20 February 2015
NICE says yes to dexamethasone for the treatment of common diabetic eye condition in draft guidance
NICE has recommended dexamethasone (Ozurdex, Allergan) intravitreal [1] implant, for the treatment of diabetic macular oedema (DMO) in preliminary recommendations published today (20 February).
The draft guidance recommends dexamethasone as a treatment option in people only where:
- the implant is to be used in an eye with an intraocular (pseudophakic) [2] lens, and
- their diabetic macular oedema does not respond to non-corticosteroid [3] treatment or such treatment is unsuitable for them.
Diabetic macular oedema develops when blood vessels in the eye are damaged by a continuously high blood sugar level, causing plasma leakage. 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 blurring of vision. If it is not treated effectively, it can lead to irreversible vision loss.
The dexamethasone intravitreal implant is injected into the eye once every six months, and 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.
Dr Carole Longson, Health Technology Evaluation Centre Director at NICE said: “NICE is pleased to give the green light to dexamethasone intravitreal implant for some people with diabetic macular oedema in preliminary recommendations. The condition affects around 189,000 people with diabetes in the UK, 39% of whom are eligible for this treatment [4] . This initial decision will be welcome news to both patients and healthcare professionals alike.”
Ends
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Notes to Editors
1. The preliminary draft guidance (appraisal consultation document/ACD) can be found on the NICE website at: /guidance/indevelopment/gid-tag459/documents
2. 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
3. Dexamethasone intravitreal implant (Ozurdex, Allergan) is a corticosteroid (a type of medication that contains steroids) that suppresses inflammation in the eye and prevents oedema.
4. 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’.
5. The cost of a 700-microgram implant and applicator is £870.00 (BNF, edition 68), excluding VAT. One dexamethasone intravitreal implant is administered every 6 months in the affected eye and up to seven implants may be given. 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.
6. 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.
7. 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.
8. NICE technology appraisals apply across the NHS in England and Wales.
9. 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.
10. In April 2013, NICE published technology appraisal guidance that recommended ranibizumab as a possible treatment for some people with diabetic macular oedema. http://www.nice.org.uk/guidance/ta274
11. In November 2013, NICE published technology appraisal guidance that recommended fluocinolone acetonide intravitreal implants as a possible treatment for some people with chronic diabetic macular oedema. /guidance/ta301
12. The Scottish Medicines Consortium is due to publish advice on dexamethasone (Ozurdex, Allergan) intravitreal implant for the treatment of visual impairment due to diabetic macular oedema in May 2015.
References
- Intravitreal refers to the treatment being administered through the eye.
- When an eye is pseudophakic, the natural lens has been surgically removed and replaced by an artificial lens.
- A non-corticosteroid treatment is a type of medication that does not contain steroids.
- Final scope for dexamethasone intravitreal implant for treating diabetic macular oedema, NICE single technology appraisal.
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.
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