technologies, procedures, and methods of organizing and delivering care. The assessment of comparative value should begin by leveraging department-wide data sources in conjunction with supportive evidence from providers, payers, and health researchers. [bold added for emphasis]

I support having the secretary work with Congress to establish a capability to assess comparative effectiveness of the range of preventive and treatment approaches as described. However, I do not agree with including cost-effectiveness in the recommendation. The crux of my disagreement is that cost-effectiveness, which addresses the issue of collective health care costs, does not adequately protect the needs of individual patients to enhance their physical and mental health status. While cost-effectiveness studies have a societal value, equally important is how this information is used to benefit the individual. According to the IOM’s Roundtable on Evidence-Based Medicine, “Value in health care is expressed as the physical health and sense of well-being achieved relative to the cost. This means getting the right care at the right time to the right patient for the right price.” Such value cannot be accomplished if the social gain of managing health care costs is achieved at the expense of individual physical and mental health.

I am concerned that cost-effectiveness data based on averages will trump consideration of individual clinical value. Used this way, clinical effectiveness analyses could be used to limit coverage of treatments vital to particular individuals’ “physical health and sense of well-being.” In support of my dissenting opinion I offer the following observations.

  • Cost-effectiveness differs depending on both the type of patient and the kind of insurance or public program providing the financing: For example, the cost-effectiveness of providing expensive cancer treatment for a 35-year-old working mother could be very different from that of a 75-year-old retiree. Basing the assessment on averages could provide payers with justification to limit coverage for all. A fully integrated, prepaid health plan with a stable enrollee base might treat costly prescription drug treatment as cost-effective in avoiding potentially more expensive care, while a Medicare stand-alone prescription plan or an insurer facing rapid turnover in enrollees might view the cost-effectiveness very differently. This can lead to the denial of good treatments for those patients who have a clinical need for them,



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