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Assessing and Improving Value in Cancer Care: Workshop Summary 9 Toward a Shared Understanding of Value The final discussion of the workshop, Dr. Peter Bach of Memorial Sloan-Kettering Cancer Center explained, had two aims: First, all six moderators from the workshop’s panels would provide a synthesis of the discussions they facilitated. Second, Dr. Bach extended an invitation to all the workshop attendees to synthesize what they had learned over the course of the workshop by raising key remaining questions, suggesting next steps, or proposing solutions for assessing and improving value in cancer care. Dr. Bach began the discussion with his impressions of the workshop to that point. He emphasized that cancer is not a single disease but many different diseases, some with tremendous opportunity for cure and others with very little. These differences have implications for potential value-based insurance design for cancer therapies, he said. If value-based insurance design were applied to cancer care, patients would not be penalized financially just for being diagnosed with cancer. For therapies that are not effective, however, perhaps patients should be financially discouraged from pursuing them through value-based insurance structures. Promoting these changes through value-based insurance design in oncology could greatly improve value in the care delivered to cancer patients. Dr. Bach reiterated another theme from the workshop—that many trials used for Food and Drug Administration (FDA) treatment approval produced too little information of use to payors, providers, or patients. The trials and their outcomes are not patient centered, and their narrow eligi-
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Assessing and Improving Value in Cancer Care: Workshop Summary bility criteria make it difficult to apply findings to real-world populations, undercutting their ability to determine treatment effectiveness. To solve this problem, Dr. Bach asked, how can we develop evidence for cancer drug effectiveness after FDA approval? On the theme of pharmaceutical pricing, Dr. Bach reviewed several approaches the workshop had discussed. Value-based pricing was one approach in which the price of a drug would be based on the health return of that drug, expressed in terms of cost per QALY, for instance. Another approach was the United Kingdom’s NICE model with an explicit upper limit on cost per QALY to drive down prices. Coinsurance, or increased co-pays for more expensive or less effective drugs, came up a number of times as a way to sensitize patients to higher drug prices and drive manufacturers’ prices down. Alternatively, a reimbursement-structured model, Dr. Bach said, would establish clinically-based drug interchangeability criteria to increase direct competition between drugs and manufacturers, interrupt the monopoly pricing structures manufacturers now benefit from, and drive down prices. High coinsurance burden has ethical challenges, Dr. Bach said. If patient sensitivity to price varies as a result of different coinsurance rates, this may interfere with patient autonomy. There is no question that higher co-pays reduce utilization, and for tier-4 drugs with a coinsurance rate of 20 percent, the patients’ financial disincentive can be on the order of thousands of dollars a month or tens of thousands of dollars a year. An intriguing question, Dr. Bach said, was whether the financial burden of the co-pay poses an ethical risk to autonomy, or the simple presence of coinsurance of any size is enough to be ethically problematic. Lastly, Dr. Bach reiterated the theme that clinicians at the bedside should not be expected to ration care on their own, especially in cases when their patients may benefit from treatments with extraordinarily high costs. Dr. Bach had concerns about putting clinicians in this role—given that clinicians’ ability to provide evidence-based care has been uneven at best, should they be solely responsible for limiting care at the bedside? The reality is that clinicians have a strong independent streak and feel that they should be autonomous decision makers, and they are unlikely to accept external pressures to ration care. Dr. Bach then turned to the panel of moderators for their comments.
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Assessing and Improving Value in Cancer Care: Workshop Summary WORKSHOP MODERATOR PERSPECTIVES Clinician–Patient Communication and Its Influence on Value About 80 percent of cancer patients in this country are treated in the community, where physicians are feeling considerable strain and salaries are declining, said Dr. Lichter. The landscape of oncology is going to change as a result, and those of us in the oncology community will have to decide whether we want to sit back and let that happen or be more assertive, envision the oncology system we want for our patients, and then help create it. The first panel talked about communication, Dr. Lichter said, and it would be hard to find a topic more pertinent to value in cancer care, or one with greater potential to affect value in the near term. We can all communicate better. Communication is a learned skill that all of us, trainees and experienced practitioners alike, can continually improve upon. Ultimately these skills should be used to better engage in end-of-life discussions, set realistic goals, and communicate truthfully and openly with patients. At ASCO, we want to play our role, Dr. Lichter said. The ASCO Cost of Care Task Force has been working for a year; learning modules to improve physician communication skills are being developed, and informational materials have been made available to help physicians and patients engage in difficult conversations about costs of care. The Quality Oncology Practice Initiative has the ability to measure many of the outcomes relevant to cancer care value through the 400 practices it tracks, and this data could be used to benchmark best practices and drive improvement in oncologists’ performance on a large scale through self-correction among academics and the community oncologists alike. Dr. Lichter also said that ASCO, working with the NCCN, would continue to actively develop clear practice guidelines not just for early-stage cancer but late-stage disease as well. Lastly, oncology is a natural fit for value-based insurance design, Dr. Lichter said. Clearly, the co-pay for highly effective treatments such as trastuzumab, which reduces a patient’s chance of recurrence by 50 percent, should not be the same as the co-pay for the least effective fifth-line therapy. This is an area where progress can be made.
