Eyeworld

EW INTERNATIONAL 84 February 2016 by Timothy Norris EyeWorld Contributing Writer per patient. According to the SOI, official data show an average of 2.1 injections per patient per year instead of the recommended 7 injections per year. Numbers for ranibizumab grows to 3.6 injections per patient out of the recommended 6 injections. "These results are a concern. We are facing the fact that here in Italy many patients with AMD are doomed to become blind, and this is intolerable," Dr. Piovella said. According to Dr. Piovella, limitations in the use of off-label compounds is preventing physicians from providing their patients with an adequate therapy. "There is this belief that if a company says that a compound can be dangerous, it means that it is really dangerous, even in absence of evidence from the literature. It is un- acceptable that if a physician thinks that a 'dangerous compound' is more indicated, that means that he's voluntarily taking serious hazards while administering the treatment. All of this is unacceptable," Dr. Piovella said. The Italian Society of Ophthalmology is keeping up the struggle to provide access to Avastin in the patients' interests. "We are patiently working on it. The SOI is still waiting for another appeal sentence against these undu- ly strict regulations. There is consen- sus in the ophthalmologic commu- nity about the equivalent efficacy and safety of Lucentis and Avastin, based on scientific evidence," Dr. Piovella said. "We are dealing with an ex- tremely complex, delicate issue, but I think that the SOI has no other choice than to stand up against un- realistic, unfair regulations and de- fend with no exceptions the off-la- bel therapies, and this is absolutely in the patient's interest." EW Editors' note: Dr. Piovella has no finan- cial interests related to this article. Contact information Piovella: piovella@piovella.com despite the verdict from the Euro- pean Court, there are specific and unique regulations in Italy that led to a fall in the use of Avastin, and this is a very disappointing fact," Dr. Piovella said. "Ninety percent of intravitreal therapies in Austria are based on bevacizumab, while in the U.S. the rate is 50/50. In France the health- care system has chosen not to take responsibility, but to let ophthal- mologists decide whether to use bevacizumab or ranibizumab. However, last year 660,000 injec- tions were done in France, 3 times more than in the Italian healthcare system." Authorized centers are still not sufficient in number According to the data published by public health authorities, there are 1,512 authorized centers designated for Avastin with an average funding of $188 million. "These numbers are highly in- accurate because data on the use of Avastin include oncological treat- ment rather than just the use for ophthalmology," Dr. Piovella said. "There is also a lot of inconsistency regarding the number of centers. Some of them are listed twice, and in some cases the number of regional centers exceed the number of physicians qualified for intravit- real treatments. If we reduce the list to the real number, we can barely count 150 centers." Vascularization is a progressive issue, and time matters Both physicians and patients do their best to comply with the injec- tion schedule, but healthcare organi- zation often becomes an obstacle for long-term therapy with Avastin. According to Dr. Piovella, "All this confusion in healthcare proce- dures puzzles patients. Because they are usually older patients, they are more inclined to quit the [treat- ment] if the physicians are strug- gling with strict rules." Average injection rate for patients in Italy is low Another puzzling question comes from the Ministry of Health's data regarding the number of injections proper scientific basis, the potential hazards of using Avastin in favor of the higher safety of Lucentis. This despite the National Institute of Health's declaration that both Avastin and Lucentis were without any doubt equivalent in efficacy and safety," said Matteo Piovella, MD, SOI president. "Access to Avastin is restricted to 58 hospitals, that is 90 out of the 7,000 physicians that could poten- tially use the drug," Dr. Piovella said. Further limitations come from AIFA guidelines on Avastin repackag- ing for ophthalmic use. "Unlike for other compounds, only hospital pharmacies are now allowed to divide the Avastin vial into single sterile units. However, hospitals are not always properly equipped for this kind of service, while there are compounding pharmacies outside hospitals that have the best high-tech laboratories, able to guarantee high standards and efficient services," Dr. Piovella said. Italian public healthcare system Progress in the use of Avastin in ophthalmological procedures, regardless of SOI and Italian physi- cians' efforts, is still very far from European standards. "Despite the Italian Antitrust Authority charging Novartis and Roche with a $200 million fine, Restrictions to access and compounding prevent physicians from providing patients with adequate treatment S tringent regulations in the Italian healthcare system are limiting the use of Avastin (bevacizumab, Genentech, South San Francisco, a member of the Roche group) to only a few public hospi- tals within the category of "centers of excellence," while thousands of patients are undertreated. Due to a strict interpretation of the rule pre- scribing that if a more specific med- icine is approved, it is not possible to freely use an off-label equivalent, Italy is in quite a unique situation compared to the rest of the world. Official restrictions in the use of bevacizumab by the Italian Medicines Agency (AIFA) in 2012 quickly led the Italian Society of Ophthalmology (SOI) to sue Novartis and Roche on the allegation of anti-trust violations. They were accused of colluding to impede the use of Avastin to boast the commercial performance of Lucentis (ranibizumab, Genentech). "The initial error of AIFA in 2012 was to highlight, without a Italian Society of Ophthalmology fights to make bevacizumab available for treatment

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