NICE rejects Alimera's Iluvien for DMO in draft guidance

In draft guidance published today (August 8) by UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) said it is not recommending National Health Service use of USA-based ophthalmic biopharma specialist Alimera Sciences’ (Nasdaq: ALIM) Iluvien (fluocinolone acetonide) intravitreal implant for the treatment of chronic diabetic macular edema (DMO).

The NICE’s independent Appraisal Committee concluded that the manufacturer’s economic models underestimated the incremental cost-effectiveness ratio (ICER) for fluocinolone intravitreal implant. It concluded that a model that relied on more plausible, accurate assumptions would be certain to produce an ICER that exceeded the range that the NICE considers an effective use of NHS resources.

The Committee also concluded that the evidence submitted by the manufacturer did not accurately reflect current clinical practice. For example, the people involved in the trials submitted as evidence may not have been as severely affected by chronic diabetic macular oedema as those patients who would receive fluocinolone intravitreal implant in routine clinical practice, and results from the clinical trials might be better than what would be seen in clinical practice.