Friday, June 18, 2010

Avastin/Lucentis Update 39: And the Controversy Continues

This article was published in yesterday’s Wall Street Journal. It again illustrates how Medicare operates with one hand tied behind its back.

WSJ, June 17, 2010

By Alicia Mundy

Medicare could save more than $500 million annually by using a cheaper Genentech drug to save vision, according to a draft study by federal officials and a University of Miami eye doctor.

The study shows that the cheaper drug, Avastin, is already used in about 65% of Medicare patients with wet age-related macular degeneration and accounts for nearly 60% of their eye injections, compared with about 40% for a more expensive drug called Lucentis. However, Medicare paid $537 million for Lucentis in 2008 and only $20 million for Avastin, according to the unpublished study, which was reviewed by The Wall Street Journal.

The numbers point to a delicate problem for the federal program for the elderly, whose rising costs are often cited as among the biggest long-term factors in the federal budget deficit. Both drugs are made by Genentech, but only Lucentis is approved by the Food and Drug Administration to treat the disease, the leading cause of irreversible blindness among older people.

Clinical trials suggest that Avastin, approved by the FDA to treat some forms of cancer, is also effective in treating the eye disease. Doctors have been "voting for Avastin with their feet," said Philip Rosenfeld, a retina specialist at the University of Miami's Bascom Palmer Eye Institute and one of the study's authors. Some pharmacies take supplies of Avastin and divide it into tiny doses suitable for injection in the eye.

The study, based on data from more than 200,000 Medicare patients, found that Medicare paid on average $42 a dose for Avastin in the eye, compared with $1,593 a dose for Lucentis.

Genentech, part of Roche Holding AG, says Avastin's risks and benefits in eye disease aren't known. It says the high price of Lucentis is justified by the drug's benefits in preventing blindness and the years of research Genentech put into demonstrating efficacy. A Genentech spokeswoman declined to comment on the Medicare study.

Three of the study's four authors are officials at the Centers for Medicare and Medicaid Services, the federal agency that administers Medicare.

Dr. Rosenfeld, the fourth, said the authors completed their work last year but have run into roadblocks getting top officials at the agency to allow them to submit the study to a medical journal and peer review. He charged that the agency was trying to suppress the study to avoid antagonizing Genentech and added, "I'm tired of the delaying tactics."

Medicare's chief medical officer, Barry Straube, denied any effort to hinder release of the data. He said he hadn't realized that the authors viewed the matter as pressing and said, "I think we can speed this up significantly."

Dr. Straube said he had no problem with the data collected by the authors but is waiting for more information from them about how the data can be translated into policy. He said Medicare is prohibited from doing cost-effectiveness analysis.

The purpose of the study, Dr. Rosenfeld said, was to ascertain how many doctors are using Avastin instead of Lucentis, as a measurement of the standard of care for the eye disease. "Doctors want to know if they are treating patients the way other physicians are, and this helps them," he said.

Sen. Herb Kohl, a Wisconsin Democrat who is chairman of the Senate Committee on Aging, criticized the delay in publishing the study. "It is baffling that CMS would delay the release of this data when there are hundreds of millions of taxpayer dollars at stake," he said.

Mr. Kohl said it is "puzzling to me ... that the federal government continues to reimburse Lucentis at 40 times the amount to treat the same conditions."

Dr. Rosenfeld co-authored a key study showing Lucentis's success in slowing down macular degeneration. He pioneered the use of Avastin in the eye in 2005, while awaiting the FDA's approval of Lucentis. A study of 131 patients published last week in the British Medical Journal BMJ said Avastin was safe and effective in treating macular degeneration.

(Editor’s Note: In the small study – only 131 patients, recently published in the British Medical Journal, Avastin was compared to verteporfin PDT, Macugen, and a sham laser treatment for wet AMD. The study was started before Lucentis was approved for use in the UK, and the Avastin was used off-label. I have provided a link to the original article in the BMJ.)

Dr. Rosenfeld said he was now concerned that because of Lucentis's high price to patients-Medicare covers only 80% of the cost-many can't continue treatment and some doctors don't give injections frequently enough to hold off blindness.

Last fall, the federal Medicare center tried to roll back payments to eye doctors using Avastin by more than 80%. The lower rate would have pushed doctors to prescribe more Lucentis, even at higher cost to the federal government.


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