Although Avastin (bevacizumab) is FDA-approved for treating certain types of cancer, retinal specialists have been using it off-label for treating neovascular AMDbut at a lower cost than its sister drug Lucentis (ranibizumab), which was specifically made and FDA approved for treating AMD.

However, access to Avastin will become much more limited. Genentech, which manufactures both drugs, announced last month that as of January 1, 2008, it will no longer allow compounding pharmacies to purchase this product directly from wholesalers. 

In an open letter to the retinal community, Susan Desmond-Hellmann, M.D., M.P.H., Genentechs president, product development, said that several events led to this decision. These include FDA approval of Lucentis for AMD use and concerns raised by the FDA about the sterility and repackaging of Avastin for ocular use.

In addition, we note that Avastin has not undergone any formal, randomized, controlled clinical trials for ocular use, said Dr. Desmond-Hellmann.

Lucentis and Avastin each bind to and inhibit all forms of VEGF-A. In 2005, researchers at Bascom Palmer Eye Institute in Miami found that Avastin was effective in treating a small cohort of AMD patients. Since then, several thousand AMD patients have received the off-label therapy.

It is extremely unfortunate that Genentech has chosen to do this, says Mark Dunbar, O.D., of Bascom Palmer Eye Institute. They relate that the reason is a concern expressed by the FDA of possible microbial contamination. In the peer-reviewed literature in 2007, there are at least 160 citations so far, and at ARVO in 2007, there were 222 abstracts demonstrating the safety and efficacy of intravitreal Avastin. Based on evidence in the worlds literature, it appears that intravitreal Avastin is in fact very safe. Until a prospective clinical trial is conducted, there is no way to tell which drug is better.  

Such a clinical trial is in the works. Last year, the National Eye Institute and National Institutes of Health announced they would support a two-year study to compare the relative safety and effectiveness of Avastin and Lucentis.

But, there is one major difference between the drugs: cost. A single injection of Lucentis costs approximately $2,000 per dose, while a single injection of Avastin is less than $100.

Clearly this decision by Genentech appears to be based not on safety but really on economics, Dr. Dunbar says. Unfortunately, it will be the patient who will pay the price.

Not so, says Genentech. We understood that some would disagree with our decision to stop supplying Avastin to compounding pharmacies and would accuse Genentech of making profit, not patients, its priority, the company said in a second open letter. Genentechs decision was not motivated by a desire for increased profits. We did not and do not expect that this change in policy toward compounding pharmacies will lead to any increase in Lucentis sales.

The company offers a support program dedicated to facilitating timely reimbursement, and the Genentech Access to Care Foundation (GATCF), which provides Lucentis at no cost not only to qualified patients with wet AMD, but also to qualified patients with other ocular diseases that can lead to blindness.

Genentech previously told Review of Optometry that 81% of patients have enough insurance (Medicare and a supplemental policy or private insurance with a fixed copay) to bring the cost of Lucentis to $50 or less per treatment.

In its follow-up letter, the company said it expects Avastin to be available and that physicians will continue to prescribe it for ocular indications. Further, Genentech senior executives met with leaders from the American Academy of Ophthalmology and American Society of Retina Specialists and have promised once again to supply Avastin to compounding pharmacies, should the FDA give the company legal and regulatory authorization to do so.

Vol. No: 144:11Issue: 11/15/2007