NICE says yes to treatment for common eye problem in people with diabetes in final guidance
In final guidance published by NICE, fluocinolone acetonide intravitreal implant (Iluvien, Alimera Sciences) is recommended as an option for the treatment of chronic diabetic macular oedema considered insufficiently responsive to available therapies only if the implant is to be used in an eye with an intraoculari (pseudophakicii) lens.
Chronic diabetic macular oedema causes blurred or double vision and affects around 14% of people with diabetes in the UK.
The macula is the central part of the retina at the back of the eye responsible for seeing colour and fine detail. Diabetic macular oedema occurs as a result of the abnormal growth of new retinal blood vessels in people with diabetes. A reduction in the amount of connective tissue around the capillaries and an increased amount of a protein called vascular endothelial growth factor (VEGF) causes the blood retinal barrier to become more permeable. This leads to leakage of plasma in the surrounding retina, causing a build-up of excess fluid and swelling (oedema) which disrupts the fovea, the area responsible for sharp vision. It can lead to severe visual impairment in the affected eye.
Fluocinolone acetonide intravitrealiii implant is recommended as an option for treating chronic diabetic macular oedema that is insufficiently responsive to available therapiesivonly if:
- the implant is to be used in an eye with an intraoculariii (pseudophakiciv) lens, and
- the manufacturer makes it available to the NHS under the terms agreed with the Department of Health as part of a patient access scheme.
NICE's original guidance, published in January 2013, did not recommend fluocinolone. NICE conducted a rapid review of this guidance because the manufacturer submitted a patient access scheme, which is a scheme proposed by a pharmaceutical company and agreed between the company and the Department of Health. It provides a discount to the list price of fluocinolone to the NHS and aims to improve its cost-effectiveness.
Professor Carole Longson, Health Technology Evaluation Centre Director at NICE said: "NICE is pleased to be able to recommend fluocinolone for some people with diabetic macular oedema. The condition affects around 14% of people with diabetes in the UK, and can cause blurred or double vision, so this will be welcome news to both patients and healthcare professionals alike."
The final guidance can be found from: 00:01hrs on Wednesday 27 November 2013 on the NICE website.
Embargoed copies are available on request; please contact the press office.
This is NICE's final guidance on this technology and now replaces local recommendations across the country.
For more information, please call the NICE press office on 0845 003 7782, and (out of hours) on 07775 583 813, or email firstname.lastname@example.org
Notes to Editors
i. An intraocular lens is an artificial lens implanted in the eye.
ii. When an eye is pseudophakic, the natural lens has been surgically removed and replaced by an artificial lens.
iii. Intravitreal refers to the treatment being administered via the eye.
iv. There are currently no standard treatments for people with chronic diabetic macular oedema after other therapies have failed. NICE recommend Ranibizumab for the treatment of diabetic macular oedema (rapid review of technology appraisal 237) in some people, but it does not cover the treatment of people with unresponsive disease. (NICE technology appraisal guidance 274, 2013).
v. A corticosteroid is a type of medication that contains steroids.
About the guidance
1. The final guidance can be found from: 00:01hrs on Wednesday 27 November 2013 on the NICE website.
Embargoed copies are available on request; please contact the press office.
2. Fluocinolone acetonide intravitreali implant is a corticosteroidv which has anti-inflammatory and anti-vascular endothelial growth factor (anti-VEGF) properties. Fluocinolone can decrease the oedema and limit visual loss and/or improve vision. The implant releases fluocinolone acetonide for up to 36 months.
3. Fluocinolone acetonide intravitreal implant has a marketing authorisation for the treatment of vision impairment associated with chronic diabetic macular oedema considered insufficiently responsive to available therapies
4. Each fluocinolone acetonide intravitreal implant contains 190 micrograms of fluocinolone acetonide, releasing 0.2 micrograms/day for up to 36 months.
5. The summary of product characteristics states that the recommended dose of fluocinolone acetonide is 1 implant in the affected eye. Only patients whose disease has been insufficiently responsive to treatment with laser photocoagulation or other available therapies for diabetic macular oedema should be treated. Administration in both eyes concurrently is not recommended.
6. Fluocinolone acetonide intravitreal implant is available in a 190-microgram implant at a price of £5500 (excluding VAT; 'British National Formulary' [BNF] 65th edition). Costs may vary in different settings because of negotiated procurement discounts.
7. The manufacturer of fluocinolone acetonide intravitreal implant has agreed a patient access scheme with the Department of Health in which fluocinolone acetonide intravitreal implant will be available with a discount. The details of the scheme were provided as commercial in confidence.
8. The Committee concluded that fluocinolone acetonide intravitreal implant showed greater clinical effectiveness than sham injection in people with chronic diabetic macular oedema.
9. The Committee concluded that fluocinolone acetonide intravitreal implant had been shown to be clinically effective in the subgroup of people with chronic diabetic macular oedema who had treatment in an eye with a pseudophakic lens.
10. The Committee noted that for the psudophakic subgroup, the ICERs were £30,000 per QALY gained using the utilities from Brown et al. (1999), £21,000 per QALY gained with the utilities from Czoski-Murray et al. (2009) and £17,500 per QALY gained with the utilities from Brown et al. (2000). It was persuaded that the technology had been shown to meet a clinical need in people whose disease is unresponsive to available therapies. Therefore, the Committee concluded that fluocinolone acetonide intravitreal implant was a cost-effective use of NHS resources and recommended it as an option for treating people with chronic diabetic macular oedema that is insufficiently responsive to available therapies and who had treatment in an eye with a pseudophakic lens.
11. Approximately 14% (336,000) of people in the UK with diabetes have diabetic macular oedema and prevalence increases to 29% (696,000) for people with diabetes who use insulin for more than 20 years.
12. NICE technology appraisals apply across the NHS in England and Wales.
13. For further details on NICE technology appraisals, please see the NICE website.
Related NICE guidance
1. Aflibercept solution for injection for treating wet age-related macular degeneration. NICE technology appraisal guidance (2013).
2. Ranibizumab for the treatment of diabetic macular oedema (rapid review of technology appraisal 237). NICE technology appraisal guidance 274 (2013).
3. Ranibizumab for treating visual impairment caused by macular oedema secondary to retinal vein occlusion NICE technology appraisal guidance 283 (2013).
4. Dexamethasone intravitreal implant for the treatment of macular oedema secondary to retinal vein occlusion. NICE technology appraisal guidance 229 (2011).
5. Ranibizumab and pegaptanib for the treatment of age-related macular degeneration. NICE technology appraisal guidance 155 (2008).
6. The management of type 2 diabetes. NICE clinical guideline 87 (2008).
7. Type 1 diabetes: diagnosis and management of type 1 diabetes in children, young people and adults. NICE clinical guideline 15 (2004).
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This page was last updated: 25 November 2013