NIH Study: Save Your Eyesight AND $10,000/year

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NIH Study: Save Your Eyesight AND $10,000/year

Postby jimithy » Tue May 03, 2011 9:00 am

Wall Street Journal Article:

Study Compares Lucentis, Avastin

Both sides in a debate over eye treatment took solace from a study that said Genentech drugs Lucentis and Avastin are equally effective in the eye but Avastin had a slightly higher rate of serious events.

Avastin isn't approved to treat age-related macular degeneration, the leading cause of blindness, but many doctors use it anyway because it costs only about $50 a dose compared with $2,000 a dose for Lucentis.

In addition to comparing the two drugs, the closely watched federal study also suggested that Lucentis could be used less frequently than the monthly dose that is standard now, potentially chopping nearly $10,000 off the annual cost.

Genentech, a unit of Roche Holding AG, has argued that it is risky to prescribe Avastin, which is approved as a cancer treatment, for an unapproved use. The company said the new results from the National Eye Institute, part of the National Institutes of Health, buttress its case.

Anthony Adamis, Genentech's global head of ophthalmology, said Lucentis beat Avastin in its ability to completely eliminate excess fluid build-up in the eyes of some patients. He said Lucentis is designed to clear the body within hours rather than days for Avastin, and pointed to the slight safety difference observed in the NIH study.

"It bears out what we've been saying. Lucentis is designed for the eye and Avastin is designed for cancer," Dr. Adamis said.

Doctors who have been prescribing Avastin for the eye condition said the study, which was published in the New England Journal of Medicine, backs their case that Avastin is a viable option given the wide difference in cost.

"Health-care providers and payors worldwide will now have to justify the cost of using" Lucentis, wrote Philip Rosenfeld, a retina specialist at the University of Miami, in an accompanying editorial in the New England Journal.

The study's lead author, Daniel Martin of the Cleveland Clinic, said Avastin is the most commonly used drug for age-related macular degeneration in the U.S., and he said the study finally provides clinical data to support that choice.

Dr. Martin said "the two drugs were virtually identical" in terms of effectiveness measured one year after starting treatment. He said the second year's data will be released next year.

The study, which involved about 1,200 patients, also found no difference in death, heart attacks or strokes. The study showed serious adverse events, most of which were hospitalizations, occurred at a 24% rate for patients receiving Avastin and a 19% rate for patients receiving Lucentis. The average age of patients in the study was more than 80 years old.

It's not clear if the drugs played a role in the adverse events. Many of the adverse events involved infections and other problems that weren't previously identified as possible side effects of the drugs, and researchers said the difference might be due to chance. They said a larger study would be needed to determine whether Avastin carried higher risk.

Lucentis had about $1.6 billion in U.S. sales last year. Roche's Genentech unit markets the drug in the U.S., while Novartis AG markets it outside the U.S. Last year, Novartis had Lucentis sales of $1.53 billion, up 24% from 2009.

Trevor Mundel, global head of drug development at Novartis, said the new study had limitations. He called the study's "visual acuity" measurement – which showed little difference between the drugs -- a "pretty crude measure" of efficacy.

Mr. Mundel and Genentech also pointed to a separate study, funded by Genentech, that examined the records of 78,000 Medicare patients who had taken Avastin or Lucentis for AMD.

According to an abstract of that study released earlier this month, people taking Avastin had an 11% higher risk of overall mortality and higher risk of hemorrhagic stroke. The abstract didn't discuss confounding factors such as smoking or age that might have made the Avastin group more susceptible to disease.

The NIH study said many patients could be effectively treated with Lucentis by taking the drug on an "as-needed" basis rather than every month. That could result in savings of nearly $10,000 a year, researchers said, as patients could get four or five fewer injections per year.

In Europe, more patients are starting to use Lucentis on an as-needed basis, which is cheaper for health-care systems and easier for patients, said Mr. Mundel of Novartis.

Some European countries have also capped the amount they are willing to spend on Lucentis. The U.K., for example, pays for 14 doses and then requires Novartis to provide free any additional doses the patient may need.

The U.K.'s national health service is conducting a trial similar to the NIH study. Results of the U.K. trial, which is comparing Avastin to Lucentis in about 600 patients, are expected later this year. ... lenews_wsj
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