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Assessing and Improving Value in Cancer Care: Workshop Summary Generating Evidence About Effectiveness and Value Many dimensions of value have been covered at this workshop, Dr. Cohen said. His panel, he explained, approached value in terms of outcomes and effectiveness. Dr. Woodcock’s presentation elucidated the ways in which drug efficacy and safety were established through the FDA approval process. A challenge that remained for the FDA was to incorporate patient-specific outcome measures, among other challenges. In his presentation, Dr. Sargent posed the challenge of predicting effectiveness from efficacy, citing limitations of RCTs and the utility of large-scale observational studies. Cost was largely absent from this panel’s discussion, Dr. Cohen explained. In fact, Dr. Woodcock made it clear that cost-effectiveness analysis did not factor into the FDA’s drug approval process at all. Value and the Oncology Market The speakers in Dr. Lerner’s panel, he said, discussed the poor incentive structures in oncology, the numerous constituencies to be taken into account when pharmaceutical manufacturers price a drug, and the barriers to generating meaningful cost-effectiveness data in clinical trials. Reflecting on the workshop as a whole, Dr. Lerner added that the cancer care community should provide better evidence-based information directly to patients, whether through informed consent or other routes. The solutions for improving value in cancer care are unlikely to come from within the professions with all of its competing goals, Dr. Lerner said. Instead, informing patients and empowering them with a different role in their care could be much more productive. Value in Cancer Practice: Health Insurer Perspectives Oncologists are like the rest of us, Dr. Ramsey said. They are like other physicians too, whether in primary care or other specialties. Speaking as a primary care physician, Dr. Ramsey said we all want value-based health care and we all want to consider the impacts of health care decisions on society’s shared resources, but we are conflicted when faced with the patient in front of us who is in need and we want to help. As a result, most physicians’ cost-effectiveness thresholds are probably higher than they or economists would like.
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Assessing and Improving Value in Cancer Care: Workshop Summary Cost-effectiveness seems to be health care’s “third rail” in the United States—no one will touch it. Why then is the use of cost-effectiveness so well-accepted in Europe? While there may be interest groups and policy makers who would like to avoid considering cost-effectiveness in this country, Dr. Ramsey thought that we were ready as a society to confront costs in health care, and understanding cost-effectiveness would be a transparent way to begin the discussion. Lastly, Dr. Ramsey reiterated that there is considerable variation in oncology practice, and reducing this variation from the moment a patient is diagnosed with cancer seems a logical target for the cancer community’s efforts. Ethical Issues for Value-Based Decision Making in Oncology Dr. Moses reiterated suggestions from the speakers on his panel. One need that was presented, he said, was a willingness to ration last-chance care at the end of life. He also emphasized the need for oncologists to better inform patients and participate in care decisions at the end of life. Improving Value in Oncology: Ways Forward Since our current national health reform discussion is focusing on universal coverage, it tends to overlook the related issues of cost and coordination. Yet much of the discussion at this workshop has been about costs and coordination of care near the end of life of cancer patients, Dr. Garrison said. The U.S. health care system has often been called a “blank check” health care system in that those of us who have excellent private health insurance are able to receive any care for which we expect a marginal positive health benefit, regardless of the societal marginal cost, Dr. Garrison said. This incentive for socially inefficient use underlies our high share of medical spending and its high growth rate. Dr. Garrison asked: How will we help oncologists constrain costs or support their treatment decisions in cases where the potential for a marginal clinical benefit exists but it is small relative to the marginal costs? That is the challenge. The tools of cost-effectiveness analysis can help us to address these trade-offs, thereby addressing the value question. What do we mean by value? Dr. Garrison said that he was comfortable describing value from an economic perspective as cost-effectiveness. But there were other types of value that emerged during the workshop that
