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Published on 25 July 2013

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EYLEA® final recommendation by NICE

The National Institute for Health and Care Excellence (NICE) has today announced that EYLEA (aflibercept solution for injection, known in the scientific literature as VEGF Trap-Eye) is recommended for the treatment of patients with wet age-related macular degeneration (wAMD).(1) 

The National Institute for Health and Care Excellence (NICE) has today announced that EYLEA (aflibercept solution for injection, known in the scientific literature as VEGF Trap-Eye) is recommended for the treatment of patients with wet age-related macular degeneration (wAMD).(1) 
EYLEA is the first new medicine in ophthalmology to be fast tracked to Final Appraisal Determination (FAD), without the need for additional consultation. This decision means that eligible patients in England and Wales, who have been newly diagnosed or have not responded well to other medicines, will now have more choice in their wAMD treatment. EYLEA has been shown in two clinical studies to work as well as current treatment, but requires fewer hospital visits,(2,3) reducing the burden for patients, relatives and the NHS.
wAMD is a disease of the elderly(5) and  with 10 million people in the UK being over 65 years old the numbers are set to increase.(6) The latest projections are that there will be 5½ million more elderly people in 20 years time and the number will have nearly doubled to around 19 million by 2050.(6)  A recent study published in the British Journal of Ophthalmology states that approximately 40,000 people are newly diagnosed with wAMD each year in the UK(4) and current estimates predict that there will be more than 450,000 people with the condition by 2015.(7) If left untreated, or inadequately treated, wAMD is the most common cause of blindness in the western world.(8,9)
Advances in wAMD treatment have gone a long way to improve the vision of people with wAMD in recent years, but the need for monthly hospital visits means that fewer than 50% of eye clinics are able to meet waiting times for the first injection(10) and 80% are failing to achieve the four week follow up time required.(10)
Helen Jackman, Chief Executive of the Macular Society comments, “We believe that failure to commission or deliver the appropriate level of care will mean that people will lose their sight and place additional burden on other health and social care services. Sight loss is devastating and all the more so when it is preventable. The approval of Eylea may well help to ease the enormous pressure on eye clinics and bearing this in mind, we hope that this decision will be implemented quickly by the NHS. Demand for this sort of treatment is rising, especially as some patients are opting out of going to their monthly appointments due to the physical, mental, and sometimes financial, strain. Acting quickly to provide appropriate treatment will save people’s sight.”
wAMD distorts central vision, making it blurry with straight lines appearing crooked or wavy. Over time, it may cause a blank patch in central vision.(5) If left untreated or inadequately treated, it can lead to blindness in as little as three months.(11)
wAMD can have a great impact on a person’s quality of life.(12) However, as with most illnesses, early diagnosis and rapid treatment give people the best chance of delaying the progression of wAMD and preventing permanent damage.(13) Mr Moin Mohamed, Consultant Ophthalmologist, St Thomas’ Hospital, London commented, “Being someone who can see normally you just don’t appreciate the impact losing your central vision has on a patient’s life.  Patients lose independence as they can no longer read, watch the television, drive or prepare meals, meaning they have to rely heavily on their family which many patients find difficult to cope with as they don’t want to be a burden. This can lead to a loss of confidence and social isolation, and can lead to a downward circle of decline, this profound impact on a person’s life is often overlooked.”
An investigation by University College London revealed that two thirds of older people with poor vision or registered blind report a ‘bad’ quality of life.(14) A further study also found that older people with poor vision are three times more likely to suffer with depression compared to those with good vision.(15)
Commenting on the positive final guidance from NICE, Dr Sobha Sivaprasad, Consultant Ophthalmologist, King’s College Hospital, London said, “This is a much anticipated decision by NICE as Eylea has the potential to relieve the considerable pressure currently on eye services. A fixed dose injection with Eylea every two months with no monthly monitoring in between is welcome as it can help us to reduce the number of hospital visits for most people. This will not only make life easier for patients with wAMD but it will really help their family members too, many of whom have to repeatedly take time off work to bring their elderly relatives to hospital which can become a financial burden.”
The Government has recently made preventable sight loss a public health indicator with wAMD listed as one of the three conditions being monitored, as it is one of the biggest causes of registerable blindness in England.(16)
The final guidance from NICE on EYLEA means that all eligible wAMD patients in England and Wales will have access to EYLEA on the NHS. The Scottish Medicines Consortium (SMC) has already accepted EYLEA for use within NHS Scotland for the treatment of wAMD.(17)
References
  1. National Institute for Health and Care Excellence. Technology Appraisal 294. Aflibercept solution for injection for treating wet age related macular degeneration. July 2013
  2. Eylea® (VEGF Trap-Eye) summary of product characteristics (SmPC)
  3. Heier JS, et al. Intravitreal Aflibercept (VEGF Trap-Eye) in Wet Age-Related Macular Degeneration. Ophthalmology 2012;119:2537-2548.
  4. Owen CG et al. The estimated prevalence and incidence of late stage age related macular degeneration in the UK. Br J Opthalmol. 2012
  5. RNIB. Age-related macular degeneration. Available at: www.rnib.org.uk/eyehealth/eyeconditions/conditionsac/Pages/amd.aspx. (Last accessed: October 2012)
  6. Cracknall R. The ageing population. Key issues for the new Parliament 2010. House of Commons library research. 2007. Available at: http://www.parliament.uk/business/publications/research/key-issues-for-the-new-parliament/value-for-money-in-public-services/the-ageing-population (Last accessed: July 2013)
  7. Minassian D et al. Modelling the prevalence of age-related macular degeneration (2010-2020) in the UK: expected impact of anti-vascular endothelial growth factor (VEGF) therapy. Br J Ophthalmol. 2011;95(10):1433-1436
  8. Kulkarni AD, Kuppermann BD. Wet age-related macular degeneration. Advanced Drug Delivery Reviews. 57 (2005) 1994- 2009
  9. Boshnick E. Macular degeneration. Available at: http://www.eyefreedom.com/maculardegeneration.php  (Last accessed: October 2012)
  10. Vision 2020. Macular Interest Group. wAMD clinics – survey. Available at: https://www.surveymonkey.com/sr.aspx?sm=2IdxU2xQhIgm1ZZRmuGl_2flqRbIdKfMGxD6D4gTFDOZU_3d (Last access: 22.07.13)
  11. AMD Alliance International. Increasing the understanding of Wet Age-related Macular Degeneration (AMD) as a Chronic Disease. April 2011.
  12. Mitchell J, Bradley C. Quality of life age-related macular degeneration: a review of the literature. Health Qual Life Outcomes. 2006;4:97
  13. US National Eye Institute. National Institutes of Health. Facts about age-related macular degeneration. Available at: www.nei.nih.gov/health/maculardegen/armd_facts.asp#2) (Last accessed: October 2012)
  14. UCL research for Thomas Pocklington Trust. An investigation of the circumstances of older people with sight loss: analysis of the English Longitudinal Study of Ageing., October 2006
  15. Evans JR, Fletcher AE, Wormald RPL. ‘Depression and Anxiety in Visually Impaired Older People’, Ophthalmology vol. 114, 283 – 288, 2007
  16. Amoaku W. Vision 2020 UK Macular Interest Group letter regarding NICE guidance for DMO, NICE TA 274.
  17. Scottish Medicines Consortium. aflibercept 40mg/mL solution for intravitreal injection (Eylea®) SMC No. (857/13). Available at: www.scottishmedicines.org.uk


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