NICE Final Guidance on Ranibizumab, Pegaptanib for Age-Related Macular Degeneration
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NICE Final Guidance on Ranibizumab, Pegaptanib for Age-Related Macular Degeneration

LONDON -- August 27, 2008 -- The National Institute for Health and Clinical Excellence (NICE) has published its final guidance on the use of ranibizumab (Lucentis) and pegaptanib (Macugen) for the treatment of age-related macular degeneration (AMD).

This means that the appeals against the final draft guidance on the use of these drugs have not been upheld. The guidance recommends ranibizumab as an option for the treatment of wet AMD if all of the following apply in the eye to be treated:

· Best possible visual acuity after correction with glasses or contact lenses is between 6/12 and 6/96.
· There is no permanent structural damage to the central fovea.
· The lesion size is no more than 12 times the size of the area inside the eye where the optic nerve connects to the retina.
· There are signs that the condition has been getting worse.
· The cost of ranibizumab beyond 14 injections is met by the manufacturer. If patients need more than 14 injections per eye, the manufacturer of ranibizumab has agreed to take over the drug cost from the National Health Service.
· Treatment should be stopped if a person's vision gets worse and there are changes inside the eye that show that treatment is not working.

Pegaptanib is not recommended for people with wet AMD. Healthcare professionals should not immediately stop prescribing pegaptanib for patients who were already taking it when the guidance was issued. Patients can continue taking pegaptanib until they and their healthcare professionals decide that it is the right time to stop treatment.

"[Ranibizumab] is an expensive drug … but that cost needs to be balanced against the likely cost savings. AMD results in reduced quality of life and increased risks of illness, particularly in relation to accidents -- especially falls -- and psychological ill-health," said Andrew Dillon, NICE, London, United Kingdom. "Our guidance means that patients who are suitable for this treatment will have the same access to it, irrespective of where they live."

The guidance is available on the NICE website at: http://www.nice.org.uk/TA155

SOURCE: National Institute for Health and Clinical Excellence

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