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NICE gives EYLEA a provisional green light to treat patients with visual impairment due to diabetic macular oedema

is pleased that NICE has recognised the benefits of (aflibercept solution for injection) for the treatment of due to diabetic () according to a draft decision released 19 February.1 However, Bayer is disappointed that a core group of patients diagnosed with early stage DMO (central retinal thickness <400 micrometres) would be denied treatment until their disease has progressed to a stage where permanent damage to the eye has already begun. Bayer is committed to working with NICE throughout the appraisal process to ensure all DMO patients have access to EYLEA when the decision is finalised; expected in June 2015.

Dr Sobha Sivaprasad, Consultant Ophthalmologist, Moorfields Eye Hospital and King’s College Hospital London added: “It is good news that we may potentially have Eylea as a further effective treatment option for many patients experiencing visual impairment due to DMO; however it is frustrating that whilst we are able to diagnose the disease early through the diabetic retinal screening programme we are still unable to effectively treat patients until their DMO progresses. The level of vision in patients who are diagnosed early tends to be good and prompt treatment will help maintain this vision by preventing further damage due to DMO. Another treatment option available for those with early stage DMO includes laser therapy which is not very effective and can even lead to deterioration of vision, meaning the decision is often made to leave patients and monitor them for disease progression until they can receive alternative treatment options.”

DMO occurs in some people that have diabetic retinopathy, a complication of diabetes affecting the eye. Approximately 50,000 people could be affected by DMO,2 however this is set to increase significantly with the expected growth of the diabetes population; adding to what is already a major public health issue.3, 4 If not treated effectively, DMO can result in vision loss and this can have an impact on the day-to-day lives of patients, carers and their families. It can jeopardise financial security, due to the loss of employment and dependence on benefits, and impact a patient’s psychological well-being due to depression and social isolation.1 It can also significantly impact a patient’s ability to manage their glucose levels. It is therefore vitally important that this disease is diagnosed and treated early to minimise its impact on a patient’s health and well-being.

EYLEA was licensed in the UK for the treatment of wet age related macular degeneration (wAMD), an eye condition affecting the elderly, in November 20125 and was accepted by the SMC for this use within NHS Scotland in April 2013.6 It was recommended by National Institute for Health and Care Excellence (NICE) for the treatment of wAMD on the NHS in England and Wales in July 2013.7

EYLEA was also licensed in the UK for the treatment of visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO), a serious condition affecting the main vein in the eye, in August 20138 and NICE recommended it for this use in February 2014.9 It was accepted by the SMC for use within NHS Scotland for the treatment of visual impairment due to macular oedema secondary to CRVO in April 2014.10 Funding for EYLEA is now mandated across England and Wales for the treatment of eligible patients with wAMD and visual impairment due to macular oedema secondary to CRVO.7, 9

The UK licence for EYLEA for the treatment of visual impairment due to DMO was granted in August 2014,8 with the SMC accepting it for restricted use in this indication in November 2014.11


1. NICE. Appraisal Consultation Document – Aflibercept for treating diabetic macular oedema. February 2015

2. Diabetes UK. NICE recommends use of Lucentis for NHS treatment of vision loss. Available at: http://www.diabetes.org.uk/About_us/News_Landing_Page/NICE-recommends-use-of-Lucentis-for-NHS-treatment-of-vision-loss/ (Last accessed: February 2015)

3. RNIB. Understanding eye conditions relating to diabetes. Available at: http://www.rnib.org.uk/eye-health-eye-conditions-z-eye-conditions/understanding-eye-conditions-related-diabetes (Last accessed: February 2015)

4. Help Diabetes, National Institute for Health Research, Rising obesity causes number of diabetes to double in 20 years. Available at: http://www.researchforthefuture.org/2013/09/rising-obesity-causes-number-of-diabetes-cases-to-double-in-20-years/ (Last accessed: July 2014)

5. Eylea (VEGF Trap-Eye) summary of product characteristics (SmPC)

6. Scottish Medicines Consortium. aflibercept 40mg/mL solution for intravitreal injection (Eylea®) SMC No. (857/13). Available at: http://www.scottishmedicines.org.uk (Last accessed: February 2015)

7. National Institute for Health and Care Excellence. Technology Appraisal 294. Aflibercept solution for injection for treating wet age related macular degeneration. July 2013

8. European Medicines Agency. Eylea (Aflibercept). Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Procedural_steps_taken_and_scientific_information_after_authorisation/human/002392/WC500148632.pdf(Last accessed: February 2015)

9. National Institute for Health and Care Excellence. Final Appraisal Determination. Aflibercept for treating visual impairment caused by macular oedema secondary to central retinal vein occlusion. February 2014

Source: Bayer HealthCare