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The Transparency Commission of the French National Authority for Health has issued a favorable opinion for the reimbursement and hospital listing of Alimera Sciences’ fluocinolone acetonide intravitreal implant (Iluvien) for the treatment of chronic diabetic macular edema.
Atlanta-The Transparency Commission (Commission de la Transparence [CT]) of the French National Authority for Health (Haute Autorité de Santé) has issued a favorable opinion for the reimbursement and hospital listing of Alimera Sciences’ fluocinolone acetonide intravitreal implant (Iluvien) for the treatment of chronic diabetic macular edema (DME).
The commission’s opinion allows the French National Health Insurance to reimburse patients with chronic DME for treatment when their disease is considered insufficiently responsive to available therapies. French patients will be reimbursed for 100% of the cost of the intravitreal implant under a specific program (Affection de Longue Duree) designed for severe chronic diseases, such as diabetes.
When comparing the clinical benefit of the fluocinolone acetonide intravitreal implant with existing therapies (Amelioration du Service Medical Rendu [ASMR]), the CT rated the product at “level IV.” In 2012, only 11.6% all new products under CT initial review received an ASMR rating of level IV or better.
Alimera, based in Atlanta, plans to move forward in the process, which is to determine the price and any reimbursement conditions for the fluocinolone acetonide intravitreal implant in France with the Comite Economique des Produits de Sante (CEPS).
“We are pleased to receive the CT’s positive opinion for reimbursement of [the fluocinolone acetonide intravitreal implant],” said Dan Myers, president and chief executive officer of Alimera. “We believe this opinion will help us in our discussions with the CEPS pricing committee, as we work to make [the fluocinolone acetonide intravitreal implant] available to those suffering from chronic DME in France.”
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