Genentech Inc. has two biological agents that can treat Age related Macular Degeneration (AMD) a leading cause of blindness in the elderly Avastin and Lucentis. The cost of each drug is significantly different and only one is approved by the FDA for that indication. While Avastin can run $60 per patient (off label) which is a significantly reduced does of Avastin used for cancer treatment and Lucentis which was designed specifically for the treatment of AMD costs as much as $2,000 (on label).
As a result, Genentech has come under scrutiny this past year when the company declined to seek federal approval for Avastin for AMD. Some cursory evidence shows that Avastin was similarly effective at treating AMD as Lucentis, according to the Associated Press.
The initial media coverage also indicated that Genentech would not help finance or cooperate with “a National Eye Institute study comparing the effectiveness and safety of Avastin, a cancer drug, and the more expensive eye drug, Lucentis.” The results of this study, which was eventually carried out, are due in 2011.
In their defense of withholding support from the study, Genentech maintained that safety issues were not properly addressed in the study because the trial doesn't have enough patients to show some of the rare but serious side effects that could occur with use of the cheaper drug which was designed to reduce blood flow in larger vessels.
Moreover, to develop Lucentis Genentech spent more than $45,000 per patient, for a clinical trial involving more than 6,000 patients. Since such an effort took decades and hundreds of millions of dollars to develop the drug, it is important that the company is not penalized for promoting Lucentis according to their FDA label.
Consequently, the company’s actions came under review because Medicare officials estimated that there could be 50,000 or more additional cases for the use of these drugs each year. If those predictions were accurate, treating just one year's worth of new patients with Lucentis would cost $1.2 billion a year, compared with $60 million if they're treated with Avastin.
This past week, Senator Herb Kohl (D-WI), Chairman of the Senate Aging Committee, brought up the very same issue according to the Wall Street Journal. In his letter sent to Genentech, Mr. Kohl asked the company whether they played any role in creating such a shift that could prompt eye doctors to use the more expensive drug however, Genentech, which recently became part of Roche, has already asserted they were not involved, according to WSJ.
While the clinical trial testing both of the drugs is still occurring, Mr. Kohl believes that Genentech “may have communicated directly with CMS officials about this change.” Mr. Kohl is concerned about such communication because “a variety of medical authorities and advocates are complaining that the new coding system CMS implemented this month will reduce reimbursements to physicians for Avastin to a small fraction of the previous rate.” (a variety of medical authorities is code for more than one activists) Since this will make it more difficult for physicians to recoup their costs, Mr. Kohl is worried that physicians will be forced to prescribe the more expensive Lucentis to make up for this lack in reimbursement.
The FDA has already informed the Senate Aging Committee that Avastin has roughly the same safety profile as Lucentis for intraocular use. The FDA even encouraged Genentech to seek formal FDA approval based on the “substantial clinical data available documenting its safety and efficacy.”
In the end, Genentech, the FDA, and the Senate should consider waiting for the NIH study to be completed. Just as Genentech spent years to develop the drugs and millions investing in helping save people’s vision.