--CONSULTATION REPORT-- HARVARD PILGRIM HEALTH CARE ETHICS ADVISORY GROUP May 15, 2008

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1 --CONSULTATION REPORT-- HARVARD PILGRIM HEALTH CARE ETHICS ADVISORY GROUP May 15, 2008 Developing a Framework of Values for Health Plan Use of Comparative Clinical & Cost-Effectiveness Data Background A growing national bandwagon is calling for more clinical and cost-effectiveness information in health care. In January, 2007, the Commonwealth Fund Commission on a High Performance Health System report on Slowing the Growth of U.S. Health Care Expenditures: What are the Options? emphasized comparative effectiveness information as a central strategy. One year later, in January, 2008, a distinguished Institute of Medicine panel issued an important report - Knowing What Works in Health Care: A Roadmap for the Nation. That report concludes: There is an urgent need for action to change how the nation marshals clinical evidence and applies it to identify the most effective clinical interventions. The nation must significantly expand its capacity to use scientific evidence to know what works in health care. This report recommends that Congress direct the U.S. Department of Health and Human Services to designate an entity either a public or a public-private organization with the authority, expertise, and funding necessary to set priorities for evaluating clinical services, to conduct systematic reviews of the evidence available on these priorities, and to promote the development and use of standards-based clinical practice guidelines. What the IOM proposes, however, would only get us part way towards what we need to achieve cost control as well as improved quality. In order for individuals or health plans to decide on the best use of the available resources, we need information about cost effectiveness as well as the clinical effectiveness information the IOM calls for. Developing sound information about comparative clinical and cost effectiveness is a challenging technical task. But once that information is available we will face a new challenge using it! As individuals we make decisions about what we value more and less all the time. But in health care we have much less experience making these decisions for populations, such as for the membership of a health plan or the population of a state. Steve Pearson, who was formerly a full time faculty member in the Department of Ambulatory Care and Prevention, and a frequent participant in EAG meetings, has founded (in 2006) a new organization the Institute for Clinical and Economic Review (ICER). Steve was a guest and presenter at the May 15 th EAG meeting. He has described the mission for ICER as follows: 1

2 The mission of the Institute for Clinical and Economic Review is to be the most trusted source of information to help fill this evidence gap [for clinical and cost effectiveness] for the benefit of all stakeholders in health and the health care system. Launched in 2006, ICER is an academic technology assessment initiative based at Harvard Medical School. ICER produces rigorous assessments of new medical interventions and translates its findings into integrated ratings specifically formatted to support value-based insurance benefit designs, coverage and reimbursement policy, and patient-clinician decision support tools. Customer: Carolyn Langer, Medical Director for Medical Management and Policy (sponsor); Steve Pearson, Director, Institute for Clinical and Economic Review, and Senior Lecturer, Department of Ambulatory Care and Prevention, (presenter). Questions for the Ethics Advisory Group When individuals go to Consumer Reports to gather comparative assessments before purchasing a car or a new gadget, the values that determine the costs and benefits of the alternatives are their own. But for a health plan to apply comparative effectiveness information, the situation is vastly more complex. The values of multiple stakeholders patients, purchasers, providers, and the wider public (all of whom have voices on the EAG) must all be considered. At the May 15 th meeting, Steve Pearson used his experience in developing the ICER program as an opportunity to help the EAG understand the nature of comparative and cost effectiveness analysis and the kinds of information that will become available to health plans. The task of the EAG was to help Harvard Pilgrim begin to deliberate about the ethical dimensions of how to use that information: What are the key values a health plan should consider with regard to using information about the comparative clinical and cost effectiveness of health care interventions? Relevant precedents The EAG has focused twice on ethical issues associated with judgments of clinical effectiveness on November 15, 2001 ( The Ethics of Last-Chance Therapies: Liver Transplantation for HIV-Positive Patients ) and November 9, 2005 ( Developing a Framework of Values for Determining when Interventions are Experimental or Unproven ). The final point in the summary from the 2005 session identified cost effectiveness as a topic the EAG would need to come back to in the future: 1. The EAG emphasized that making decision about coverage for new technologies requires a prior decision about the standards for good enough evidence. Consistent with the discussion on November 15, 2001 the EAG again strongly endorsed the high standard put forward in the Benefit Handbook as consistent with the mission of improv[ing] the health of the people we serve and the historical medical ethics teaching first, do no harm. 2

