pSivida has announced that the United Kingdom’s National Institute for Health and Care Excellence (NICE) has issued draft guidance recommending the company’s ILUVIEN for treating pseudophakic patients (those who have undergone previous cataract surgery) who have chronic diabetic macular edema (DME) that is considered insufficiently responsive to currently available therapies. After a rapid review conducted by NICE, the recommendation has proposed a change to the published guidance previously issued by NICE in January 2013 and takes into consideration a patient access scheme (PAS) that has been submitted by Alimera.
“We are very pleased,” said pSivida CEO Dr. Paul Ashton. “If this recommendation becomes final, ILUVIEN will be available in the U.K. to pseudophakic as well as private pay and privately insured patients. The pseudophakic DME population represents a large subgroup, as patients with DME have a far higher incidence of cataract than the overall population. In the Phase III FAME trials of ILUVIEN, over 50 percent of control patients were pseudophakic at the end of the trial.”
Receiving this recommendation from the NICE Appraisal Committee confirmed conclusions that ILUVIEN is clinically effective in treating vision impairment associated with chronic DME that is considered insufficiently responsive to available therapies, as well as being in the subgroup of pseudophakic chronic DME patients. The committee concluded, based on the PAS, that the cost-effectiveness threshold was met for the subgroup of chronic DME patients who are pseudophakic. Following a comment period, NICE will issue the final guidance.
Around 336,000 individuals with diabetes have diabetic macular edema in the U.K. “NICE is pleased to be able to recommend fluocinolone (ILUVIEN) for some people for the treatment of this condition in draft guidance,” said Professor Carole Longson, director of the Health Technology Evaluation Center at NICE.
pSivida is encouraged by the optimism of Alimera that this recommendation will result in a change in the final published NICE guidance, as well as by Alimera’s plans to continue working with NICE in seeking to broaden ILUVIEN access to include all chronic DME patients who could benefit from the treatment.
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