UK’s NICE panel issues positive appraisal for Iluvien

Alpharetta, GA-The Appraisal Committee of the United Kingdom's National Institute for Health and Care Excellence (NICE) has issued a positive Appraisal Consultation Document (ACD) for the 190 µm fluocinolone acetonide intravitreal implant in applicator (Iluvien, Alimera Sciences) for the treatment of pseudophakic patients with chronic diabetic macular edema (DME) and who are unresponsive to existing therapies.

The ACD recommended a change to the published guidance issued by NICE in January 2013, and took into consideration a simple patient access scheme (PAS) submitted by Alimera for rapid review.

The Appraisal Committee decision reconfirmed the product’s clinical effectiveness in the treatment of vision impairment associated with chronic DME. In the ACD, the committee emphasized, "that the technology had been shown to meet a clinical need in people whose disease is unresponsive to available therapies."

Additionally, the committee noted that, based on the PAS, the cost-effectiveness threshold has been met for a subgroup of chronic DME patients who are pseudophakic or have already undergone cataract replacement surgery.

"I am delighted that the Appraisal Committee has reconsidered the NICE guidance on [the implant]," said Winfried Amoaku, associate professor and consultant ophthalmologist with Nottingham University Hospitals NHS Trust. "Chronic DME patients who are pseudophakic are now one step closer to receiving this crucial sight-saving treatment from the National Health Service.”

Dan Myers, Alimera's president and chief executive officer, was also pleased with the Appraisal Committee's recommendation. He added that Alimera is optimistic that the ACD will lead to a change in the final published guidance.

“We believe that [the implant] is also effective in other groups of DME patients,” Myers said. “We plan to continue to work with NICE to broaden access to Iluvien to include all chronic DME patients who could benefit from the treatment.”

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