In draft guidance published today (8 August) by the healthcare guidance body, NICE, fluocinolone acetonide intravitreal implant (Iluvien, Alimera Sciences) is not recommended for the treatment of chronic diabetic macular oedema (DMO).

The macula is the central part of the retina responsible for colour vision and perception of fine detail. DMO occurs as a result of changes in retinal blood vessels in people with diabetes. A reduction in the number of connective tissues around 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 constituents in the surrounding retina, causing a build-up of excess fluid (oedema) which disrupts the fovea, the area responsible for sharp vision. It can lead to severe visual impairment in the affected eye.

Fluocinolone acetonide intravitrealⁱ implant is a corticosteroidⁱⁱ which has anti-inflammatory and anti-vascular endothelial growth factor (anti-VEGF) properties. By inhibiting VEGF, fluocinolone can decrease the oedema and limit visual loss and/or improve vision. The implant releases fluocinolone acetonide for up to 3 years.

The independent Appraisal Committee concluded that the manufacturer's economic models underestimated the incremental cost-effectiveness ratio (ICER) for fluocinolone intravitreal implant. It concluded that a model that relied on more plausible, accurate assumptions would be certain to produce an ICER that exceeded the range that NICE considers an effective use of NHS resources.

The Committee also concluded that the evidence submitted by the manufacturer did not accurately reflect current clinical practice. For example, the people involved in the trials submitted as evidence may not have been as severely affected by chronic diabetic macular oedema as those patients who would receive fluocinolone intravitreal implant in routine clinical practice, and results from the clinical trials might be better than what would be seen in clinical practice.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE said: “The independent Appraisal Committee is aware that chronic diabetic macular oedema can have a significant effect on the physical and emotional wellbeing of people affected. Unfortunately in this case, the Committee agreed that the evidence provided could not support a positive recommendation of fluocinolone intravitreal implant. These draft recommendations are now available for public consultation and the manufacturer and other consultees are able to consider and respond to concerns and comments made by the Appraisal Committee.”

NICE has not yet issued final guidance to the NHS. Consultees and commentators now have the opportunity to comment on these draft recommendations and consequently they may change after consultation.

Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its guidance on a technology it replaces local recommendations across the country.

Final guidance is likely to be published in November 2012.

Ends.

Notes to Editors

References

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

ii. A corticosteroid is a type of medication that contains steroids.

About the guidance

1. The draft guidance (appraisal consultation document/ACD) is available on the NICE website from 00:01hrs on Wednesday 8 August.

Consultees and commentators have until Thursday 30 August to submit their comments.

2. 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

3. Each fluocinolone acetonide intravitreal implant contains 190 micrograms of fluocinolone acetonide, releasing 0.2 micrograms/day for up to 36 months.

4. The summary of product characteristics states that the recommended dose of fluocinolone acetonide is 1 implant in the affected eye every 3 years. 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.

5. An additional implant may be administered after 12 months if the patient experiences decreased vision or an increase in retinal thickness secondary to recurrent or worsening diabetic macular oedema.

6. The manufacturer's submission states that the acquisition cost of a fluocinolone acetonide intravitreal implant is £5500 (excluding VAT) per 190-microgram implant (source: Alimera Sciences). Costs may vary in different settings because of negotiated procurement discounts.

7. Approximately 14% (336,000) of people in the UK with diabetes have DMO and prevalence increases to 29% (696,000) for people with diabetes who use insulin for more than 20 years.

8. The SMC has yet to publish advice on fluocinolone acetonide intravitreal implant for chronic diabetic macular oedema.

9. Further details on NICE technology appraisals.

Related NICE guidance

Published

1. Ranibizumab for the treatment of diabetic macular oedema. NICE technology appraisal guidance 237 (2011). Available from www.nice.org.uk/guidance/TA237

2. Dexamethasone intravitreal implant for the treatment of macular oedema secondary to retinal vein occlusion. NICE technology appraisal guidance 229 (2011). Available from www.nice.org.uk/guidance/TA229

3. Ranibizumab and pegaptanib for the treatment of age-related macular degeneration. NICE technology appraisal guidance 155 (2008). Available from http://nice.org.uk/guidance/TA155

4. Type 2 diabetes - newer agents (partial update of CG66). NICE clinical guideline 87 (2008). Available from www.nice.org.uk/guidance/CG87

5. Type 1 diabetes: diagnosis and management of type 1 diabetes in children, young people and adults. NICE clinical guideline 15 (2004). Available from www.nice.org.uk/guidance/CG15

6. There is no NICE guidance related specifically to treating chronic diabetic macular oedema.

Under development

NICE is developing the following guidance (details available at: www.nice.org.uk):

7. Aflibercept solution for injection for the treatment of wet age-related macular degeneration. NICE technology appraisal guidance (publication expected August 2013).

8. Ranibizumab for the treatment of macular oedema caused by retinal vein occlusion. NICE technology appraisal guidance (publication date to be confirmed).

About NICE

1. The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health.

2. NICE produces guidance in three areas of health:

public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector.

health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS.

clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

3. NICE produces standards for patient care:

quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services

Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients.

4. NICEprovides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.