Tuesday, July 16, 2024

ISPOR Examines Quality-Adjusted Life Years and Alternatives in Healthcare Decision-Making

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The Professional Society for Health Economics and Outcomes Research (ISPOR) announced the publication of a collection of papers examining the ongoing 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,” authored by Nancy J. Devlin, PhD, Michael F. Drummond, MCom, DPhil, and C. Daniel Mullins, PhD, provides a brief history of the quality-adjusted life year, discusses its ethical implications, and introduces four additional manuscripts that delve into the current debate around QALYs and their alternatives. All five papers were published in the June 2024 issue of Value in Health.

In their editorial, Devlin, Drummond, and Mullins highlight the recent resistance to QALYs in the United States, driven by anti-QALY lobbying from the pharmaceutical industry and opposition from patient groups. This resistance has led to political pressure on legislators, resulting in a legislative ban on using quality-adjusted life years or similar measures in Medicare coverage and reimbursement decisions. This backlash contrasts sharply with the global landscape, where QALYs continue to play a significant role in health technology assessments.

Potential Bias and Alternatives for Healthcare Decision-Making

The collection includes two papers addressing the potentially discriminatory nature of QALYs against certain patient subgroups, such as the elderly and those with disabilities. The first paper, “The Value of the QALY,” by Richard J. Willke, PhD, and colleagues, argues that QALYs, despite their imperfections, are valuable tools for measuring health benefits in population-level healthcare decision-making. The authors contend that the limitations of QALYs are well understood and that banning their use would deprive decision-makers of an essential measure of treatment benefits and harms.

The second paper, “Do QALYs Discriminate Against the Elderly? An Empirical Analysis of Published Cost-Effectiveness Analyses,” by Feng Xie, PhD, and colleagues, investigates whether age-based discrimination occurs in practice with quality-adjusted life years. Their analysis of published cost-effectiveness studies reveals no systematic difference in incremental cost-per-QALY estimates between interventions for those above and below 65 years old. Surprisingly, they find that technologies for older age groups are more likely to be deemed cost-effective, suggesting that further investigation is warranted.

The final two papers explore alternative measures to QALYs, specifically the health years in total (HYT) approach. In his letter, “Logical Inconsistencies With Expected Utility Theory May Align Better With Patient Preferences,” Anirban Basu, PhD, defends the HYT metric against criticisms from a 2023 paper by Paulden and colleagues. Basu argues that while HYT may violate certain axioms of rational choice theory, it might better reflect patient preferences and address the shortcomings of quality-adjusted life years.

Quality-Adjusted Life Year

Quality-Adjusted Life Year Alternatives Debated Amid Medicare Ban on Effectiveness Metrics

He emphasizes the need for alternative effectiveness metrics in the U.S. due to the ban on QALYs in Medicare decision-making. In their response, Mike Paulden, PhD, and coauthors reaffirm their critique of the HYT approach, addressing Basu’s points. They argue that the HYT approach has logical inconsistencies, such as violating the independence of irrelevant alternatives axiom, and lacks sufficient evidence to justify its assumptions.

In conclusion, Devlin, Drummond, and Mullins note that whether alternatives to QALYs will gain greater acceptance in the United States remains uncertain. They emphasize that reimbursement and pricing decisions for new medicines will continue to be made, regardless of whether information on benefits or costs is used explicitly. Even if the cost-per-quality-adjusted life year metric is not used, some approaches to balancing increased costs with gains in morbidity and mortality will always influence access to medicines.

This collection of papers provides a comprehensive overview of the ongoing debate over quality-adjusted life years, highlighting the need for continued discussion and research into alternative measures. The diverse perspectives offered in these studies underscore the complexities involved in healthcare decision-making and the importance of finding methods that balance ethical considerations with practical application. As the healthcare landscape evolves, the insights from these papers will be crucial in shaping future policies and practices.

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Resource: Professional Society for Health Economics and Outcomes Research, June 18, 2024

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