Comparative Research Poses Challenges - Pharmaceutical Technology

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Comparative Research Poses Challenges
A new center may provide evidence for improving care, but could discourage coverage of treatments.

Pharmaceutical Technology
pp. 32-40

Modest savings

Whether more comparative research will limit healthcare spending remains to be seen. The Congressional Budget Office estimated earlier this year that the CER initiative will reduce federal healthcare spending by some $3 billion over 10 years—just about what the government will spend on PCORI. And that calculation assumes that comparative studies will lead to changes in physician practice and patient choice. "It's one thing to measure effectiveness; it's a totally different thing for clinicians to have access to the information and use it," pointed out consultant David Axene at the CER Summit. Under PCORI, AHRQ will continue to lead efforts to disseminate CER research findings through guides for clinicians and consumers, along with research reviews and reports.

Potential savings from CER are further limited by Congress' stipulation that Medicare cannot use study results to establish cost-effectiveness thresholds, set practice guidelines, or make coverage or payment recommendations (i.e., PCORI should not become another NICE). However, private insurers and payers are free to tap CER evidence in their coverage decisions, as they have done for years. More outcomes studies will support efforts by payers to negotiate lower rates and steer consumers to more high-value care options.

Consequently, some analysts believe that CER studies should consider cost and pricing issues. At a briefing last month sponsored by the journal, Health Affairs , Harold Sox of Dartmouth Medical School recommends that CER studies include data on utilization and costs so that payers and the public can kno what they're paying for. And Harvard researcher Steven Pearson made the radical proposal that Medicare reward innovation by paying higher prices for products that can document superiority, but only a comparable or "reference" price for those demonstrating comparable clinical effectiveness; new products that fall in the middle would have three years after FDA approval to collect data supporting a premium price.

At the same time, efforts to limit or curtail treatment choices will remain difficult and require a very high threshold of evidence. "CER is not a panacea or a silver bullet," stated Kavita Patel, director of health policy at the New American Foundation, an independent research and poligy organization. Establishing PCORI is "a good first step" toward identifying ways to allocate resources more wisely, she says, but is wary of using CER primarily as a cost-cutting tool. She and others have advised the PCORI board to select a few studies that can move forward on a relatively short schedule so that the program will produce visible results within a year.

Jill Wechsler is Pharmaceutical Technology's Washington editor, 7715 Rocton Ave., Chevy Chase, MD 20815, tel. 301.656.4634,


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