapy.(6)
“This positive FAD is excellent news for patients with atrial fibrillation in England and Wales,” said Trudie Lobban MBE, founder and CEO of the Atrial Fibrillation Association. “Many patients with atrial fibrillation are currently treated with the anticoagulant warfarin, which requires on-going INR monitoring and can have undesirable interactions with other drugs and diet. Having the choice of effective new treatments which do not require INR monitoring can help reduce the impact that atrial fibrillation has on patients, their families and carers.”
For non-valvular AF related strokes, the NOAC 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.(7)
Amadou Diarra, VP, UK and Ireland, from Bristol-Myers Squibb said on behalf of the Alliance: “NICE’s fast-tracked recommendation confirms the value of apixaban as a cost-effective oral anticoagulant for the prevention of stroke in patients affected by atrial fibrillation. The risk of stroke in these patients is a serious public health concern and through this new treatment option, the Alliance of Bristol-Myers Squibb and Pfizer remains committed to helping reduce the incidence of stroke in patients living with non-valvular AF. Additionally, we are pleased that the novel oral anticoagulants have been selected as a priority area within the NHS Innovation Health and Wealth initiative, seeking to ensure patients have faster and more consistent access to NICE-recommended medicines. We look forward to working with the NHS and other partners to ensure that, where clinically appropriate, patients are provided with rapid access to apixaban, which has been shown to prevent strokes, reduce bleeds and be potentially life-saving compared to the current standard of care, warfarin.”
- 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
- NHS Improvement – Atrial Fibrillation. Available at: http://www.improvement.nhs.uk/heart/AboutAF.aspx Last accessed: 03/01/2013
- Ahmad Y and Lip G. Stroke prevention in atrial fibrillation: Where are we now? Clin Med Insights Cardiol 2012;6:65-78.
- 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: 03/01/2013
- 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.
- Atrial Fibrillation – detection and optimal therapy in primary care. NHS Stroke Improvement Programme.
- Granger CB, et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2011; 365:981-92.