Quality-adjusted life years: ethical implications and the Oregon plan.

• Author: La Puma, John

INTRODUCTION

Definition and Use

A QALY (quality-adjusted life years) is a numerical description of the value that a medical procedure or service can be expected to provide to groups of patients with similar medical conditions. QALYs attempt to combine expected survival with expected quality of life into a single number: if an additional year of healthy life expectancy is worth a value of one (year), then a year of less healthy life expectancy is worth less than one (year). (1)

QALYs represent a progression in the cost effectiveness analysis of health care. Health economists have struggled for decades to estimate the value of life, and may have been uncomfortable with life years gained as an outcome but have had little more to offer. (2)

Serious clinical ethical questions, however, have been raised about QALYs (3) and about the explicit rationing of care in America. (4) This analysis does not attempt to take on the latter questions but instead reviews QALYs' methods and historical development and attempts to identify the ethical issues they present. The method of rationing health care formally proposed in Oregon in 1990, and this method's medical and normal inadequacies, are described. Rationing health care with QALYs or QALY-like scales now seems reasonable to many thoughtful people but actually will serve to deny medically necessary services to those who are most vulnerable--persons who are medically indigent, children, and older persons.

QALYs' Methods

QALY calculations are based on measurements of the value that individuals place on expected years of survival. Measurements can be made in several ways: by techniques that simulate gambles about preferences for alternative states of health, (5) with surveys or analyses that infer willingness to pay for alternative states of health, (6) or through instruments that are based on trading off some or all likely survival time that a medical intervention might provide in order to gain less survival time of higher quality. (7)

In theory, these techniques could be employed to elicit QALYs for an individual patient facing a choice between alternative therapies that yield different likelihoods for pain reduction, ability to engage in activities of daily living, and life expectancy. A patient with severe angina and triple vessel disease will, for example, generate different QALYs with bypass surgery, without surgery, and with medications because each of these treatments had a different effectiveness and is associated with a different quality of life. A patient with the same symptoms--severe angina--and single vessel coronary artery disease would generate still different QALYs from the former patient.

The methods used to calculate QALYs are still under development. (8) QALY assessments have been shown to vary by how health states are described, how outcomes are reported, how scales are generated, and how surveys are administered. (9) The technical or methodological issues involved in utility measurement (10) and quality of life assessment are not belabored, but they are controversial, variable, and in need of refinement.

Cost Effectiveness Analysis in Health Policy

QALYs have several clear benefits. Cost effectiveness analyses attempt to assess how efficiently interventions are being used, given how much they cost. When divided by cost, QALYs can yield a measure of cost effectiveness (11) and can help establish priorities for funding, as Oregon hopes to do. Interventions of highest priority (which are those that yield the most QALYs per dollar) would receive the most resources: the more QALYs per dollar, the more resources and the greater funding of that intervention. In theory, QALYs can help provided a policy direction for an efficient utilization of health care resources that already exist and for the allocation of new resources.

QALYs attempt to clarify judgments about quality of life. By identifying specific quality states, survival estimates, and societal preferences, QALYs may improve the efficiency and objectivity of medical decisionmaking, reducing the subjectivity of judgments about quality of life. (12)

QALYs have another benefit: they are a potential result of community medical ethics--the public identification, prioritization, and implementation of an equitable, virtuous distribution of health care resources. Accurate, detailed knowledge of community preferences is essential to allocate resources fairly. At least ten state programs in community clinical ethics now exist. (13) Oregon Health Decisions, for example, helped persuade the state legislature not to fund organ transplantation because it received a lower community priority than preventive programs. (14) Although coverage for transplantation was reinstated after a public outcry, (15) the concept of small town meetings to allocate resources has broad appeal.

QALYs as a Rationing Tool

Oregon's ranking of health care services is precisely the way in which QALY researchers QALYs to inform resources allocation decisions, especially large-scale decisions that deploy resources across disease states and population groups. In theory, and partly in fact in Oregon, a QALY analysis compares the merits of devoting resources to an intervention likely to extend the lives of a particular population for a specific period, but with high levels of disability and distress, against another intervention, which may not yield as many years of life saved but generates higher levels of subjective well-being.

Cost per QALY analyses are motivated by the concept of scarcity: if resources were unlimited, rationing would be unnecessary. In the United Kingdom, there is explicit rationing of some health care services, requiring physicians to be both caretakers and resource agents. (16) In the United States, rationing is accomplished implicitly through patients' differential ability to pay: tens of millions of uninsured and underinsured people, including patients receiving Medicaid, do not have equal access to health care. (17) Aaron and Schwartz (18) found that British doctors most often find medical reasons to deny a needed treatment (e.g., dialysis) to a patient. Such patients are too old, too sick, or too unlikely to benefit; doctors generally do not say that the resources is relatively scarce and unavailable.

Explicit health care rationing, with selected priorities for funding, has been proposed in Oregon (19) and by scholars. (20) Oregon state officials hope to ration health care to the poor, using ranking of 709 health care services, from antibiotics for pneumococcal pneumonia (#1) to life support for extremely low birth weight neonates (#708) and anencephalic babies (#709). Oregon's plans call on physicians to enact allocation decisions by rationing care at the bedside and, at minimum, could benefit from a clear explication of how QALYs have developed.

Historical Development

Technical Development

Derived from operations research in engineering and mathematics, QALYs were first introduced by decision analysts and researchers in the United States. (21) Weinstein and Stason described QALYs as a way of elucidating the trade-offs between quality of life and additional survival, representing "the net health effectiveness of the program or practice in question." (22)

In 1978 in Britain, Rosser and Kind reported the results of psychometric testing of seventy selected patients, voluntaries, doctors, and nurses. The...