_{10 Oct 2012}

NICE publishes new draft guidance on ranibizumab for diabetic macular oedema after rapid review

In new draft guidance issued (5 October) for consultation, NICE, the healthcare guidance body, has recommended ranibizumab (Lucentis, Novartis) as an option for treating visual impairment caused by diabetic macular oedema (DMO). NICE conducted a rapid review of the original guidance, published in November 2011, because the manufacturer submitted a revised Patient Access Scheme, together with updated analyses including the drug's superior relative effect among a sub-group of people with DMO.

Ranibizumab  is recommended as an option for treating diabetic macular oedema only if:

• people have a central retinal thickness of 400 micrometres or more, and
• the manufacturer provides ranibizumab with the discount agreed as part of the patient access scheme (as revised in 2012).

People currently receiving ranibizumab whose disease does not meet these criteria should be able to continue therapy until they and their clinician consider it appropriate to stop.

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 increased permeability of the blood retinal barrier. 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.

Ranibizumab, which is given by injection into the eye, works by preventing the production of VEGF. By inhibiting VEGF, ranibizumab can decrease the oedema and limit visual loss or improve vision.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE said: "Our current guidance on the use of ranibizumab for treating visual impairment caused by diabetic macular oedema, published in November 2011, does not recommend the drug as an effective use of NHS resources. However, following the submission of a revised patient access scheme, we have conducted a rapid review of the original guidance. The manufacturer included updated analyses showing that ranibizumab could be expected to have a superior relative effect among people with central retinal thickness greater than 400 micrometres. This draft guidance recommending ranibizumab for some patients with diabetic macular oedema is now available for consultation."

NICE has not yet issued final guidance to the NHS; these decisions 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 expected to be published in February 2013.