Device Makers Cite Special Concerns With Comparative Effectiveness
From the October 29, 2007, issue of "The Gray Sheet"
Comparative effectiveness research, where evidence supporting an established medical therapy is stacked up against that of up-and-coming approaches, is a small but growing element of the U.S. government's strategy for assessing health care.
It is likely to become much more significant in the coming years. There is substantial momentum in Congress to establish a new federal center for prioritizing and conducting comparative effectiveness reviews as a component of Medicare reform (1"The Gray Sheet" Oct. 1, 2007, p. 12). Several presidential candidates have proposed similar measures.
The device industry is viewing these developments with substantial skepticism and is lobbying Capitol Hill accordingly.
Manufacturers are concerned that comparative effectiveness will be used to deny coverage for some of their products, particularly the most expensive and high-tech varieties.
The industry acknowledges the value of getting an overall picture of where the evidence stands - say for a relatively new minimally invasive procedure compared to a drug regimen - but it is warning of dampened innovation and declining health care quality if too much stock is put in the results.
Iterative Development Is Key Issue For Industry
Gail Wilensky, a senior fellow at Project Hope and a former administrator of CMS, who is one of the biggest comparative effectiveness champions in Washington, D.C., says that device industry representatives she has interacted with appear more concerned about the prospects of a new government-funded comparative effectiveness agency than the drug industry.
"My personal observations have been that the device industry is much more mixed in terms of how they are viewing this," she noted Oct. 17 at the ECRI Institute's annual conference in Washington, D.C.
Brian Firth, worldwide VP for health affairs for Johnson & Johnson/Cordis, says there is good reason for this - devices are developed in short-turnaround iterative fashion, whereas individual drugs remains unchanged on the market for a much longer period of time.
"The drug field in a lot of ways is much more stable," Firth explained at the ECRI meeting.
In the device industry, "one of the biggest challenges in this conversation about comparative effectiveness ... is that you are not in a state of equipoise," Firth said. "You're dealing with a state of evolution, and I think there's nervousness about what conclusion will be drawn at what point in time, and whether it will give you correct information."
Firth cited examples in interventional cardiology, where Cordis is a major player. The safety and effectiveness of stents improved dramatically in the first few years after their introduction as the procedure evolved, he said. "So what's the right time to do a comparative evaluation?"
He also pointed out that a technology can become outdated by the time a comparative effectiveness study is complete.
For instance, the National Institutes of Health-sponsored BARI trial enrolled 1,829 patients between 1988 and 1991 to compare balloon angioplasty to bypass surgery. But by the time five-year follow-up from the study was reported, "the results were irrelevant," he said, because stents had come along and no one did simple balloon angioplasty anymore.
"We might not want to spend a huge amount of money on something that is evolving, and where the next device will be out by the time you get an answer on the first one," Firth said.
More recently, the Agency for Healthcare Research and Quality, which receives annual funding of $15 million to conduct comparative effectiveness reviews (a small fraction of the amount being floated to fund a new center), released a report Oct. 15 evaluating 23 trials, including BARI, comparing bypass surgery and angioplasty.
AHRQ found a higher rate of repeat revascularization with angioplasty, but notes that more study results are needed to assess the impact of stents, and drug-eluting stents in particular (2"The Gray Sheet" Oct. 22, 2007, In Brief).
AdvaMed's Comparative Effectiveness Principles
Ultimately, the device industry's biggest concern is that comparative effectiveness research - which reps stress reveals the therapy that is better on average - will be used to deny access of its products to individual patients that might benefit.
"It is crucial in our view to continue to protect the doctor-patient relationship and allow physicians and patients to exercise judgment," AdvaMed President Steve Ubl said Oct. 24.
Ubl says he recognizes there is valuable information that comparative effectiveness reviews can contribute to informing physicians' judgments, but that is where its utility should end. "To take a treatment option off of the table makes little sense," he said.
In lobbying Congress on the issue, AdvaMed has been pushing three main principles: 1) any legislation should explicitly prohibit using comparative effectiveness research to deny individual Medicare coverage; 2) only clinical effectiveness, not cost effectiveness, should be permitted to be considered; and 3) device manufacturers, along with patients, doctors and other stakeholders, should all have a seat at the table in establishing comparative effectiveness policies.
Ubl acknowledges that some members of Congress are "reluctant to tie the hands explicitly on a future outcome of this type of research," but says policymakers are generally receptive to the device industry's concerns.
Insurers Eye Cost Savings From Comparative Data
However the federal government ends up framing the connection between comparative effectiveness and Medicare, private health insurers certainly see an opening to save on costs.
The Blue Cross Blue Shield Association said in May it will step up to pay its fair share to fund an independent comparative effectiveness center if Congress passes a bill (3"The Gray Sheet" May 14, 2007, p. 6).
And during the ECRI meeting, Aetna Chief Medical Officer Troyen Brennan, M.D., stressed the need for better evidence to support coverage and payment decisions.
He cited computed tomographic angiography, used to gather 3D images of heart vessels, as one high-cost area where he thinks comparative data could help.
"Sixty-four-slice CT scanners are basically selling like hot cakes," Brennan said. "And we don't have any good evidence whatsoever about how we should use them." Aetna will not cover CT angiography for screening of asymptomatic patients, patients at intermediate or high pretest probability of coronary artery disease, or evaluation of stent occlusions.
In general, the availability of more comparative effectiveness data will allow insurers such as Aetna to create more subtle and targeted payment strategies, which will make consumers more aware of costs of some medical devices, Brennan said.
Specifically, consumers may have to take responsibility for a bigger share of the cost of expensive devices if the effectiveness data does not show substantial clinical benefit over existing treatments, he said.
These so-called "tiered" models, where the payer covers a portion of the cost depending on how good the evidence is, require mature evidence that may not be available yet for many device interventions.
Under this approach, he suggested that as long as there is some clinical benefit, Aetna would not deny coverage simply because a product is high cost.
"We'll probably let people have access to the technology that they want, but just have them pay more out of pocket for that," he said.
- Chloe Taft and David Filmore
