First published 4/28/11 on Gooz News
I first noted the controversy surrounding the use of Genentech’s Avastin instead of Genentech’s Lucentis for advanced macular degeneration (AMD) in 2006, shortly after the Guardian in the UK broke the story about how ophthalmologists around the world were opting for the cheaper version of what was essentially the same drug. Long story short: Genentech in the early 2000s began selling large vials of Avastin to block the formation of new blood vessels when treating colon and other cancers. Ophthamologists quickly discovered minute injections of Avastin were extremely effective in treating AMD, which involves excess blood vessel formation in the eye. The cost of small injections to break up those blood vessels was about $50 a shot. Genentech then developed a variation of Avastin called Lucentis, ran a clinical trial testing it in AMD patients, got it approved by the Food and Drug Administration, and began charging nearly $2,000 for the shots, which are needed monthly. The co-pays for seniors alone could run into the thousands of dollars a year. The National Institutes of Health, responding to a cost-driven controversy, authorized a clinical trial comparing the two.
Today, the New England Journal of Medicine — a half decade after the controversy erupted — published the results of that trial. Guess what? No difference, something ophthalmologists have known from the start. But they never had ironclad scientific proof. Now they do. As an accompanying editorial in NEJM said, the trial results support use of either bevacizumab (Avastin) or ranibizumab (Lucentis). But Philip Rosenfeld of the University of Miami also noted:
Health care providers and payers worldwide will now have to justify the cost of using ranibizumab (Lucentis). Regulators in certain countries will be forced to reconsider their policies that make it illegal to use drugs off-label, particularly when so many of their citizens cannot afford ranibizumab. The (study) data support the continued global use of intravitreal bevacizumab (Avastin) as an effective, low-cost alternative to ranibizumab.
As I wrote last July, Medicare could save a half billion dollars annually by authorizing payment for off-label use of Avastin for AMD and simultaneously refusing to pay for Lucentis. I’m guessing they will soon start paying for its off-label use, now that they have the NIH study in hand. But as far as using this nifty piece of comparative effectiveness research to deny paying for the expensive alternative, that’s not going to happen. The Affordable Care Act, which earmarked $1 billion a year for CER, specifically forbade the Centers for Medicare and Medicaid Services from using CER to inform any cost-effectiveness analysis that might lead to denial of coverage for economic reasons.
What to do? When Republicans in the House bring up H.R. 1213, which calls for eliminating federal funding for the state-based exchanges needed to implement health care reform, Democrats in the House might want to offer an amendment repealing the cost-effectiveness restrictions on use of studies conducted by the Patient Centered Outcomes Research Institute, which is the body set up to conduct CER. It would be interesting to see how many votes it gets from the crowd that claims privatization is the only way to control Medicare’s costs.
Merrill Goozner is an independent health care journalist. He maintains a blog at Gooz News.