Editor’s Note: This perspective was originally published on Health Affairs Forefront on April 21, 2023.
The US House of Representatives is considering legislation (HR 485) that would prohibit the use of the quality-adjusted life-year (QALY) and similar measures for coverage and payment determinations under all federal and state health care programs—affecting both Medicare and Medicaid. The QALY is an important outcome measure used by many cost-effectiveness researchers, yet also represents a tool for making comparative effectiveness assessments of interventions that address the health needs of populations.
Language in HR 485 includes restrictions on the use of evidence or information obtained from government or non-government entities that might then use a price that is derived from an “adjusted life year (or such a similar measure) or using averages or other pricing metrics that directly or indirectly take into account such prices.” The concern expressed by some members of Congress is that the QALY systematically discriminates against elderly, disabled, or terminally ill Americans when used to inform resource allocation decisions or price determinations. This concern is further referenced in the initial guidance for the Medicare Drug Price Negotiation Program. We argue that while the QALY is not perfect, valid alternatives exist that address concerns and that will facilitate explicit consideration of both quality and length of life in comparative effectiveness assessments.
Comparative effectiveness evidence should include quality of life measures
While the QALY remains controversial, placing value on both life extension and quality of life should not be. Not all medical interventions financed through federal or state resources extend life. Interventions that improve patient quality of life without extending life are essential for countless patients with chronic diseases. For example, many of the Food and Drug Administration-approved pharmaceutical treatments for patients with chronic obstructive pulmonary disease and emphysema improve symptoms and lung function and also reduce burdensome and expensive disease exacerbations. The impact that these interventions have on well-being and quality of life is substantial and important to patients and their families. Yet, there is no direct evidence that these treatments improve life expectancy. There also are disease states in which patients face difficult treatment decisions that require tradeoffs between quality of life and length of life, such as in cancer. Failing to consider and value improvements in quality of life might penalize treatments in coverage and payment determinations and may limit access for patients suffering from poor quality of life.
Alternatives to the QALY
In 2015, Professor Richard Cookson enumerated and discussed the ethical concerns and issues regarding discrimination with the QALY. The US National Academy of Sciences took up this issue, too. In both reports, the authors find valid reasons for measuring both quality of life and longevity improvements but acknowledge some limitations of the QALY as a vehicle for doing so. When used for policy evaluation, the sum of the comparative QALY measure produced by a health intervention is agnostic to whom the QALYs accrue. On this point the National Academy of Sciences report concluded that, “Concerns about how one accounts for distributive justice—helping those in most need first, or placing priority on life-saving rather than quality-enhancing procedures—and whether these measures are in fact discriminatory, are likely areas of discomfort within the policy community.”
Since these reports were completed, scientists (including five of us) have created alternatives to the QALY that retain the ability to assess and value well-being and quality of life to inform policy and resource allocation decisions without discriminating against any members of society.
These tools were designed specifically to mitigate the concerns about the QALY and provide a means by which population health measures can be explicitly considered as part of policy evaluations. The equal value of Life Years Gained (evLYG), Healthy Years in Total (HYT) and the Generalized Risk-Adjusted QALY (GRA-QALY) methods are important advances in the fields of population health measurement and cost-effectiveness research. In the National Disability Council’s report on “Alternatives to QALY-Based Cost-Effectiveness Analysis for Determining the Value of Prescription Drugs and Other Health Interventions,” they write that the evLYG, “eliminates the risk of undervaluing life-extension for people with disabilities,” and that, “disability rights advocates have described HYT as a better approach to standard [cost-effectiveness analysis] CEA because it removes the devaluation of life extension of people with disabilities.”
Health care authorities in other countries (Australia, Canada, France, Germany, Japan, Netherlands, Sweden, and the UK to name a few) use the outcomes of comparative effectiveness research, including improvements in both life expectancy and quality of life (such as that summarized in the QALY), to inform their population health care funding decisions. They do so because they understand that resource allocation decisions can have positive and negative effects on population health. The full range of comparative effectiveness evidence on treatments is useful, equitable, and necessary for the efficient use of scarce health-sector resources.
In the US, we do not routinely—nor as a matter of federal policy—use comparative effectiveness research based on the QALY to inform pricing, coverage, and reimbursement decisions. The legislative intent of HR 485 is to prevent the Centers for Medicare and Medicaid Services (CMS) and the Medicare Price Negotiation Program from considering any evidence of comparative effectiveness that includes the “QALY and other similar measures.” While the QALY has certain limitations, we question why the phrase “other similar measures” has been included in HR 485 and in the initial CMS guidance for Medicare Price Negotiation, when valid alternatives that address concerns by the disability community exist. In fact, casting a broad net could very well harm the people the legislation intends to protect.
Conclusion
We now have useful and valid alternatives that allow for the assessment and valuation of treatments that improve population health without discriminating against vulnerable patient populations. Indeed, these new measurement approaches can even promote health equity by recognizing the additional value of improving health outcomes for vulnerable populations. Many Americans continue to suffer the burden of poor quality of life. Congress should ensure that federal and state agencies that incorporate comparative effectiveness research into decision making, such as CMS, can explicitly recognize the value of reducing this burden to improve patient outcomes by acknowledging valid measures that incorporate life extension and quality of life without discrimination.
Authors’ Note
The opinions expressed in this article are the authors’ and do not necessarily reflect the views of their respective institutions.
Sullivan, S. D., Lakdawalla, D. N., Devine, B., Grueger, J., Garrison Jr, L. P., Carlson, J. J., … & Basu, A. (2023). Alternatives To The QALY For Comparative Effectiveness Research. Health Affairs Forefront.
10.1377/forefront.20230419.896238
Copyright © [2023] Health Affairs by Project HOPE – The People-to-People Health Foundation, Inc.
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