Avastin and Lucentis are two anti-VEGF drugs with almost the exact same molecular make-up and both have been used to treat wet macular degeneration. The similarities in both Avastin and Lucentis has many experts asking questions.
Off-label drug use is the practice of prescribing a drug for outside the use they were approved for. Any approved drug may be used by a licensed practioner for uses other than those stated on the label. The physician must make decisions based on best judgement and what they have learned about the drugs through medical journals and their colleagues.
With Avastin and Lucentis, the practice of off-label prescribing has a totally different meaning and has fueled the debate.
In 2006, Lucentis (ranibizamab) was approved by the U.S. Food and Drug Adminstration (FDA) as a treatment for wet macular degeneration. Many doctors have argued however, that Avastin (bevacizumab) is as effective as a treatment of wet macular degeneration and it costs considerably less than Lucentis. Avastin is only approved as a cancer drug and not as an FDA approved treatment for wet macular degeneration. Those physicians prescribing this as a treatment for macular degeneration have been prescribing Avastin as an off-label use.
With Avastin and Lucentis, things are not always as they appear. This is more than a simple case of off-label prescribing. Both Avastin and Lucentis are produced by the same pharmaceutical company, Genentech. Lucentis is a direct derivative from the original drug Avastin, with both being almost identical in molecular makeup.
In October 2007, Genentech announced it would limit the supply of Avastin for ocular uses starting January 1, 2008. This announcement led to many outcries from the ophthalmology community, especially since it was felt that Genentech was putting profits ahead of patient care largely because Lucentis costs approximately $2,000 per treatment and Avastin costs appproximately $100 – $150 per treatment. This is compounded by the fact that experts cannot determine the difference in eyes treated with Avastin and eyes treated with Lucentis when both drugs are used to treat macular degeneration.
This has placed many governments in a situation where they must either decide to provide coverage for the more costly drugs or allow the less expensive drug to be used to treat wet macular degeneration. Add to this the pressures that regulating bodies such as the Common Drug Review committee in Canada places on governments by recommending that the provincial health care systems in Canada should provide coverage for Lucentis. Now countries with publicly funded health care systems such as Canada and the UK must make a decision as to whether they will provide the expensive drug Lucentis or balance their costs by allowing physicians to continue to use the off-label Avastin. Governments are concerned with the liabilities that this may pose on them and the physicians, but must strike a fine balance between being fiscally responsible or meeting legally mandated requirements to provide free health care.
The fact that Lucentis costs much more than Avastin has not gone unnoticed. In the United States the Senate Special Committee on Aging had contemplated holding hearings surrounding this controversy of Genentech’s pricing for Lucentis. While this did not occur, Wisconsin Democrat Herb Kohl did call for an investigation into Genentech’s decision to limt the supply of Avastin if it was to be used in treating macular degeneration.
Genentech did lift the restrictions on the supply of Avastin when faced with the threat of hearings and an investigation, and promised to provide free Lucentis for an NIH/National Eye Institute sponsored head-to-head study designed to evaluate Avastin and Lucentis.
This entire controversy will continue for some time until trials and studies into these two closely related drugs continue and the findings are presented and reviewed by experts. Until then, the controversy will continue and it is the patients and governments who pay the ultimate price, one with their vision, their other with their bottom line.
Avastin and Lucentis, two drugs to treat macular degeneration, steeped in controversy and politics.