Pricing and Reimbursement Activities
In July 2012, Alimera received a letter from Germany's Federal Joint Committee (G-BA) indicating that the automatic obligation to submit a dossier on ILUVIEN, per the Arzneimittelmarkt-Neuordnungsgesetz (AMNOG) law, would not be necessary, and that a benefit assessment would not be required. This is due to the fact that fluocinolone acetonide, the active ingredient in ILUVIEN, was available on the German market prior to January 2011. This allows Alimera to launch ILUVIEN in Germany without price restriction.
Alimera recently received an appraisal consultation document from the National Institute for Health and Clinical Excellence (NICE). NICE's preliminary recommendation is that ILUVIEN is not recommended for the treatment of chronic diabetic macular edema given the current cost of £5500 and other variables included in the company's submission. This document is not NICE's final guidance on the technology and the recommendation may change prior to NICE's final appraisal determination (FAD). Alimera, along with NICE's consultants and the public, has the opportunity to provide further comments on the draft appraisal by the end of August in preparation for the second appraisal meeting in September 2012. The NICE FAD is not scheduled until November 2012.
"The news from Germany was excellent, and, as expected, we have received the preliminary guidance from NICE, which provides initial feedback on our submission. We look forward to responding to NICE and working toward a positive recommendation in the FAD in November," said Dan Myers.Conference Call to be Held Today Alimera will hold a conference call today at 4:30 P.M. ET to discuss these results and provide an overall business update. The conference call will be hosted by Dan Myers, president and chief executive officer, and Rick Eiswirth, chief operating officer and chief financial officer. To participate in the call, please dial (877) 369-6586 (U.S. and Canada) or (253) 237-1165 (international). A live webcast will be available on the Investor Relations section of the company's corporate website at http://www.alimerasciences.com . A replay of the conference call will be available beginning August 9, 2012 at 7:30 p.m. ET and ending on August 23, 2012 by dialing (855) 859-2056 (U.S. and Canada) or (404) 537-3406 (international), Conference ID Number: 15550221. A replay of the webcast will be available on the corporate website for two weeks, through August 23, 2012.