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PERSPECTIVECan A Center For Comparative Effectiveness Information Succeed? Perspectives From A Health Care Company
Comparative information about different approaches to treating a disease or condition plays a critical role in the success of any competitive, market-based health care system in achieving quality and value. To ensure that effectiveness studies will be used to stimulate development of important advances in care and not lead to limits in coverage and treatment options, a comparative effectiveness center needs to demonstrate independence from payers; operate with transparent processes; and coordinate, not duplicate, the requirements of the relevant federal agencies. A fully independent, quasi-governmental center is most likely to produce credible, broadly acceptable findings.
DEMAND IS INCREASING for studies that compare the effectiveness of different treatments for the same condition. The Internet has made consumers accustomed to quick information seeking and comparison shopping in all aspects of life, including health care. In addition to wanting information to address their personal health issues, consumers are interested because many are bearing an increasingly larger share of the cost of care.1 The case for comparative studies. Properly developed and applied, comparative effectiveness information can help establish the value of medicines, procedures, and services and promote a more quality-focused, cost-effective health care system. This information can help physicians, nurses, and other providers make more-informed decisions and support patients’ access to appropriate technologies. Developers of innovative products and procedures see comparative studies as one way to differentiate their products. If comparative studies lead to more streamlined approvals and premium reimbursements for clinically meaningful improvements, research investment will increase in those areas. In her paper, Gail Wilensky notes that proponents of a market-based system and proponents of administered pricing agree on the desirability of comparative effectiveness studies.2 For those concerned about government-administered pricing, the best antidote is a successful market-based system that provides information to make good clinical choices. Reasons for caution. Despite these positives, having better comparative information about therapeutic options will not address some of the major drivers of cost, such as the aging population and growing prevalence of chronic disease. Because comparative studies are also unlikely to produce "clean" answers (definitively good versus bad treatments), coverage policies need to reflect this inherent uncertainty and allow for individual patient variation. One concern that companies such as Johnson and Johnson have is that these studies could be used to limit treatment options rather than to help target the right treatments to the right patients. Instead, comparative studies might be most useful in informing those options and assigning appropriate reimbursement premiums. These studies will also need to accommodate innovations in "personalized medicine." Effectiveness assessments generally describe "average" population effects and often cannot capture individual differences such as side effects, intolerance, non-compliance, and clinical effectiveness. As Wilensky points out, even though most comparative effectiveness studies have focused on prescription drugs, increasing attention is being paid to evaluating medical procedures. In doing so, methods used in these studies will need to consider unique features—the role and training of the operator, impact of procedure volume, ease of use, and shorter product life cycles—that could explain differences in effectiveness and pose challenges to the accurate interpretation of results. Comparative information may be incomplete, misleading, or misinterpreted. For example, the recently published Clinical Anti-psychotic Trials in Intervention Effectiveness (CATIE) study compared the medication-switching rate for several antipsychotics and found that in general, newer medicines did not improve the length of time patients stayed on therapy.3 It led to overly narrow conclusions by some media and payers that such treatments do not have potential to offer a clinically important improvement over older drugs, but it lacked a more detailed assessment of the therapeutic context, including doses, side-effect profiles, and individual patient history. This study illustrates both the promise of comparative research and the perils of incomplete understanding of the research results. Recognizing the risks inherent in overly simplistic conclusions, perhaps comparative studies like CATIE will be found to be most useful in suggesting areas of research regarding the "personalization" of therapy—for example, variations in genetic markers that could lead to better targeting of therapies.4 Whichever entity leads the effort to increase the profile of comparative effectiveness studies, stakeholders need to have an opportunity to participate in framing the methods that will be used and priority therapeutic areas identified for these studies. To succeed, any effort to promote greater oversight by an entity in this area must be accompanied by transparency about the processes, findings, limitations, and appropriate uses of the information. The principles espoused to ensure reasonable processes for coverage decisions—namely, transparency, public accountability, stakeholder input, and appeals mechanisms—might also be applicable for conducting a comparative effectiveness enterprise.5 We need to put in perspective the role of comparative studies in payer coverage decisions, patient-physician shared decision making, and changing incentives in the system (such as "pay-for-performance"). On the one hand, some might want to use comparative studies to limit coverage to the "winner" in a study or as a reason to deny coverage until a head-to-head study is done. On the other hand, an approach more likely to stimulate comparative studies is if they are a condition of coverage to accelerate access to promising new therapies, allowing physicians and payers to gather more data. Comparative studies can also provide valuable information to help patients better understand the risks and benefits of different options and participate meaningfully in their treatment. Outcomes data from comparative studies can be useful in pay-for-performance, as long as they allow physicians to consider variability in patients’ needs. Structure matters. As Wilensky points out, there are several options for structuring an entity that provides independent assessments of comparative effectiveness of alternative treatments for use by payers and makes supporting information available to both patients and providers. We agree that there should be linkage between AHRQ and this new entity and that AHRQ’s critical role in sponsoring health services research should be maintained. Any new center should have certain attributes, in our view. Seek broad participation from stakeholders. The National Institute for Health and Clinical Excellence (NICE) in the United Kingdom is a good example in this regard, including manufacturers, patients, physician, and hospital representatives on its appraisal and review committees.6 Operate under transparent processes and methods while still respecting commercial confidentiality. As described above, the credibility and acceptance of the center’s findings will depend on broad acceptance of the validity of methods and the openness and fairness of the processes used. Limitations and appropriate use of findings must be clear. Demonstrate independence from payers. The center will fail if it is perceived as serving the cost containment concerns of payers as its principal mission. Coordinate, not duplicate, requirements of federal agencies. A new center could add cost and duplication in study requirements without coordination with existing authorities, such as the Centers for Medicare and Medicaid Services (CMS) and Food and Drug Administration (FDA). Some effort should be made to have data collected in one context to be useful in others. Conduct work in a timely fashion. Resources should be adequate to ensure that studies are conducted efficiently and with deliberate speed. A fully independent, quasi-government center is more likely to meet the attributes listed above and to produce credible, broadly acceptable findings than one more closely tied to government. Concluding comments. Consumers, health care practitioners, and payers are interested in having more comparative information so that better choices can be made about treating conditions. Such information plays a critical part in the success of any competitive, market-based health care system. But comparative studies will have limitations that need to be clearly understood and communicated. A comparative effectiveness center can build a framework for sound methods and open processes that will increase the chances that these studies will stimulate the development of important advances in care and not lead to limits in coverage and treatment options.
Kathy Buto (kbuto{at}corus.jnj.com) is vice president, health policy, at Johnson and Johnson in Washington, D.C. Peter Juhn is executive director, health policy and evidence-based medicine, at Johnson and Johnson in New Brunswick, New Jersey. Kathy Buto is a member of the AcademyHealth board. Peter Juhn is a member of the Stakeholder Group for AHRQ’s Effective Health Care program; see http://effectivehealthcare.ahrq.gov/aboutUs/stakeholder.cfm. Johnson and Johnson is a member of the IOM Roundtable on Evidence-based Medicine. The opinions expressed in the paper are those of the authors and do not represent those of AcademyHealth.
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