Alimera Sciences, a biopharmaceutical company that specializes in the R&D and commercialization of prescription ophthalmic pharmaceuticals, said the U.K.'s National Institute for Health and Care Excellence (NICE) Appraisal Committee has issued a positive Appraisal Consultation Document (ACD) on ILUVIEN for the treatment of pseudophakic patients with chronic diabetic macular edema (DME). The ACD recommends a change to the published guidance issued by NICE on January 29, 2013, and takes into consideration a simple patient access scheme (PAS) that was submitted by Alimera for rapid review.
The committee reconfirmed ILUVIEN's clinical effectiveness in the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies.
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 welcome the Appraisal Committee's recommendation on the pseudophakic subgroup,” said Winfried Amoaku, an associate professor and consultant ophthalmologist with Nottingham University Hospitals NHS Trust. “It is hoped that NICE will update its recommendation in the fullness of time to allow access for a wider population of people with chronic DME."
"We are optimistic that this ACD will lead to a change in the final published guidance. We believe that ILUVIEN is also effective in other groups of DME patients, and 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," said Dan Myers, Alimera's president and chief executive officer.