NICE says yes to Eylea®

Eylea® is the first new medicine in ophthalmology to be fast tracked to draft Final Appraisal Determination (FAD), without the need for additional consultation. This decision means that eligible patients in England and Wales will have an alternative treatment available to them which has been shown in two clinical studies to work as well as current treatment, but requires fewer hospital visits,(2,6) reducing the burden for patients, relatives and the NHS.

Commenting on the positive NICE recommendation, Dr Sobha Sivaprasad, Consultant Ophthalmologist at Moorfields Eye Hospital and King’s College Hospital, London said “This decision will be welcomed by ophthalmologists across England and Wales 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. 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 for most patients. This will make life easier for patients with wAMD and their families, and will also help the NHS planning the future of eye care services.”

In the UK, more than 26,000 people are newly diagnosed with wAMD each year.(7) As it is a disease of the elderly, wAMD is affecting more and more people due to the ageing population, with current estimates predicting that there will be more than 450,000 people with the condition by 2015.(5) If left untreated, or inadequately treated, wAMD is the most common cause of blindness in the western world.(3,4)  Whilst current wAMD therapies have hugely reduced the incidence of blindness, they require monthly hospital visits,(8) placing a continuous burden on patients, relatives and the NHS.(5,8–10)

A recent report from the Royal National Institute of Blind People (RNIB) found that just under 70% of patients were not diagnosed within seven days – in accordance with professional guidance – increasing their chances of permanently losing their central vision.(11)

Mr Ian Pearce, Consultant Ophthalmologist from Royal Liverpool University Hospital added “The decision from NICE to approve Eylea is excellent news for wAMD patients. This is particularly important for those patients who travel long distances for treatment or whose carers and family take repeated time off work to accompany the patient. Once established on therapy, patients will now only need to visit the hospital every two months, allowing them to lead as normal a life as possible. Patients have previously cancelled monthly appointments to avoid making the journey to the hospital, which can potentially jeopardise their 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.(12) If left untreated or inadequately treated, it can lead to blindness in as little as three months.(13)

The impact on a person’s quality of life can be seriously affected by wAMD.(14) 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.(14) With early diagnosis and rapid treatment however, people have the best chance of delaying the progression and preventing permanent damage.(15)

Mr Rob Johnston, Consultant in Ophthalmology from Gloucestershire Hospital welcomes the decision, commenting: “In any therapy area it is important to offer patient choice.  With this positive decision from NICE we are able to provide a cost effective treatment option that fits around a patient’s life and avoids the disruption of never-ending monthly hospital visits while reducing the burden on NHS resources.”

Like current treatments for wAMD, Eylea® is given as an injection into the eye by a trained ophthalmologist.  Treatment in the first year requires one injection every month for the first three months followed by one injection every two months.(2)

Helen Jackman, Chief Executive of the Macular Society said: “We are very pleased that NICE has approved Eylea so quickly. We hope that it will be taken up by the NHS as promptly following final guidance. Eylea may well help to alleviate the enormous pressure in eye clinics. Demand for this sort of treatment is rising and unless patients receive treatment quickly they will lose their sight.”

The draft guidance for Eylea® is now with the consultees, including Bayer Healthcare, national patient and carer groups and bodies representing health professionals, who have the opportunity to appeal the decision if they wish to do so. Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments. Final guidance is likely to be published in July 2013.

The Scottish Medicines Consortium (SMC) accepted Eylea® for use within NHS Scotland for the treatment of wAMD on 8th April 2013.

1. National Institute for Health and Care Excellence. Final Appraisal Determination. Aflibercept solution for injection for treating wet age related macular degeneration. May 2013
2. Eylea® (VEGF Trap-Eye) summary of product characteristics (SmPC)
3. Kulkarni AD, Kuppermann BD. Wet age-related macular degeneration. Advanced Drug Delivery Reviews. 57 (2005) 1994– 2009
4. Boshnick E. Macular degeneration. Available at: http://www.eyefreedom.com/maculardegeneration.php (Last accessed: October 2012)
5. 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
6. Heier JS, et al. Intravitreal Aflibercept (VEGF Trap-Eye) in Wet Age-Related Macular Degeneration. Ophthalmology 2012;119:2537-2548.
7. 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)
8. Lucentis® (ranibizumab) summary of product characteristics (SmPC)
9. Amoaku. The Royal College of Ophthalmologists: Maximising Capacity in AMD Services 2009.
10. Harding SP. Neovascular age-related macular degeneration: decision making and optimal management. Eye. 2010;24:497–505
11. Don’t lose sight! Don’t delay! Perspectives on wet age-related macular degeneration (wetAMD) patient journey, RNIB campaign report https://www.rnib.org.uk/getinvolved/campaign/yoursight/Documents/Wed_AMD_campaign_FINAL.pdf.
12. RNIB. Age-related macular degeneration. Available at: www.rnib.org.uk/eyehealth/eyeconditions/conditionsac/Pages/amd.aspx. (Last accessed: October 2012)
13. AMD Alliance International. Increasing the understanding of Wet Age-related Macular Degeneration (AMD) as a Chronic Disease. April 2011.
14. Mitchell J, Bradley C. Quality of life age-related macular degeneration: a review of the literature. Health Qual Life Outcomes. 2006;4:97
15. 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)