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Wednesday 19 December 2018
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SMC accepts Eylea® for wAMD

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The Scottish Medicines Consortium (SMC) has announced that Eylea® (aflibercept solution for injection, known in the scientific literature as VEGF Trap-Eye) has been accepted for the treatment of patients with wet age-related macular degeneration (wAMD).(1)

This decision means that eligible patients in Scotland will now have an alternative treatment available to them which works as well as current treatment but requires fewer hospital visits,(2,5) reducing the burden for patients, relatives and the NHS.
 
In the UK, more than 26,000 people are being newly diagnosed with wAMD each year.(6) As it is a disease of the elderly wAMD will affect more and more people due to the ageing population, with current estimates predicting that there will be more than 450,000 people in the UK 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)
Whilst current wAMD therapies have hugely reduced blindness, they require monthly hospital visits,(10) placing a continuous burden on patients, relatives and the NHS.(7,11-12) Of the 1,255 people requiring wAMD treatment in Scotland in 2009, it is estimated that 300 people could have avoided legal blindness if they had received timely treatment.(4)
 
Speaking about the decision, Dr Mike Gavin, Consultant Ophthalmologist, Gartnavel General Hospital, Glasgow said "This decision will be welcomed by ophthalmologists across Scotland as Eylea has the potential to relieve the considerable pressure currently on eye services. The number of wAMD patients is rapidly increasing as people are living longer - we see 20 to 30 new patients a week within the Macula Service in Glasgow. This, along with the monthly hospital visits required by current treatment, is putting a lot of strain on capacity and resources. A fixed dose injection with Eylea every two months with no monthly monitoring in between is a welcome help as it can potentially reduce the number of hospital visits.  This could help us with planning our eye services and make life easier for patients and their families."
 
wAMD distorts central vision, making it blurry with straight lines appearing crooked or wavy. Over time, it may cause a black patch in central vision.(13) If left untreated or inadequately treated, it can lead to blindness in as little as three months.(14)
 
The impact on a person’s quality of life can be seriously affected by wAMD.(15) Simple things that are taken for granted such as recognising faces and daily activities such as driving, reading, watching television, preparing meals and using the telephone become almost impossible.(15) With early diagnosis and rapid treatment however, people have the best chance of delaying the progression and preventing permanent damage.(16)
 
Dr Mike Gavin added "This is great news for wAMD patients in Scotland particularly as many of them have to travel long distances for treatment, with some having to travel by ferry or plane, at considerable cost to the NHS. With current treatment, patients have to endure this journey every month which puts a huge strain on them and their families. Some patients occasionally cancel appointments just to avoid their long journey which can potentially jeopardise their sight. The reduced number of hospital visits with Eylea can benefit patients and their families as, after the first three months of treatment, they only need to visit the hospital every two months, allowing them to lead as normal a life as possible."
 
Like current treatments for wAMD, Eylea® is given as an injection into the eye by a trained ophthalmologist.  Treatment in the first year requires monthly doses for the first three months followed by one injection every two months. After the first 12 months of treatment with Eylea, the treatment interval may be extended based on how the patient is responding.(2)
 
John Legg, Director of sight loss charity RNIB Scotland, said "We welcome any developments that will make access to treatment for age-related macular degeneration easier. AMD is the biggest single cause of sight loss in Scotland.  We have launched a national campaign to highlight how essential it is to get treatment as soon as the symptoms of this condition become apparent. The 'wet' form of AMD can destroy vision in as little as three months if left untreated."
 
The SMC advice represents the first national decision to be published on Eylea® for the treatment of wAMD.(1) Bayer has submitted to the National Institute for Health and Care Excellence (NICE) who will be issuing their full final appraisal document expected in August 2013.
References
  1. Scottish Medicines Consortium. aflibercept 40mg/mL solution for intravitreal injection (Eylea®) SMC No. (857/13). Available at: www.scottishmedicines.org.uk
  2. Eylea® (VEGF Trap-Eye) summary of product characteristics (SmPC)
  3. Macular Disease Society, Scottish Parliament AMD debate. Available at: http://www.maculardisease.org/news.ASP?section=28&sectiontitle=News&item... (Last accessed: March 2013)
  4. RNIB, The Cost of Blindness Scotland: 2010-2020, May 2010 
  5. Heier JS, et al. Intravitreal Aflibercept (VEGF Trap-Eye) in Wet Age-Related Macular Degeneration. Ophthalmology 2012;119:2537-2548.
  6. National Institute for Health and Clinical Excellence. Macular degeneration (age-related) – ranibizumab and pegaptanib (TA155). Available at: www.nice.org.uk/TA155 (Last accessed: October 2012)
  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. Lucentis® (ranibizumab) summary of product characteristics (SmPC)
  11. Amoaku. The Royal College of Ophthalmologists: Maximising Capacity in AMD Services 2009.
  12. Harding SP. Neovascular age-related macular degeneration: decision making and optimal management. Eye. 2010;24:497–505
  13. RNIB. Age-related macular degeneration. Available at: www.rnib.org.uk/eyehealth/eyeconditions/conditionsac/Pages/amd.aspx. (Last accessed: October 2012)
  14.  AMD Alliance International. Increasing the understanding of Wet Age-related Macular Degeneration (AMD) as a Chronic Disease. April 2011.
  15. Mitchell J, Bradley C. Quality of life age-related macular degeneration: a review of the literature. Health Qual Life Outcomes. 2006;4:97
  16. 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)

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