Leading off the Presidential Symposium at the 52nd ASTRO Annual Meeting, ASTRO President-Elect Michael L. Steinberg, MD, of David Geffen School of Medicine at UCLA, gave a presentation titled "How Do Technologies Emerge and How Are They Reimbursed?"

Dr. Steinberg set the table for his lecture with a few facts about the U.S. health-care system. "It's probably no surprise to this audience that the United States spends twice as much on health care as other developed countries, and our expenditures are quickly approaching 20% of our national gross domestic product. On top of that, the number of uninsured Americans continues to rise."

Dr. Steinberg ran down a list of "the usual suspects" in the blame game of rising health-care costs: bureaucratic inefficiencies, defensive medicine, perverse fee-for-service incentives, our aging population, and fraud and abuse.  He pointed out that cost-control strategies and financing mechanisms such as Medicare's sustainable growth rate (SGR) have not worked because they have not addressed a problem that is further upstream.

"The real culprit in unsustainable costs is the rapid and uncontrolled demand for the introduction of new treatments before their effectiveness, cost, and comparative value are satisfactorily evaluated," Dr. Steinberg commented. According to Dr. Steinberg, health economic studies have shown that technology is the major contributing factor in the health-care budget explosion, with 40% to 60% of rising costs attributable to the introduction of new technologies.

Reform and Comparative Effectiveness Research

The Affordable Care Act of 2010 attempts, at least theoretically, to address the issue of rising costs from the evidence and value side. "The Obama Administration demanded reforms to make care more affordable for all U.S. citizens and demanded that we introduce methodologies to compare payment systems, delivery systems, and disease management approaches. Enter a new era of comparative effectiveness research," Dr. Steinberg explained.

Comparative effectiveness research is currently experiencing growing pains, due in part because it is a difficult-to-explain concept that opponents unfairly but effectively link to rationing of care. Nevertheless, the concept of evidence-based value is rooted into the policy of health care and will undoubtedly affect the way cancer care is delivered. Dr. Steinberg said that comparative effectiveness research utilizes systematic evidence review of prospective trials and observational data such as registries and then applies decision analysis and cost-effectiveness analysis to make its determinations.

Comparative Effectiveness Research and Coverage

As an example of comparative effectiveness research in action, Dr. Steinberg used recent data from the Institute for Clinical and Economic Review (ICER), a Boston-based comparative effectiveness research facility. "Researchers at ICER take and consider net health and comparative value and then they evaluate the confidence in the information that they have to ensure that it's valid. Using this methodology, researchers looked at proton-beam therapy vs brachytherapy in the treatment of prostate cancer," Dr. Steinberg commented.

ICER researchers found that although the clinical outcome was similar between both therapies, the cost was significantly higher in proton-beam therapy. So, what does this information mean in the crucial issue of how comparative effectiveness research can be used to address coverage questions, which in turn affect the practice of oncology? "Possibly, with this information an insurance company would cover brachytherapy, maybe allow IMRT with a copayment, and proton therapy might be noncovered or relegated to reference pricing, which relates to participation and trial," Dr. Steinberg said.

The Political Reality

"A centerpiece of the Affordable Care Act (ACA) is the Patient-Centered Outcomes Research Institute (PCORI), which is basically a comparative effectiveness research institute. But interestingly, ACA prohibits the PCORI or HHS from mandating coverage based on its findings," Dr. Steinberg said. After clarifying some of the other seemingly contradictory aspects of ACA's cost-control proposals, Dr. Steinberg noted that the various comparative effectiveness research and evidence-based coverage determination vehicles are still theoretical pieces of the government's reform initiative. Nevertheless, he said, major change is on the way, and oncology is in its crosshairs.

Dr. Steinberg offered a succinct reason for oncology's high profile in health-care reform. "Inflation-adjusted direct medical spending attributed to oncology has shown a 50% higher growth compared with the rest of health care over the past 20 years. If you feel you're a target now, it is only going to get worse," Dr. Steinberg stressed.

But applying evidence and value to treatment and coverage decisions is not a zero-sum game. "The case in point for radiation oncology is intensity-modulated radiotherapy (IMRT), a salient example of rapid increase in utilization and cost to the system, spending more than $1 billion per year in Medicare reimbursement alone, for that single CPT code," said Dr. Steinberg.

According to Dr. Steinberg, the uncontrolled increase in IMRT services was fueled by high reimbursement rates as well as clinician, vendor, and patient enthusiasm about the possible benefits of IMRT over other prostate cancer therapies. "When insurance companies tried to curb the dramatic rise in utilization and cost, we made the 'sharper knife' argument, but it was not accepted because physical differences of dose distribution are not health outcomes," he added.

The bottom line: "There was little evidence developed to support the widespread use of IMRT-certainly not level 1 evidence," Dr. Steinberg said. Then he paused and added, "Now, our elephant in the room is proton-beam therapy."

Conclusion

Dr. Steinberg defined the problem for radiation oncology moving forward: "The process of incorporating new technology into routine patient care, which is already complicated, will become even more challenging as increasing pressure for cost control mechanisms will demand higher levels of proof of cost-effectiveness."

He offered a proposal: "Coverage should be linked to data collection for new technologies and vendors, and payers and providers should participate in and support evidence development. We should build on the concept of 'potential' medical benefit-in other words, adequate initial evidence of benefit and value developed from appropriately designed early trials or prospective registries. And last, payors should cover promising, important, potentially high-value new treatments in the context of very careful investigation." ■