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NICE says Iluvien does not meet cost-effectiveness thresholds
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The National Institute for Health and Clinical Excellence in the United Kingdom has issued its final draft guidance on Iluvien, saying it is not recommended for the treatment of chronic diabetic macular edema considered insufficiently responsive to available therapies because it does not meet cost-effectiveness thresholds, according to a news release.
The Appraisal Committee said that Iluvien (sustained release fluocinolone acetonide, Alimera Sciences) is clinically effective in the treatment of vision impairment associated with chronic DME.
“In recognition of the ongoing process with NICE, we have immediately begun to develop a Patient Access Scheme which, if accepted, will make Iluvien available to all chronic DME patients in the United Kingdom considered insufficiently responsive to available therapies,” Dan Myers, president and CEO of Alimera, said in the release.
The Patient Access Scheme is intended to determine the price point needed to ensure Iluvien treatment decisions will be based on patient need rather than cost, the release said.
The U.K., Austria, France, Portugal and Germany have granted national licenses for Iluvien after Alimera successfully completed the Decentralized Procedure. Iluvien has not been approved by the U.S. Food and Drug Administration.