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Senate probes Genentech's plan to limit sales of bevacizumab
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A U.S. Senate committee is investigating Genentech in regards to its plan to cease supplying the cancer drug bevacizumab to compounding pharmacies that repackage the drug for ophthalmic use. The plan is scheduled to take effect Jan. 1.
On Nov. 28, Sen. Herb Kohl, D-Wis., chairman of the Senate Special Committee on Aging, released letters he had sent to the Centers for Medicare and Medicaid Services' acting administrator Kerry Weems, U.S. Food and Drug Administration Commissioner Andrew von Eschenbach, MD, and Genentech's president of product development Susan Desmond-Hellman, MD, MPH.
Sen. Kohl requested information regarding negotiations between Genentech and government and private sponsors of a large study that will compare the efficacy of Avastin (bevacizumab) to Lucentis (ranibizumab) for treating wet age-related macular degeneration.
Many ophthalmologists prescribe bevacizumab off-label for treating wet AMD. A once-monthly dose of ranibizumab reportedly costs about $2,000, whereas a comparable dose of bevacizumab costs about $40, according to a press release from the senator's committee.
In the letters, Sen. Kohl cited a Wall Street Journal report that attributed the Genentech plan to the company's intention to boost sales of ranibizumab.
"Some physicians have charged that Genentech's intention in limiting Avastin's availability is to boost sales of Lucentis, a chemically similar yet far more expensive drug also produced by Genentech," Sen. Kohl said in the release.
Sen. Kohl cited Genentech's reported refusal to support the upcoming Comparison of Age-Related Macular Degeneration Treatment Trials (CATT) study, which is designed to weigh the safety and efficacy of bevacizumab and ranibizumab in treating AMD. The trial is jointly sponsored by the National Institutes of Health and National Eye Institute.
"We are aware of the request for information Senator Kohl sent to [CMS] on October 18, 2007," Genentech spokesperson Krysta Pellegrino told Ocular Surgery News via e-mail.
"On November 16, 2007, Genentech received a letter request from Sen. Kohl to provide background information related to Genentech's decision to no longer allow compounding pharmacies to purchase Avastin and related communications. The request letter is not a subpoena; rather, it is a voluntary request for information. Genentech intends to cooperate with Sen. Kohl's request for information and work closely with Committee staff to answer their questions," she said.
At the American Academy of Ophthalmology meeting in New Orleans, Dr. Desmond-Hellmann said Genentech will not support the CATT trial because ranibizumab has already been approved as a safe and effective treatment for AMD.
The Wall Street Journal reported that the Genentech plan may cost taxpayers $1 billion to $3 billion annually in higher Medicare spending.
"Any instance that could cost taxpayers potentially $1 billion to $3 billion is of great concern to me," Sen. Kohl said in the letters. "I take very seriously the [Aging] Committee's responsibility to protect and advocate on behalf of our nation's seniors. Part of this responsibility is ensuring that seniors are receiving appropriate and cost-effective prescription drugs."
Sen. Kohl is drafting legislation that would let CMS waive co-payments for patients participating in government-funded clinical trials and comparative-effectiveness studies, according to the release.