Will Evidence Ever Be Sufficient to Resolve the Challenge of Cost Containment?

The fact that both new forms of diagnostic testing and emerging therapies are expensive and becoming more so is well-known within the world of cancer care and insurance in the United States. The cost for the treatment of cancer in the United States has at least doubled since 1987, and outlays for cancer drugs exceeded 20 billion dollars in 2009. Many other nations are struggling with the escalating cost of cancer care as well. There is no reason to presume that the cost of care for cancer will decline in the coming decade. Efforts at cancer prevention are not the primary focus of the American public or economic policy, the obesity epidemic continues to grow, the population continues to age, new genomic tests will soon be available to assess cancer risk, and funds for more research for the diagnosis and treatment of cancer continue to flow, promising the possibilities of benefit or even breakthroughs but no relief from rising costs. This cost explosion comes at a time when the United States has enacted health reform legislation in an effort to widen access to basic health insurance; the Patient Protection and Affordable Care Act (PPACA) became law on March 23, 2010. The legislation brings the Untied States in line with other developed nations, which have long guaranteed health insurance coverage to their citizens. Before the PPACA, the United States had been getting by with huge expenditures on cancer care and other health care interventions by allowing tens of millions of citizens to go uninsured or underinsured. Citizens wheezed and bled their way to emergency rooms while the rich and upper class jetted off for executive physicals, enjoyed the attention of concierge doctors, had their genomes analyzed for health risks, or sought entry into the newest clinical trials for their advanced brain, colon, or lung cancers. Health reform may help tamp down these gross inequities in American health care. However, it is not clear precisely what tests and treatments will be covered by mandated health insurance. Unless taxes increase, the only way to pay for moderately robust health coverage is, in the view of most policy makers, to try to restrain health care costs by paying only for what works well. Given that tax increases are not in the offing, there is plenty of language in the new law about the importance of evidence for determining coverage. For example, under Title VI, section 6301, PPACA “creates the Patient-Centered Outcomes Research Institute, which will establish research priorities and studies that compare the effectiveness of medical and surgical treatments.” Title VI, section 6301 gives the secretary of the Department of Health and Human Services authority to use “evidence and findings from [comparative effectiveness] research” to make coverage determinations under certain statutory conditions. The PPACA law emphasizes evidence-based medicine as a crucial tool for reigning in the escalating costs of cancer diagnosis and treatment. The policy presumption is that the compilation of sufficient evidence will allow for noncontroversial, rational coverage decisions to be made. It will also allow the avoidance of rationing. For many proponents of health reform, cost containment requires nothing more than a long hard look at the evidence to forge consensus about what to cover. To date, the faith that policy makers in the United States and elsewhere have in the sufficiency of evidence seems unfounded. Last year the US Preventive Services Task Force evaluated routine mammograms for women older than age forty years. This blue-ribbon panel concluded that the evidence does not support routine screening mammography in women age 40 to 49 years. There is too much radiation, and there are too many false positives and too many unnecessary procedures. The evidence supports starting regular mammograms every other year at age 50 years. Few wanted to hear this evidence—not doctors making money from mammograms or the companies making the required equipment to perform them; not women who had been told for decades that regular mammograms were their best weapon against breast cancer; and not patient advocates who have long urged mammograms on their constituencies as a prudent, preventive behavior. As soon as the panel’s analysis of the evidence was made public, the administration was on the run from the evidence of its own panel. Department of Health and Human Services Secretary Kathleen Sebelius, who has the authority in PPACA to use evidence to help make coverage determinations, threw the evidence out the window. She told CBS News anchor Katie Couric that she wasn’t refuting the recommendations but that women should “do what they’ve always done” and talk to their doctors about health care decisions. True, she did not deny the evidence. She just said it should not matter; individual provider judgment and patient values should guide decision making, which is more or less how things were before the panel’s evidencebased assessment. This is hardly the only recent example in which evidence regarding cancer has yielded to politics, money, and emotion. The decision this November by Medicare to cover sipuleucel-T(Provenge; Dendreon, Seattle, Washington), a new vaccine that extends life for some men with advanced prostate cancer by 4 months at a cost of nearly $100,000, is another. In the United Kingdom, evidence-based decisions regarding coverage have been undermined by efforts to provide JOURNAL OF CLINICAL ONCOLOGY COMMENTS AND CONTROVERSIES VOLUME 29 NUMBER 15 MAY 2