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NICE has recommended aflibercept (Eylea, Bayer PLC) as an option for the treatment of diabetic macular oedema (DMO) in preliminary recommendations (20 February 2015).

Aflibercept is recommended in people only where:

• the eye has a central retinal thickness of 400 micrometres or more at the start of treatment, and
• the manufacturer  provides aflibercept with the discount agreed in the patient access scheme.

The macula is the central part of the retina responsible for colour vision and perception of fine detail. Diabetic macular oedema is caused when blood vessels abnormally form under the retina and then begin to break down causing plasma to leak into the eye. The leakage is due to a reduction in the amount of connective tissues around the blood vessels and an increased amount of a protein called vascular endothelial growth factor (VEGF). This causes plasma constituents to escape into the surrounding retina which results in a build-up of excess fluid called oedema. The oedema can lead to severe visual impairment in the affected eye.

Aflibercept is a vascular endothelial growth factor inhibitor. It prevents abnormal new blood vessels from forming under the retina. It also helps treat swelling in the retina caused by the build-up of excess fluid (oedema). 

Dr Carole Longson, Health Technology Evaluation Centre Director at NICE said:  “Diabetic macular oedema is a common problem among people with diabetes.  The manufacturer has agreed a patient access scheme which reduces the financial burden of aflibercept on the NHS.  NICE is, therefore, pleased to recommend aflibercept as an additional treatment option for some people with diabetic macular oedema in preliminary guidance.”

Notes to Editors

1. The preliminary draft guidance (appraisal consultation document/ACD) can be found from Friday 20 February on the NICE website at:/guidance/indevelopment/gid-tag472/documents

            Embargoed copies are available to journalists on request. 

      2.   Final guidance is expected to be published in June 2015. 

      3.   For further information on the development of NICE technology appraisals, see the NICE website at: /About/What-we-do/Our-Programmes/NICE-guidance/NICE-technology-appraisal-guidance

      4.   Aflibercept solution for injection (Eylea, Bayer PLC) is a vascular endothelial growth factor (VEGF) inhibitor. It prevents the inappropriate growth of new blood vessels in the retina. Aflibercept solution for injection has a UK marketing authorisation for ‘the treatment of visual impairment in adults due to diabetic macular oedema’.

      5.  Aflibercept is administered as a single 2mg intravitreal injection. Each vial of aflibercept contains a single dose. The list price is £816.00 per vial (excluding VAT; British national formulary [BNF] edition January 2015).

      6.  The company has agreed a patient access scheme with the Department of Health. This scheme provides a simple discount to the list price of aflibercept, with the discount applied at the point of purchase or invoice. The level of the discount is commercial in confidence. The Department of Health considered that this patient access scheme does not constitute an excessive administrative burden on the NHS.

      7.  There were approximately 2.7 million people aged 17 and over diagnosed with diabetes in England in 2013. Diabetic macular oedema affects around 189,000 people with diabetes in the UK, 39% (73,710) of whom are eligible for this treatment. Such people have clinically significant macular oedema (CSMO), which is regarded as the threshold for treatment.  Final scope for dexamethasone intravitreal implant for treating diabetic macular oedema, NICE single technology appraisal. /guidance/gid-tag459/documents/macular-oedema-diabetic-dexamethasone-intravitreal-implant-final-scope2

      8.  People whose treatment with aflibercept is not recommended in this NICE guidance, but was started within the NHS before this guidance was published, should be able to continue aflibercept until they and their NHS clinician consider it appropriate to stop.

      9.  NICE technology appraisals apply across the NHS in England and Wales.

     10. When NICE recommends a treatment 'as an option', the NHS must make sure it is available within 3 months (unless otherwise specified) of its date of publication. The NHS is legally obliged to fund and resource medicines and treatments recommended by NICE's technology appraisals.

     11.  In April 2013, NICE published technology appraisal guidance that recommended ranibizumab as a possible treatment for some people with diabetic macular oedema.  /guidance/ta274  

     12.  In October 2014, the Scottish Medicines Consortium published advice on aflibercept for the treatment of visual impairment due to diabetic macular oedema.  Following a full submission, aflibercept solution for injection (Eylea, Bayer) is accepted for restricted use within NHS Scotland. 

About NICE

The National Institute for Health and Care Excellence (NICE) is the independent body responsible for driving improvement and excellence in the health and social care system. We develop guidance, standards and information on high-quality health and social care. We also advise on ways to promote healthy living and prevent ill health.

Our aim is to help practitioners deliver the best possible care and give people the most effective treatments, which are based on the most up-to-date evidence and provide value for money, in order to reduce inequalities and variation.

Our products and resources are produced for the NHS, local authorities, care providers, charities, and anyone who has a responsibility for commissioning or providing healthcare, public health or social care services.

To find out more about what we do, visit our website:www.nice.org.uk and follow us on Twitter: @NICEComms.