Sen. Kohl investigates Genentech sales halt

December 15, 2007

As Genentech prepares to stop selling bevacizumab (Avastin) to compounding pharmacies on Jan. 1, retina specialists are watching to see what effect a Senate investigation may have on the drug's availability.

Key Points

Washington, DC-As Genentech prepares to stop selling bevacizumab (Avastin) to compounding pharmacies on Jan. 1, retina specialists are watching to see what effect a Senate investigation may have on the drug's availability.

Sen. Herb Kohl (D-WI), chairman of the Special Committee on Aging, has requested extensive documentation from Genentech regarding its Oct. 11 decision to limit sales of the drug. Sen. Kohl also requested documents from the FDA and the Centers for Medicare and Medicaid Services (CMS). The documentation was due Dec. 7.

Genentech spokeswoman Krysta Pellegrino said the company was working with Sen. Kohl's office to provide the documents.

Jack Mitchell, chief of investigations for the committee, said Dec. 10 he had not received all of the documentation requested.

"I have received some documents; I haven't received full responses yet," Mitchell said. He added that such document requests are "standard procedure" prior to a Senate oversight committee hearing, which Mitchell described as a "fair to strong possibility," although nothing is scheduled yet.

Sen. Kohl's office had asked the FDA to clarify whether it asked Genentech to limit the drug's availability or to destroy four potentially contaminated lots of bevacizumab. It asked CMS how much it had spent on bevacizumab and ranibizumab [Lucentis, Genentech] from 2005 to the present and what measures it had taken to attempt to reduce expenditures through the use of alternative drugs such as bevacizumab.

Retina specialists commonly have used bevacizumab off-label as a lower-priced alternative to the FDA-approved ranibizumab for the treatment of wet age-related macular degeneration (AMD) and other disorders.

Both products have similar dramatic results in halting the progression of wet AMD and in reversing its damage in some cases. Bevacizumab, however, is not approved for ocular use, as is its higher-priced cousin, ranibizumab, which underwent extensive ocular trials prior to approval. Retina specialists alarmed by the shocking price differences between the products often relied on compounding pharmacies, which purchased vials of bevacizumab and divided it for ocular injections. Wholesale prices of the drugs ranged from $1,950 per dose for ranibizumab to $5.50 per dose for bevacizumab, according to Genentech spokeswoman Dawn Kalmar.

Kalmar said the company needed to protect its drug from counterfeiting. She also argued that limiting its sales through compounding pharmacies did not make bevacizumab less available to physicians because it would still be available through hospital pharmacies and distributors. Physicians, however, said that the change leaves them in a lurch since most do not acquire their drugs through hospital pharmacies.

After meeting with representatives from the American Academy of Ophthalmology and the American Society of Retina Specialists, the company agreed Oct. 26 to extend its sales cut-off date from Nov. 30 to Jan. 1.

In his letter to Genentech, Sen. Kohl said he was deeply concerned about the financial impact this distribution change would have on Medicare. According to a Wall Street Journal article, Medicare program administrators estimated the limited sales of bevacizumab could cost taxpayers $1 billion to $3 billion more each year.

"Most troubling about this proposed plan is the fact that it may be due in part to an effort to boost sales of a chemically similar yet far more expensive drug–[ranibizumab]," Sen. Kohl wrote. "While we're aware of your company's public explanations for it, this decision may serve to increase costs for critical ophthalmology medicines for seniors and the elderly, as well as eye-care patients in general."