NICE recommends dexamethasone implant

June 15, 2011

In final draft guidance, the National Institute for Health and Clinical Excellence (NICE) here has recommended an intravitreal implant that delivers 0.7 mg of dexamethasone via an applicator (Ozurdex, Allergan) for the treatment of macular edema (ME) due to central retinal vein occlusion and also for branch retinal vein occlusionin cases in which laser photocoagulation is neither beneficial nor appropriate.

London-In final draft guidance, the National Institute for Health and Clinical Excellence (NICE) here has recommended an intravitreal implant that delivers 0.7 mg of dexamethasone via an applicator (Ozurdex, Allergan) for the treatment of macular edema (ME) due to central retinal vein occlusion and also for branch retinal vein occlusion in cases in which laser photocoagulation is neither beneficial nor appropriate.

NICE, part of the National Health Service (NHS), provides guidance, sets quality standards, and manages a national database to improve people's health and prevent and treat ill health in the United Kingdom.

In its preliminary draft guidance on this appraisal, the NICE committee asked the manufacturer for additional information on the clinical and cost effectiveness of the implant compared with bevacizumab (Avastin, Genentech/Roche). The committee also requested that a revised base case for the cost-effectiveness of dexamethasone be submitted, as well as more detail on the location and extent of macular hemorrhage for the subgroup of patients for whom laser treatment was not considered appropriate.

“After receiving the information requested from the manufacturer following the consultation, we are pleased to be able to recommend dexamethasone intravitreal implant for this condition,” said Peter Littlejohns, NICE clinical and public health director. “Retinal vein occlusion (RVO) can be very debilitating and have a very profound effect on everyday life, so this draft decision will be welcome news to all those affected.”

Douglas D. Ingram, executive vice president and president of Allergan for Europe, Africa, and the Middle East, said, “The decision . . . represents the first NICE recommendation for a licensed treatment for ME associated with RVO, and with it, NICE has made available to retinal specialists and their patients an important treatment for this potentially devastating condition.”

NICE expects to issue its final guidance on the insert in July. Until then, registered stakeholders can appeal the draft recommendations, and NICE has advised NHS bodies to make decisions locally on the funding of specific treatments. Once NICE issues its guidance on a technology, it replaces local recommendations across the country.

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