WASHINGTON — What does a company do when there's anecdotal evidence that two of its drugs are equally effective in treating a leading cause of blindness in the elderly, one costing patients $60 per treatment and the other $2,000?
In the case of Genentech Inc., nothing.
The company declined to seek federal approval for the cheaper drug, Avastin, to treat the wet form of age-related macular degeneration. Nor would it help finance — or cooperate with — a National Eye Institute study comparing the effectiveness and safety of Avastin, a cancer drug, and the more expensive eye drug, Lucentis.
The financial stakes stemming from the study are huge. Medicare officials estimate there could be 50,000 or more additional cases of macular degeneration a year. Treating just one year's worth of new patients with Lucentis would cost $1.2-billion a year, compared with $60-million if they're treated with Avastin, Medicare officials said.
On the other hand, Genentech spent decades and hundreds of millions developing Lucentis.
Genentech is making no promises that it will act upon drug trials, which are expected in two to three years.
The company has raised concerns that safety issues were not properly addressed. In particular, the trial doesn't have enough patients to show some of the rare but serious side effects that could occur with use of the cheaper drug, the company contends.
"No matter the outcome, we continue to believe Lucentis is the most appropriate treatment for wet AMD," said Krysta Pellegrino, a company spokeswoman.
Many eye doctors believe Avastin works just as well in treating macular degeneration, even though it hasn't been approved for that purpose. It's not unusual for drugs to be used off-label — treating diseases other than ones the drug was approved for.
Companies routinely help finance clinical trials, but such trials almost never pit two products from the same company against each other.
"It's a very unusual situation where a company would be trying to compare its own drugs," said Dr. Frederick Ferris, director of clinical research at the National Eye Institute. "I'm not sure usual situations are all that relevant in this particular case."
As lawmakers await the results of the drug trial, they are already considering what steps, if any, could be taken to steer the Medicare program to the less costly drug — if it's indeed comparable.
An internal memorandum from congressional aides to the Senate Aging Committee's chairman, Herb Kohl, D-Wis., recommends that lawmakers consider urging Medicare officials to pay no more for one drug than the other when it comes to treating the eye disease.
Medicare's contractors already have authority to pay the same amount for items that achieve much the same result — such as hormones used to treat prostate cancer.