NIH BEGINS COMPARATIVE DRUG TRIAL
The government's effort to compare different drug products is moving forward, with the NIH's National Eye Institute funding a clinical trial comparing two drugs used to treat advanced age-related macular degeneration (AMD), the leading cause of blindness among the elderly.
The trial will compare two Genentech drugs, Lucentis and Avastin, to gauge their effectiveness in treating advanced AMD. The FDA approved Lucentis (ranibizumab) earlier this year to treat AMD, while Avastin (bevacizumab) is widely used off-label to treat the ailment. The study will assess the relative safety and effectiveness of the two drugs.
The study is the latest step in the government's recent push for comparative trials. The FDA, NIH, Centers for Medicare & Medicaid Services (CMS) and HHS' Agency for Healthcare Research and Quality have all proposed comparative studies as a way to discover the most effective treatments.
But at least one of these efforts hit a roadblock recently. The CMS had been planning to share prescription drug plan data with the FDA in an effort to base Medicare reimbursement on product comparisons, but has suspended this effort, an industry source said.
The agency is worried that, while the Medicare Rx Law gives it the authority to use Part D data for payment purposes, it may not be able to use this information to make comparisons between competing drugs. Also, the main proponent of this initiative, CMS Administrator Mark McClellan, is leaving at the end of this week.
Activists are applauding the NIH decision as a step forward toward controlling drug costs. "We have to get a handle on costs, and comparative effectiveness trials are our best hope for identifying and paying for the most effective medicines -- and avoiding or reducing payment for less effective medicines and procedures," Bill Vaughan, senior policy analyst with Consumers Union, said.