JUL 24, 2013
France’s National Health Authority (NHA) has recommended Iluvien for reimbursement by the French National Health Insurance for the treatment of chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies. Patients will be reimbursed for 100 percent of the cost.
The NHA’s Transparency Commission deemed that Iluvien, a fluocinolone acetonide implant, provides a "moderate medical benefit" as defined by the Service Medical Rendu.
"The Iluvien implant features a sustained-release of the active pharmaceutical agent for up to 36 months, which is in balance with the insidious progression of macular edema due to long-term diabetes mellitus," said Pr. Gisele Soubrane, a clinical investigator for the FAME Study conducted by Alimera and former head of Ophthalmology at the University Hospital of Creteil, Paris XII University. "The clinical results of the trials were significant; Iluvien provides a new, effective mode for achieving vision improvement."
Alimera will now move forward with the next step in the process, which is to determine the price and any reimbursement conditions for Iluvien in France with the Comite Economique des Produits de Sante, or CEPS.
Last month the U.K.’s National Institute for Health and Clinical Excellence (NICE) reversed an earlier decision on Iluvien, saying the treatment is now cost-effective thanks to a new pricing scheme.
Though Iluvien has failed to win approval in the United Sates, it has been licensed for use in several European countries, including Spain, Germany and Austria.