Since the European Medicines Agency approval of Lucentis, is the use of Avastin still justified and ethical?

Avastin is reimbursed in Italy

Matteo Piovella

Italy is one of the few European countries where Avastin (bevacizumab, Genentech), and not Lucentis (ranibizumab, Genentech), is reimbursed by the National Health Service. The Italian Society of Ophthalmology (SOI) has played a major role in this decision, and we were aware that we were swimming against the stream. We had our good reasons, stood up for them, and more than 1 year later, we are still convinced that this was the way to go. Until 2 years ago, bevacizumab was considered first-line therapy in AMD. The experience of hundreds of ophthalmologists has shown that it is a safe and effective drug. In addition, it is inexpensive and, therefore, in everybody’s reach. The later modifications that turned bevacizumab into ranibizumab were not proven to be significant in terms of increased safety and efficacy, but the price shot up to an unbelievable 100 times more. I am not discussing the right of the industry to sell its products at whatever price it wants. What I don’t like is the aggressive opposition that is made to those who choose to use the off-label drug rather than the officially approved drug. Using drugs off-label is a right and a well-established practice.

The SOI held a combined session at the 2008 American Academy of Ophthalmology meeting. The American speakers demonstrated no differences between the two drugs except a bit more efficiency for bevacizumab in long-term results. The SOI is an independent organization. We strongly advocate the use of bevacizumab because we are convinced that efficiency criteria and patients’ interests must prevail over commercial interests. In all countries, not just Italy, health authorities and public hospitals have budgets that are not unlimited. Investing in an expensive drug such as ranibizumab means that a huge portion of what is allocated to ophthalmology departments is absorbed by this investment. Therefore, either little is left for other pathologies or few AMD patients can be treated — at least 100 times less than we can potentially treat if we use bevacizumab.

Our insurance department is currently offering 100% coverage for off-label intravitreal use of bevacizumab. We want our associates to have the freedom of choice, without being victimized by the fear and threat of potential medical-legal issues.

Matteo Piovella, MD, is Secretary of the SOI and Associate Editor of the OSN Europe/Asia-Pacific Editorial Board.

Governments should reimburse for Lucentis

Jordi Monés

Since ranibizumab was approved by the EMEA, I think all European governments should make provisions to allow full reimbursement at least in public hospitals. This step has already been taken in most countries. With the current economical crisis, I understand how tempting it can be, on behalf of health authorities, hospital and administrations, to use a cheaper drug. However, we must resist this temptation, or else we will jeopardize the system of drug validation, which is and should be the basis of research and clinical practice. Agencies, such as the FDA and the EMEA, which are aimed at protecting patients from potential dangers of medication, would have no reason to exist. It would be unfair to say that bevacizumab is not a good drug. Ophthalmologists’ experience has proven that bevacizumab does well. It was a revolution that changed our lives and our patients’ lives, and we cannot forget what bevacizumab has done for us in the past 3 years. However, now that we have an approved drug, bevacizumab’s use should be limited to the cases that don’t meet the criteria of the ranibizumab studies, and never just because it is a cheaper drug.

Ranibizumab is expensive, but governments have to face, on a larger scale, the same critical choice that my private patients have: an expensive treatment today or the huge financial burden of a lifelong disability along with the priceless emotional cost of losing vision. In the long run, anti-VEGF treatment, even with an expensive agent such as ranibizumab, is cost-effective for our governments. This cost-effectiveness will be higher if bevacizumab proves to be as safe and effective as ranibizumab, but we need to wait for the results of the CATT study and other trials comparing the two agents. We need the evidence and cannot rely on opinions, impressions and personal views.

Jordi Mones, MD, is a Retinal Consultant at the Teknon Macula Retina Institute, Barcelona, Spain.