Triumphant in Europe at the regulatory stage, Alimera finds that health technology assessment is a different ball game, as NICE turns down Iluvien for diabetic macular edema on two counts.
Alimera Sciences Inc. faces two major hurdles if it is going to obtain a recommendation England’s National Institute of Clinical Excellence for Iluvien (fluocinolone acetonide) intravitreal implant for diabetic macular edema (DME).
The preliminary decision from the National Institute of Clinical Excellence (NICE), published Aug. 8, shot down the drug on two major counts. Firstly, it suggested that the manufacturer’s cost-effectiveness estimates were wide of the mark and, secondly, that the trial population did not adequately correspond to the type of patients in whom the drug would be used in England. On the plus side, though, NICE did conclude that the product was clinically effective.
Although the NICE guidance is only preliminary, the non-recommendation must be viewed as a potentially significant blow for a drug that has yet to be commercialized in any European market and already has suffered a serious regulatory setback in the U.S.
In fact, if NICE’s decision cannot be reversed over the next few months, Iluvien risks the same unwelcome exit from England’s DME market that Novartis AG’s Lucentis (ranibizumab injection) suffered last year.
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