Roche Drug for Unapproved Use May Save $1 Billion, U.S. Says
Medicare could have saved $1.1 billion in 2008 and 2009 by expanding use of Roche Holding AG (ROG)’s cancer drug Avastin to treat an eye disease, a low-cost option unapproved by U.S. regulators, an audit found.
The U.S. should consider such “off label” uses when reviewing coverage policies for Medicare, the federal health program for the elderly and disabled, the Department of Health and Human Services said in a report today.
Roche, based in Basel, Switzerland, is fighting two Democratic senators’ efforts to expand Avastin’s use for wet age-related macular degeneration, a leading cause of blindness affecting more than 1 million Americans. The company makes a drug, Lucentis, for the condition that’s approved by the Food and Drug Administration and is 40 times more expensive.
Medicare is evaluating its policies and “will seek additional authorities as necessary,” said Marilyn Tavenner, Medicare’s principal deputy administrator, in a July 15 response to the findings included in the report.
The inspector general for HHS found Medicare beneficiaries could have saved $275 million in copayments by using Avastin exclusively rather than Lucentis in 2008 and 2009.
Medicare covers Avastin at a cost of less than $50 a dose compared with $2,000 for each injection of Lucentis, Jonathan Blum, deputy administrator at the agency, said during a Senate Aging Committee hearing.
Senators’ Efforts
Democratic Senators Herb Kohl of Wisconsin and Sherrod Brown of Ohio have pushed the Medicare program to declare Avastin necessary to fight wet age-related macular degeneration.
Medicare can’t take cost into account in making such determinations and doesn’t have to issue the recommendations.
Roche points to studies at Duke University and the Johns Hopkins University based on Medicare claims data that show use of Avastin, approved for colon cancer, for the eye condition increases the risk of stroke and death in seniors. Roche funded the Johns Hopkins study.
The FDA warned Aug. 30 that repackaged Avastin injections caused at least 12 serious eye infections in the Miami area. Some patients were completely blinded as a result.
Five other people taking Avastin were blinded last month at the Veterans Affairs medical center in Los Angeles, the New York Times reported Sept. 2.
Avastin is Roche’s top-selling drug, generating 14 percent of the company’s revenue with global sales of 6.46 billion Swiss francs ($8.03 billion) last year. Lucentis cost $1.1 billion to develop in 11 years. The treatment generated $1.4 billion in sales last year, according to data compiled by Bloomberg.
An FDA advisory panel turned down Avastin’s use in breast cancer in June because the treatment didn’t work as well as the agency expected and can cause deadly bleeding.
To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net.
To contact the editor responsible for this story: Adriel Bettelheim at abettelheim@bloomberg.net.
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