Italy approves bevacizumab for reimbursement, sparking controversy

On May 28, bevacizumab was officially approved by Italian authorities for intravitreal use in treating "exudative maculopathy and neovascular glaucoma." It will be fully reimbursed by the National Health Service in Italy.

This provision is beginning to raise some controversy within the ophthalmology community.

While intravitreal bevacizumab (Avastin, Genentech) has not withstood the scrutiny of multicenter, randomized clinical trials, its efficacy has been tested in practice; however, its safety is still a controversial issue, according to an Italian ophthalmologist.

In Italy, other anti-VEGF agents are currently only available as "class C" medications, which means they can only be purchased and administered by hospitals, without NHS reimbursement.

In an interview with Ocular Surgery News, Paolo Lanzetta, MD, associate professor at Udine University, said, "Pegaptanib (Macugen, OSI/Pfizer) and ranibizumab (Lucentis, Genentech), following a rigorous process of validation according to the highest levels of evidence as defined by evidence-based medicine, have received the approval of the U.S. [Food and Drug Administration] and [European Medicines Agency]. They could therefore be available to the benefit of our patients' vision.

"In reality," he said, "the Italian Pharmaceutical Agency (AIFA), the organization that 'facilitates the access to innovative medications and promotes the safe and appropriate use of medications,' has denied the reimbursement of pegaptanib and ranibizumab, which have been specifically developed and researched and validated for ocular use."

According to Dr. Lanzetta, the decision also raises a number of other issues.

"What does exudative maculopathy mean? This is not a definition of a disease but rather a description of a morphological condition secondary to many diseases of the retina," he said. "Do we have enough evidence for using bevacizumab in all of those conditions? How should we use Avastin in our patients?"

In an announcement published on its Web site, the Italian Society of Ophthalmology (SOI) reacted favorably, attributing much of the merit of this "important provision" to the intensive work of its Technical and Ethical Committees, to the work of the society at the governmental level and to the foresight of the AIFA.

Matteo Piovella, MD, secretary of the SOI and an OSN Associate Medical Editor, said in this statement that SOI has pursued this objective "to promote the right of a large number of patients to make use of a treatment opportunity from which they would be otherwise excluded."

He also said SOI pursued this "to avoid situations like the one created in the U.S., where Avastin is the most commonly used intravitreal therapy, but ophthalmologists must justify its use with diagnoses that do not correspond to reality."

Ocular Surgery News will continue to follow this breaking news and will report more fully on it in an upcoming issue.