3 2. The EAG strongly supported the technology unit s practice of seeking outside expertise as from the Blue Cross/Blue Shield Technology Evaluation Center, Hayes and independent consultants as (a) a crucial supplement to the capacity of the small technology group at HPHC and (b) an antidote to the fear that an insurer s internal decision making process might have a vested interest in coming to negative coverage decisions. 3. The EAG supported the principle that health plans should consider where providers are on the experience curve in making coverage decisions about new technologies as a way of promoting quality of care and protecting patient safety. 4. When emergency circumstances preclude doing a full technology assessment of a proposed intervention in life threatening circumstances the EAG supported the practice of giving the member the benefit of the doubt in gray zone determinations as long as the emergency decision is not seen as a binding precedent for the future. 5. The issue of developing a values framework for health plan decisions about when new technologies do and do not produce enough benefit to justify the cost is likely to be important in the future. The EAG will be happy to address this issue when the time is right. (emphasis added) With the advent of programs like ICER the time is right for the topic that was addressed at the May 15 th meeting! EAG DISCUSSION/RECOMMENDATIONS At the start of the meeting Jim Sabin introduced two guests - Wendy Everett, President of the New England Healthcare Institute, and Rob Mechanic, Director of the Health Industry Forum at Brandeis University. Jim invited Wendy and Rob to be regular participants at the EAG insofar as their busy schedules allow. Steve Pearson launched the discussion with a superb presentation on Ethics and the Use of Evidence to Improve Value in Health Care (circulated with this report). Steve s key points included: Comparative effectiveness is a hot topic in Washington now, with several legislative proposals being developed. The comparative effectiveness (CE) information that ICER is developing will be disseminated to patients, clinicians, insurers and the wider public via a public website. Steve used ICER s comparison of two treatments for prostate cancer (circulated with this report and available via this link) IMRT (Intensity Modulated Radiation Therapy) and 3d-CRT (Three Dimensional Conformal Radiation Therapy) to demonstrate ICER s methodology and rating system. The vertical axis ranks comparative clinical effectiveness; the horizontal axis ranks comparative value. Aa = superior effectiveness and high value. Cc = comparable effectiveness and low value. ICER s CE information could be used in value-based insurance design (for additional background, I have circulated Michael Chernew s testimony about value-based 3

4 insurance to the House Ways and Means Committee with this report). And, Washington State has used ICER s review of CT Colonography in making its coverage decision. I have organized the vigorous and wide-ranging discussion under three headings: 1. Refining comparative effectiveness information to enhance its usefulness and uptake. A participant asked Steve Pearson how ICER can deal with the fact that technologies evolve over time, both with regard to effectiveness and cost. An assessment at one point in time might be inaccurate in 1-2 years. In response, Steve emphasized that CE assessments are best done when a technology is ripe. Timing is determined by polling key stakeholders clinicians, technical experts, payers and advocates. ICER creates analytic tables, and new values can be inserted as new facts emerge about effectiveness and cost. Several participants were concerned that while a technology might provide little or no value for most patients, their might be subgroups who would receive great value. Steve agreed and described how in doing the analysis of IMRT the team looked for the sweet spot for the technology. At the current Medicare reimbursement rate ($42,450) it costs $313,000 to prevent a single case of proctitis (the major complication of 3D-CRT) and $706,000 per Quality Adjusted Life Year (QALY). But for patients at substantially higher risk for proctitis the cost per QALY drops to $117,000. And, for all patients, if the cost for IMRT dropped to $16,900, the cost per QALY dropped to $100,000. A participant noted that while the examples Steve had given were all for new technologies, we know from Wennberg s studies that there is tremendous variation in the use of older treatments. What about developing CE information about treatments already in wide use but uncertain in their relative effectiveness? We might find that some sacred cows are not so sacred after all! Steve agreed that producing CE information on selected established techniques is important. As a practical matter, he envisioned the possibility of moving from unrestricted coverage of a questionable established treatment to covering it in the context of gathering data on its effectiveness. 2. Using comparative effectiveness information fairly. The EAG supported the overall idea of using incentives to promote use of high value treatments, but was concerned about making sure that CE information would be used in a fair manner. Blunt incentives such as substantial coinsurance for treatments that are of low value for most but may be of very high value to a subgroup could make it impossible for lower income insurees to access the treatment. Whereas the EAG felt it was fair to ask people to pay more for low value, optional services, making high value, necessary services difficult to access was seen as unfair and unwise. Several participants mentioned the positive national and local experience with tiered drug formularies. Tiered formularies have succeeded in moving market share to higher value drugs such as generic versions of branded products and less costly members of a group of drugs of comparable effectiveness. Physicians appreciate being able to advise their patients about the relative value of the choices open to them and not being put in the role 4

