ARTICLE | Clinical News

Ozurdex dexamethasone intravitreal implant regulatory update

June 13, 2011 7:00 AM UTC

The U.K.'s NICE issued a final appraisal determination (FAD) recommending use of Allergan's Ozurdex dexamethasone intravitreal implant to treat macular edema following central retinal vein occlusion (CRVO) and following branch retinal vein occlusion (BRVO) when laser photocoagulation is not beneficial or suitable. The FAD reverses a February preliminary appraisal that recommended against Ozurdex and requested additional information on the clinical and cost-effectiveness of the biodegradable implant compared with bevacizumab, which is not yet approved for the indication in the U.K. Ozurdex is approved in the U.K. to treat macular edema following CRVO and BRVO (see BioCentury, Feb. 14).

NICE said that a clinical efficacy advantage for Ozurdex over bevacizumab could not be determined on currently available evidence. However, based a revised cost-effectiveness analysis from Allergan, the committee concluded that the most plausible incremental cost-effectiveness ratio (ICER) for Ozurdex compared with best supportive care would be £26,300 ($43,179) per quality-adjusted life year (QALY) gained. It is generally accepted that a technology must have an incremental cost less than or equal to £20,000-£30,000 per QALY for the agency to consider it cost-effective. ...