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NICE consults on a new drug to treat diabetic macular oedema

In draft guidance issued today, NICE has not recommended ranibizumab (Lucentis, Novartis) for treating diabetic macular oedema (DMO).

This draft guidance has been issued for consultation. NICE has not yet issued final guidance to the NHS.

People with diabetes frequently develop macular oedema, which means an accumulation of fluid and swelling within the macula - the central portion of the retina. The macula is full of the specialised nerve endings that detect colour and fine detail. Therefore as macular oedema develops, blurring can occur in the middle of the visual field. DMO can lead to severe visual impairment and, if not treated, blindness.

Ranibizumab, which is given as an injection into the eye, works by preventing the production of a protein called Vascular Endothelial Growth Factor or VEGF. By inhibiting VEGF, ranibizumab can potentially decrease the oedema and limit visual loss or improve vision. The current standard treatment for people with DMO is focal/grid laser photocoagulation.

Commenting on the draft recommendations, Sir Andrew Dillon, Chief Executive at NICE said:” Patients with diabetic macular oedema currently receive laser photocoagulation, a treatment proven to have long term benefits. Although ranibizumab has been shown to be an effective treatment for DMO, and NICE already recommends it for wet age-related macular degeneration, the Appraisal Committee was unable to recommend the drug for this condition because the economic analysis provided by the manufacturer did not reflect clinical practice in a number of respects. Most importantly, it did not account for the need to treat both eyes in a significant proportion of people with DMO, it substantially overestimated the life expectancy of people with diabetes and it underestimated the amount of ranibizumab that people with DMO would have to take in order to achieve the benefits assumed in the analysis. In order to recommend any drug or technology, we need to be sure it represents good value for money; unfortunately in this case the Committee agreed that the evidence did not support a positive recommendation of ranibizumab.

“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.”


Notes to Editors
About the appraisal
1. The draft guidance will be available from 3 March 2011 at:

2. Ranibizumab costs £742.17 per injection. Treatment is given monthly and continued until a patient achieves maximum vision (visual acuity) - that is, the patient's visual acuity is stable over three consecutive monthly assessments performed while on ranibizumab treatment. . Treatment may be resumed when monitoring indicates a loss of visual acuity.

3. The Committee felt that the economic analysis provided by the manufacturer poorly reflected clinical practice in a number of respects. This faulty analysis resulted in highly uncertain cost effectiveness estimates.

Several analyses adopting more plausible assumptions produced ICERs for ranibizumab monotherapy in comparison with laser photocoagulation alone that exceeded £30,000 per QALY. Therefore, the Committee concluded that a more realistic analysis combining all of its preferred assumptions would be certain to produce cost-utility estimates that substantially exceeded the range it could consider to represent an effective use of NHS resources.

About NICE
4. The National Institute for Health and Clinical 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

5. 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 sectorhealth technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHSclinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.6. 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 servicesQuality 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 patients7. NICE provides 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.


Posted: March 2011

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