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Understanding how a full-blown effort would affect the marketplace is incredibly complicated, says Jeffrey Lerner, Ph.D., president of ECRI Institute, a nonprofit healthcare research organization that has done comparative effectiveness research for 40 years. “If the health system moved much more toward doing these kinds of comparisons,” he says, “I think there would be a very large effect on how technologies enter the healthcare system.”
Despite widespread agreement that such research is needed, building consensus on specifics will remain difficult, in part because comparative effectiveness results almost always identify “a loser”—or at least a “less effective” procedure, drug, or device. And none of the center’s architects kids themselves that it will be a simple structure to build.
PhRMA’s Burkholder points out that proponents of the research have taken many of their ideas from the United Kingdom’s National Institute for Health and Clinical Excellence (NICE) and a similar program in Australia. Those programs are worrisome to pharmaceutical manufacturers, who argue that NICE has delayed use of innovative treatments for years waiting on cost-effectiveness studies and that it has denied patients medication based on cost-effectiveness.
What’s more, manufacturers have warned Congress that this kind of evidence can be misused as a foundation for one-size-fits-all coverage or payment policies on medications or other treatments. And this at a time when the medical world is showing that one size most certainly does not fit all—from patient experience to research to emerging molecular medicine.
In voicing the special concerns of the manufacturers of medical devices, Edwards LifeSciences’ Mussallem argues that device innovation evolves fairly continuously and that “the effectiveness of a particular product often depends on both the healthcare professional’s training and experience with the product.”
With comparative effectiveness research, however, “you essentially have to stop the music and measure your effectiveness at a point in time,” he says. It’s a process, Mussallem worries, which could cause valuable technology to become unavailable, because it did not test well against another treatment at a particular moment.
Mussallem emphasizes that transparency and input from industry is going to be critical: “Because it is possible for these studies to be misguided and to use the improper time frame or not be focused on the particular specifics of the condition and the disease.”
He calls for a process that not only encourages early input, but also has a review period at the end of the study, allowing for a possible challenge, for example, by industry or by medical societies. He, too, worries that the information might lead to a “one-size-fits-all approach to medicine,” as opposed to a marketplace where there are a number of choices for individual patients.
Speaking at a conference in Washington, D.C., Nancy Davenport-Ennis, head of the National Patient Advocate Foundation, voiced the same types of concerns. “I think the fear of consumers is that they want to have the information around comparative effectiveness, but they do not want an independent third party determining for them what is the most effective protocol to be used,” she said.
Could the marketplace become so unfavorable to a specific treatment, after it was found less effective, that it would never get another chance? Wilensky argues that the research results are not usually going to be so cut-and-dried as to push a treatment completely off the market: “Frequently the issue is how much better, how much worse, for whom? And how strong is that likelihood?” She does note, however, that “there is no guarantee that payers in either the public or private sector won’t misuse information. But, of course, they can do that now.”
ECRI’s Lerner says, “It would be very challenging for manufacturers, because they are trying to get rules that they can understand for both approval of their technologies and then use. And this would create a more fluid situation.” The competitive landscape would be tougher, he says, in part because manufacturers would be trying to guess what their product would have to beat, even while they are still in the early development phase.
But in a forum last February, John Rowe, M.D., who was Aetna’s CEO until last year, said, “I would expect wide adoption of any recommendations that came out of an organization like this in the commercial and the non-for-profit health plans in the United States. Very wide adoption. They are really hungry for this.”
“It’s complex,” Lerner sums up. “I’m in favor of it. And I do think we need to get started, because otherwise we will never evolve the methodologies and the social acceptance…. So I don’t think it’s dangerous to do this. I just think it has to be implemented with thoughtful people who know they are experimenting.”
Kathryn Foxhall is a freelance writer covering health and health policy and is based in Maryland.
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