Diabetic macular oedema is a common complication associated with diabetic retinopathy, and is the most common cause of visual impairment in people with diabetes. It develops when blood vessels in the eye are damaged by a continuously high blood sugar level, causing plasma to leak into the eye. Abnormal new blood vessels also form under the retina. This causes a build-up of excess fluid (oedema) in the macular, which is the central part of the retina. The oedema impairs light perception, causing blurred vision. If it is not treated effectively, it can lead to irreversible vision loss.

The final draft guidance recommends aflibercept solution for injection as a treatment option in people only if:

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

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

In the second piece of final draft guidance, dexamethasone intravitreal implant is recommended as a treatment option in people only if:  

• the implant is to be used in an eye with an intraocular (pseudophakic)ⁱⁱ lens,  and
• their diabetic macular oedema does not respond to non-corticosteroidⁱⁱⁱ  treatment or such treatment is unsuitable.

Dexamethasone works by suppressing inflammation and preventing oedema forming in the eye. It reduces plasma leakage from blood vessels and inhibits the release of inflammatory compounds that cause damage to the eye.

The dexamethasone intravitreal implant is injected into the eye, with each implant delivering around 700 micrograms of dexamethasone to the back of the eye over a period of 6 months or more. The implant remains in the vitreous^iv for up to 270 days before fully dissolving. Re-treatment can be performed after approximately 6 months if the patient experiences decreased vision with or without an increase in retinal thickness with recurrent or worsening diabetic macular oedema.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE said:  “NICE is pleased to give the green light to both dexamethasone intravitreal implant and aflibercept as treatment options for some people with diabetic macular oedema in final draft guidance. The condition affects around 189,000 people with diabetes in the UK, and can have a substantial negative impact on quality of life and daily activities. These decisions will therefore be welcome news to both patients and healthcare professionals alike.”

Ends

For more information, please call the NICE press office on 0300 323 0142, or (out of hours) on 07775 583 813.

Notes to Editors

1. The final draft guidance (final appraisal determination / FAD) on aflibercept solution for injection for diabetic macular oedema can be found from Tuesday 2 June on the NICE website at: /guidance/indevelopment/gid-tag472/documents
2. Aflibercept solution for injection (Eylea, Bayer Pharma) 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’.
3. Aflibercept is administered as a single 2mg intravitreal injection every month for 5 consecutive months, followed by 1 injection every 2 months with no requirement for monitoring between visits. After the first 12 months, the treatment interval may be extended based on visual and anatomic outcomes.  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).
4. 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.
5. 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.
6. 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 Pharma) is accepted for restricted use within NHS Scotland.
7. The final draft guidance (final appraisal determination / FAD) on dexamethasone intravitreal implant for diabetic macular oedema can be found from Tuesday 2 June on the NICE website at: /guidance/indevelopment/gid-tag459/documents
8. 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
9. Dexamethasone intravitreal implant (Ozurdex, Allergan) is a corticosteroid (a type of medication that contains steroids) that suppresses inflammation in the eye and prevents oedema.
10. Dexamethasone intravitreal implant has a marketing authorisation in the UK for ‘the treatment of adult patients with visual impairment due to diabetic macular oedema who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for, non-corticosteroid therapy’.
11. The cost of a 700-microgram implant and applicator is £870.00 (BNF, edition 68), excluding VAT. Each implant delivers 700 micrograms dexamethasone to the back of the eye over a period of 6 months or more. The implant remains in the vitreous for up to 270 days before fully dissolving. The summary of product characteristics states that, after initial treatment, re-treatment can be performed after approximately 6 months if the patient experiences decreased vision with or without an increase in retinal thickness with recurrent or worsening diabetic macular oedema. It also states that patients should be monitored following an injection of dexamethasone intravitreal implant. There is currently no experience of the efficacy or safety of repeat administrations in DMO beyond seven implants. Costs may vary in different settings because of negotiated procurement discounts.
12. People whose treatment with dexamethasone intravitreal implant was started within the NHS before this guidance was published, but is not recommended for them by NICE in this guidance, should be able to continue treatment until they and their NHS clinician consider it appropriate to stop.
13. 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. (NICE final scope for aflibercept solution for injection for diabetic macular oedema).
14. NICE technology appraisals apply across the NHS in England.
15. 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.
16. In April 2013, NICE published technology appraisal guidance that recommended ranibizumab as a possible treatment option for some people with diabetic macular oedema.  /guidance/ta274
17. In November 2013, NICE published technology appraisal guidance that recommended fluocinolone acetonide intravitreal implant as a possible treatment option for some people with chronic diabetic macular oedema.  /guidance/ta301
18. In May 2015, the Scottish Medicines Consortium published advice on dexamethasone (Ozurdex, Allergan) intravitreal implant for the treatment of visual impairment due to diabetic macular oedema.  Following a full submission, dexamethasone (Ozurdex, Allergan) intravitreal implant is accepted for use within NHS Scotland.

References

i. Intravitreal refers to the treatment being administered into the eye.

ii. When an eye is pseudophakic, the natural lens has been surgically removed and replaced by an artificial lens.

iii. A non-corticosteroid treatment is a type of medication that does not contain steroids.

iv. The vitreous is a clear, jelly-like substance that fills the middle of the eye.