Sizing Up Comparative EffectivenessSizing Up Comparative Effectiveness

FROM THE EDITORS

The recently passed economic-stimulus bill includes $1.1 billion for comparative effectiveness initiatives. Rising healthcare costs made the advent of comparative effectiveness inevitable. It certainly could be a useful tool for reining in spiraling costs. But its implementation must be watched carefully. The question on everyone's mind is how will such data be used?

The medical device industry is without a doubt in favor of the concept of comparative effectiveness. Stephen Ubl, president and CEO of AdvaMed, has said that the industry organization supports comparative effectiveness research as a way to provide more information to patients and physicians about which treatments are most appropriate for an individual's unique medical needs.
AdvaMed, for example, proposed a series of principles in October that emphasized that such data should not take the place of doctor-patient counseling, and should not in and of itself be used to eliminate treatment options.
And leaders of some of the biggest medical device companies expressed support for comparative effectiveness to Congress in February. Their support, however, assumes that policies won't compromise patients. “Cheapest in the short run is not necessarily the best value for patients over the long term,” Bill Hawkins, chairman and CEO of Medtronic, said according to CNN. “We can't afford a cheapest-at-best approach to medicine,” said Hawkins.
The bill puts the device industry in a bit of an awkward position. The industry has been portrayed as opposing comparative effectiveness, but Hawkins and others have said that it's not the idea of comparing which medical devices work best for specific conditions that's the problem, but rather how the information is interpreted that matters.
I suspect that many seniors are concerned that such a major shift in healthcare policy would be inserted into a stimulus bill with little discussion or debate. The idea that only drugs or devices that work best for most people should be the only ones prescribed is much like saying that women's shoes should only be sold in sizes 7–10; if you need a size 6 or 11, that's too bad because those sizes don't fit the majority of women.
The 15-member Federal Coordinating Council for Comparative Effectiveness Research will be tasked with the job of evaluating treatments. But, can this be done without slipping into a comparison of cost-effectiveness? Much of the onus will fall to manufacturers to ensure that devices are compared based on their clinical effectiveness and value to the patient.
You should also think about what this means for you as a company. Do you have a product—or better yet, products—that can withstand the scrutiny? Maybe your device is the equivalent of the size 6 shoe. And perhaps it costs more than the size 8. With those two strikes against it, you need a strategy for getting your message out to patients, clinicians, and the council.
It is incumbent on the industry to make sure that comparative effectiveness does not stifle innovation. Comparative effectiveness often parallels the idea of evidence-based medicine. Make sure you have done the studies necessary to back up your claims.
“We must guard against an innovation blind spot,” Ubl told CNN. He said that if comparative-effectiveness research is based on cost decisions, it could “put an arbitrary dollar amount on an extra year of life.”
Identifying whether your products are superior to existing treatment options should already be part of your path to market. The new twist will be to determine whether they are sufficiently superior in terms of clinical effectiveness and, yes, cost. The era of comparative effectiveness makes this assessment more critical than ever. Moreover, making sure that you have a deep and diversified product line will be essential to survival.
At the end of the day, if your product can't rise to the top, it may affect your company's ability to survive at all.

Sherrie Conroy for the Editors