Confronting the Backlash Against QALYs: Key Insights From Leading Health Economists

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Lawrenceville, NJ, USA—June 18, 2024—ISPOR—The Professional Society for Health Economics and Outcomes Research announced today the publication of a collection of papers that examine the long-standing debate surrounding the use of quality-adjusted life years (QALYs) and alternative measures in healthcare decision making. The lead editorial, “QALYs, QALY-Like Measures, or Neither? The Debate Continues,” by Nancy J Devlin, PhD, Michael F. Drummond, MCom, DPhil, and C. Daniel Mullins, PhD, provides a brief history of the QALY, describes the ongoing discussions about its ethical basis and use in cost-effectiveness analysis and policy decision making, and introduces 4 additional manuscripts relevant to understanding the current debate around the QALY and its alternatives. All 5 papers were published in the June 2024 issue of Value in Health.

In their opening editorial, Devlin, Drummond, and Mullins highlight the recent resistance to the QALY in the United States, where anti-QALY lobbying by the pharmaceutical industry and opposition to the use of QALYs by patient groups has placed political pressure on legislators. As a result, the use of QALYs or similar measures in decisions concerning Medicare coverage and reimbursement is legislatively forbidden. This backlash against the QALY in the United States stands in stark contrast to the rest of the world, where the use of the QALY in evidence to inform health technology assessment has continued to grow.

The collection includes 2 papers that address the potential discriminatory nature of QALYs against certain subgroups of patients, such as the elderly and those with disabilities. The first of these, “The Value of the QALY,” by Richard J. Willke, PhD and colleagues, argues that the QALY is a useful, if imperfect, tool for measuring health benefits as an input to population-level healthcare decision making, that its limitations are well understood, and that with appropriate use will not be discriminatory. Furthermore, the authors contend that banning QALY use would deprive decision makers of an important summary measure of the benefits and harms of a treatment. In the second paper of the pair, “Do QALYs Discriminate Against the Elderly? An Empirical Analysis of Published Cost Effectiveness Analyses,” Feng Xie, PhD and colleagues go a step further, testing whether age-based discrimination occurs in practice when using QALYs. Their analysis of published cost-effectiveness studies reveals no evidence that incremental cost-per-QALY estimates systematically differ between interventions for those above and below 65 years old. Surprisingly, they find that technologies for older age groups are actually more likely to be deemed cost-effective, as indicated by higher odds ratios for those over 65. This intriguing finding warrants further investigation, although the authors note that publication bias or other factors could mean that cases where treatments for older adults were not cost-effective may be underrepresented in the literature.

The last 2 papers of the collection consider the properties of alternative measures to the QALY, specifically with respect to the health years in total (HYT) approach. Anirban Basu, PhD, in his letter “Logical Inconsistencies With Expected Utility Theory May Align Better With Patient Preferences,” defends the HYT metric against criticisms posited in a 2023 paper by Paulden and colleagues. Basu argues that while HYT may violate certain axioms of rational choice theory, it may better reflect patient preferences and address the shortcomings of QALYs. He emphasizes the need for alternative effectiveness metrics in the United States due to the ban on the use of QALYs in Medicare decision making. In the author’s reply, Mike Paulden, PhD and his coauthors reaffirm their critique of the HYT approach, addressing several points raised by Basu. They assert that the HYT approach has logical inconsistencies, such as violating the independence of irrelevant alternatives axiom, and lacks sufficient evidence to justify its assumptions. The authors emphasize the importance of proposing new ideas while recognizing the limitations of the HYT method.

Devlin, Drummond, and Mullins provide an apt conclusion: “Whether the alternatives to the QALY will gain greater acceptability in the United States remains to be seen. In the meantime, reimbursement and pricing decisions about new medicines will be made regardless of how or whether information on benefits or costs is used explicitly to inform them. Thus, even if the cost per QALY metric is not used, some explicit or implicit approach to balancing increased costs with gains in morbidity and mortality will always influence access to medicines.”

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