FEATURE: Should comparative-effectiveness research consider cost?

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As healthcare costs continue to skyrocket in the U.S., comparative-effectiveness research has the potential to rein in expenditures by generating evidence that shows how different treatments or drugs compare against each other, in the hope to determine the most beneficial treatment for patients.

However, ever since the economic stimulus package earmarked $1.1 billion in grant monies for comparative-effectiveness research, payors, industry and government stakeholders have taken sides, speculating whether the findings from such government-subsidized research could influence which products or treatments the insurers reimburse and how much they will pay.

In light of these concerns, many argue that cost considerations should be taken out of the comparative-effectiveness research equation altogether. However, John E. Brush, Jr., MD, assistant professor of clinical internal medicine at Eastern Virginia Medical School in Norfolk, told Cardiovascular Business News that costs cannot be ignored when comparing the effectiveness of competing treatments -- it just cannot be the primary factor in determining effectiveness.

In early March, the National Institutes of Health (NIH) began soliciting grant applications to conduct head-to-head studies to determine the best drugs, devices and procedures on the basis of cost and overall effectiveness. Within cardiology, research money is available in areas focused on atrial fibrillation, antiplatelet therapy post-PCI, cardiac biomarkers and cell-based therapies for cardiovascular and blood diseases. Comparative-effectiveness research in these areas could attempt to compare competing drugs, such as Crestor or Lipitor, or it may analyze very different approaches, such as CABG or PCI versus drug therapy, focusing on the medical benefits and risks or weighing the costs and the benefits.

Drug makers have vouched their support of comparative-effectiveness research, as long as it does not limit treatment options. Yet that is what many fear -- that the government-funded research will lead to rationing or restricting of care. This fear is made more real when cost is suggested as being used as a factor in determining which medical treatments are more effective on a given patient population.

The government has attempted to alleviate such concern by appointing a council to hear public comment on how the costs of various treatments could affect healthcare and coverage decisions. Additionally, Senate Finance Committee Chairman Max Baucus, D-Mont., introduced legislation June 9 that would establish a private, nonprofit corporation -- the Patient-Centered Outcomes Research Institute -- to establish a national agenda of research priorities based on the need for better evidence, disease burden, practice variations, the potential for improved care and expenditures associated with a given health condition or care strategy. The institute would have regular reviews by the Government Accountability Office to ensure accountability.

"It just seems so obvious that this is something that is necessary," Brush said. "While cost-effectiveness research is difficult, and the results are not usually definitive, it adds value to the fund of knowledge--and I don't think that is something that should be ignored when looking at comparative-effectiveness research."

Brush says that if cost considerations are used in determining comparative effectiveness, it should be a two-stage process. The first stage should relate to clinical effectiveness, the second to costs.

"If two things are of equal effectiveness, then a direct cost comparison is straightforward," he said. Where it gets a little complicated is when two things have different effectiveness and cost. "Then you have to quantify the difference and put a price tag on it--this is where it gets tricky.

"Because we don't have a national budget or centralized system here [in the U.S.], there is no reason to think that we will suddenly use comparative effectiveness to ration care," said Brush, who did note that the research could be used to determine what the minimum bundle of care might be when considering how to expand coverage to the uninsured and underinsured. "How do you figure what goes in the basic benefit package? You have to do some comparative-effectiveness research."

He adds that if it does lead to some degree of rationing, it would be better than "the current system of cutting off coverage simply because people don't qualify for employment-based insurance