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Thursday 27th October 2016

NICE consults on a new drug to treat diabetic macular oedema

4th March 2011

In draft guidance issued today, NICE has not recommended ranibizumab (Lucentis, Novartis) for treating diabetic macular oedema (DMO).

This draft guidance has been issued for consultation.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.”



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