In the UK, diabetic macular oedema (DMO) has a prevalence of 6.81%1 and, if left untreated, the disease can lead to vision loss. There are several licenced intravitreal therapies approved for use in DMO, including anti-VEGF agents aflibercept (Eylea, Regeneron) and ranibizumab (Lucentis, Novartis), and the steroid implants dexamethasone (Ozurdex, Allergan) and longer-acting fluocinolone acetonide intravitreal implant (Iluvien, Alimera Sciences).
In 2012, Iluvien was licenced in Europe for the treatment of vision impairment associated with chronic DMO considered insufficiently responsive to available therapies.2 This was based on the efficacy and safety data from the FAME (Fluocinolone Acetonide for Diabetic Macular Edema) trials, which showed the implant was particularly effective in chronic DMO patients when compared against the standard of care at the time for DMO3.
However, for a medicine to be reimbursed it needs to be shown to be cost effective. In November 2013, based on the FAME data, the National Institute for Health and Care Excellence (NICE) approved technology appraisal guidance ‘TA301’ and restricted the fluocinolone acetonide implant’s use to the treatment of chronic DMO patients with a pseudophakic lens.
This was based on a cost-to-effectiveness calculation that accounted for costs such as cataract removal surgery and meant Iluvien would be available through NHS England via a patient access scheme.4 This guidance is only effective in the UK, where individual funding requests are required to treat patients that have a phakic lens.