The UK's National Institute for Health and Clinical Excellence (NICE) has accepted for consideration additional data in the form of an appendix to pSivida's licensee, Alimera Sciences' comments on the preliminary Appraisal Consultation Document (ACD) previously issued by the UK agency for the Iluvien single technology appraisal. NICE's Appraisal Committee, which issued the preliminary ACD in August, is currently evaluating the cost-effectiveness of Iluvien for the treatment of chronic diabetic macular oedema (DMO) considered insufficiently responsive to available therapies.
On 4th September, NICE informed Alimera that the Appraisal Committee required adequate time to thoroughly review the additional data. Therefore, the Second Appraisal Committee meeting, previously scheduled for 11th September 2012, has been rescheduled for 11th October 2012. According to NICE's Guide to the STA, new data is only accepted 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 Iluvien 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 DMO 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 Iluvien. 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 two years of the FAME study, nor will they incur the cost associated with cataract surgery.
Iluvien (fluocinolone acetonide (FAc) intravitreal implant in applicator) is a sustained-release intravitreal implant used to treat chronic DMO. Each Iluvien implant provides a therapeutic effect of up to 36 months by delivering sustained sub-microgram levels of FAc. Iluvien is inserted in the back of the patient's eye to a position that takes advantage of the eye's natural fluid dynamics. The applicator employs a 25-gauge needle, which allows for a self-sealing wound. In the FAME study, the most frequently reported adverse drug reactions included cataract operation, cataract and increased ocular pressure.