UK accepts additional data for DME implant

Atlanta-The United Kingdom’s National Institute for Health and Clinical Excellence (NICE) is considering an appendix to Alimera Sciences’ comments on the preliminary appraisal consultation document (ACD) previously issued by NICE for the single technology appraisal (STA) of a 90-µg fluocinolone acetonide intravitreal implant in applicator (Iluvien).

NICE’s appraisal committee, which issued the preliminary ACD in August, is evaluating the cost-effectiveness of the implant for the treatment of chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.

On Sept. 4, NICE informed Alimera that the appraisal committee required more time to review the additional data thoroughly. Therefore, the second appraisal committee meeting, previously scheduled for Sept. 11, has been rescheduled for Oct. 11. According to NICE, new data are only accepted for an STA if it is likely to affect the provisional recommendations in the ACD.

As Alimera was drafting its response to the ACD, the company determined that the implant was more cost-effective in a pseudophakic patient subgroup of Alimera’s FAME study, providing additional support to its ACD response submission.

As a result of diabetes, age, or previous DME treatments, each patient in this subgroup had an artificial lens in his or her eye at the start of the study. Patients with an artificial lens cannot further develop a cataract in the treated eye due to their exposure to the corticosteroid delivered via the implant. These patients will not experience the transient reduction in visual acuity as the result of cataract development that occurred in some patients during the first 2 years of the FAME study, nor will they incur the cost associated with cataract surgery.

“We remain hopeful that NICE will recognize [the implant] as a cost-effective therapy for all patients [in whom] chronic DME [is diagnosed that is] insufficiently responsive to currently available therapies,” said Dan Myers, president and chief executive officer, Alimera Sciences. “The NICE appraisal committee’s acceptance of our appendix submission presents the possibility of earlier patient access for patients with limited therapeutic options within the United Kingdom. We look forward to NICE’s review of these subgroup data, and we will continue to work closely with NICE in an effort to make this valuable treatment option available to patients in the United Kingdom as soon as possible.”

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