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Assessing and Improving Value in Cancer Care: Workshop Summary need to be included in the calculus for value in cancer care. There is value to patients in having an opportunity for treatment benefit, in reducing uncertainty through better information, and in personalizing medicine, Dr. Garrison asserted. These types of value are not normally included in the calculation of cost-effectiveness, but they are important benefits that should be measured and considered. GROUP DISCUSSION OF VALUE IN CANCER CARE Workshop Attendee Perspectives Building on Dr. Rossi’s presentation, Dr. Ganz concluded that the price that pharmaceutical manufacturers choose at the launch of a drug may not be the appropriate price once it has been studied in a larger population or earlier in the course of disease. While drug prices at launch may be too high for their survival benefit, if the drug is very valuable when studied in larger populations, pharmaceutical manufacturers should not be penalized and forced to set artificially low initial prices. Dr. Ganz proposed that creative solutions be sought to address this problem of dynamic pricing in oncology, which could help avoid drugs with such high prices at launch while assuring that drugs are priced according to benefits throughout their life cycle. Dr. Ganz also suggested that some mechanism be developed to collect data on outcomes of therapies paid for by insurance plans by using the data those plans already collect. Perhaps pharmaceutical manufacturers, the Centers for Medicare and Medicaid Services (CMS), or some other funder could support this research to benefit the overall societal good. This could be a way to do large-scale studies without concerns over whether those with vested interests (manufacturers, clinical researchers, etc.) would provide support, and it could deliver large amounts of real-world information. Dr. Murphy raised a number of points contrasting pediatric oncology with adult oncology. In pediatric oncology, she said, treatment tends to be protocol-based to a greater extent, and few patients are treated in the community. Also, most pediatric oncologists are salaried. If adult oncologists were also paid on a salary structure, this could remove remunerative conflicts of interest that drive provision of fifth- or sixth-line chemotherapy with little effectiveness. Dr. Chernew commented on the distinction between those patients who pay a significant price for care that benefits them and those who pay the
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Assessing and Improving Value in Cancer Care: Workshop Summary same price for futile treatment. Ethically, the fundamental problem is not that the latter patients are charged high prices for futile treatment—it is that they are encouraged to pursue the futile treatment at all. Dr. Chernew tied this to a second point on the need for broader, systems-level research into the structures and incentives in place that encourage physicians to practice in the ways that they do. Dr. Vikram said that the NCI had in the past funded a wide variety of projects in addition to research, from guidelines development to building public awareness, but the shrinking NCI budget had curtailed the scope of its work. With a mandate from Congress and greater funding, Dr. Vikram was confident that the National Institutes of Health, and NCI in particular, could expand its role to include research in areas relevant to value in cancer care, such as comparative effectiveness or research to help oncologists make decisions at the bedside. ATTRIBUTES AND METRICS OF VALUE IN CANCER CARE Dr. Ramsey invited all those in attendance at the workshop to consider and comment on attributes of value in cancer care and metrics for measuring value. Synthesizing common themes from the workshop, he presented a list of attributes and metrics of value in cancer care, as well as stakeholder perspectives to be considered (Table 9-1). Were there things missing from these lists, Dr. Ramsey asked the audience, or things that should not be included? Hope should be added as an attribute of value, said Dr. Ganz. Social equity should be added as an attribute of value, said Dr. Smith. Another participant suggested adding the public at large or a societal perspective to the list of stakeholder perspectives, as well as adverse events associated with treatment to the value attributes. Variation in care and standardization through compliance with guidelines should be added as a metric, said Dr. Moses. Mr. John Frick of the Blue Cross and Blue Shield Association suggested that the metrics of value should include the number of generic biologics available in the marketplace. Dr. Ganz suggested coordination of care as a value metric. At the end of this discussion and the workshop overall, the list of value metrics, attributes, and stakeholder perspectives included all those listed in Table 9-1.
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Assessing and Improving Value in Cancer Care: Workshop Summary TABLE 9-1 Proposed Value Attributes, Value Metrics, and Stakeholder Perspectives Attributes of Value Metrics of Value Pertinent Stakeholder Perspectives Outcome Attributes Economic Metrics Patient perspective, including families or other social supports Physician or clinician perspective Health insurer perspective—public and private Pharmaceutical manufacturer perspective Societal perspective—the public at large Survival—duration of life Quality of life Adverse events Time to progression Tumor response Cost per QALY Equity Metrics Variation in care Financial hardship Workforce or service shortages Access to insurance and appropriate services Disparities in care Cost Care Attributes Access to care Quality of care Communication Social equity Innovation Metrics Willingness to pay for cancer treatment research FDA new drug applications Generic treatments Biosimilars Patient-Centered Attributes Compassion and respect Opportunity for treatment benefit Choice Hope Care Metrics Quality of clinician–patient communication Coordination of care Innovation and Future Discovery SOURCE: Ramsey presentation, February 10, 2009.