Alimera Sciences announced that it has received the pricing and reimbursement decree for Iluvien from Agenzia Italiana del Farmaco (AIFA) on January 11, 2017. The decree, published February 2, 2017, in the Gazzetta Ufficiale della Repubblica Italiana, the official journal of record of the Italian government, changed the reimbursement status of Iluvien from Class C, in which the patient covers the cost of the treatment, to Class H, with a restriction to patients with an artificial lens implanted. This means that in Italy, Iluvien will be hospital-administered and should be fully reimbursed for those patients who have previously undergone cataract surgery. In Europe, Iluvien is a sustained-release intravitreal implant for the treatment of vision impairment associated with chronic diabetic macular edema (DME).
"With this decree we have reached a major milestone. We now have our first price set in Southern Europe, and have a clear path to a new revenue stream with our distributor, Societa Industria Farmaceutica Italiana (SIFI)," Dan Myers, Alimera's chief executive officer, said in a company news release. "We believe Iluvien is the only therapy that treats DME consistently every day due to its continuous microdosing for up to three years, and we are pleased with this outcome."
Iluvien will be distributed throughout Italy, San Marino and Vatican City by SIFI. Under the terms of the 5-year agreement signed in August 2015, SIFI is handling all promotion, marketing and commercial activities in those geographies for Iluvien, and was responsible for the successful pursuit of the Class H designation.
"At SIFI, we strive to offer Italian ophthalmologists and their patients a full range of products to address their eye care needs," Fabrizio Chines, executive chairman of SIFI SpA, said in the news release. "Iluvien is a wonderful complement to our existing portfolio. We believe Iluvien is the most advanced technology for sustained drug release with continuous microdosing providing a physician the only therapy to treat the disease consistently every day. It represents a real innovation in DME treatment both for physicians and patients because providing a consistent daily dose makes patient compliance and adherence to therapy easier, reduces the risks of multiple intravitreal injections, and thus we believe provides a clear improvement in the patient's quality of life."