5 of gatekeeper. Tiered formularies have reduced the cost trend without impeding access to effective treatment. In principle, tiers could be used in a similar way in relation to the comparable effectiveness of other aspects of medical care besides pharmaceuticals in ways that could influence choice without creating excessive barriers. 3. Encouraging stakeholders to trust and use comparative effectiveness information. A participant raised an important question about introducing CE information to insurance coverage: what do insured persons believe they have bought when they purchase health insurance? Will use of CE information be consistent with their understanding of what health insurance promises? Another participant responded that in giving a talk to a large group last week, a couple of hundred audience members conveyed that when they buy health insurance their understanding is that they are buying prepaid health care period! In other words, in that group at least, no one was anticipating discriminations to be made on the basis of comparative effectiveness. With regard to trusting the use of CE information, a participant commented: If HPHC were to work with ICER, I would expect to get the care I need, but I would also want my coverage to be affordable. CE information could be the sweet spot here it could help with both. I would want HPHC to explain how it uses CE in coverage decisions or benefit design and how doing that makes my insurance more affordable. I would want to know that the CE analyses were made by experts who did not have a conflict of interest that no one who could benefit from the outcome of the analysis was shaping the analysis. And all of this should be fully transparent. (not an exact quote) Steve told the group that the work of NICE (National Institute for Clinical Excellence) in England is widely trusted and accepted. He came away from the year he spent at NICE with the impression that the British population trusts the government much more than is true in the U.S. A participant commented that the fact that ICER is an independent, academically-based program makes it more trustworthy for him. He would trust CE information even more, however, if there was more than one entity doing the analyses, allowing for cross checking. Eliciting trust for CE information is a first step in making the information useful. The question then arises as to who will make use of it, and how. Participants suggested that no stakeholder group will be eager to take the lead. Employers lack the expertise to make discerning use of CE information, and many companies are in a strong cost cutting mode. Physicians could, in principle, be put at risk, but neither consumers not clinicians were enthusiastic about this. Given the negative public reactions to managed care in the 1990s, health plans would want to be very careful to cultivate societal support for making use of CE information in the future. Today s discussion touched briefly on some of the ways the U.S. health system could make use of CE information, such as tiered insurance products and value-based insurance design. The EAG hopes to have opportunities to deliberate in greater depth about policy options for using CE information in upcoming meetings. 5

6 Summary 1. The EAG evinced strong support for the importance of high quality, understandable information about comparative effectiveness of the kind ICER is developing. 2. The fact that (a) Medicare is predicted to become bankrupt in 2019, (b) Medicaid is strangling state budgets, and (c) it is harder every year for employers to continue to provide insurance for employees, (d) means that stakeholders are readier than in the past to make use comparative effectiveness information. 3. U.S society, however, will have a steep societal learning curve to become ready to apply comparative effectiveness information. Even though we all use CE information in our personal purchasing decisions, the way we have structured our insurance system has led to a cost blind mentality for health care. 4. The EAG felt that although CE information is imperfect, it is important for U.S. society to begin learning about it and finding ways to use it. 5. The EAG recognized that the May 15 th meeting was just a starting point. It hopes to continue working with the values dimensions of comparative effectiveness over time, just as it did with the development of consumer directed products. 6. The group thanked Steve Pearson for a superb introduction to the area of comparative effectiveness and congratulated him for the work he is doing in developing ICER. Jim Sabin 6