Writing in the June 2024 edition of ISPOR’s Value in Health journal, Nancy J. Devlin, PhD, Michael F. Drummond, MCom, DPhil, and C. Daniel Mullins, PhD look back on the history of QALYs in cost-effectiveness analysis and policy decision making, and why the backlash against QALYs in the United States is a setback for efforts to harmonize evidence development across the world’s HTA systems.

 

Introduction

The quality-adjusted life year (QALY) is over 50 years old.1 Debate about the ethical basis for the QALY and its use in cost-effectiveness analysis (CEA) and policy decision-making are almost as old (for example, see Harris,2 Rawles,3 and responses from Mooney,4 and Williams5). These (and other) early articles are worth rereading. Few of the arguments for or against the use of QALYs are new, although the rhetoric and policy discourse have evolved. Ongoing debates around the QALY run the gamut from technical methods issues, such as how best to establish health-related quality of life (HRQoL) values, to policy implications, such as how the cost/QALY threshold should be determined. At the center of the debate the fundamental question about whether the QALY itself is a valid measure persists.

Criticisms of QALYs and their use in CEA have gained momentum again, particularly 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. Therefore, the use of QALYs, or similar measures, in decisions concerning Medicare coverage and reimbursement is legislatively forbidden.6 Proposed legislation would expand this to place a ban on QALYs “and other similar discriminatory measures” in all federal programs.7

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 (HTA) has continued to grow. The use of QALYs and CEA has expanded beyond the original “HTA countries” (ie, United Kingdom, Canada, and Australia) to many countries in Northern Europe and into the evolving HTA systems in Asia, South America, and Africa. The United States is but 1 country and its healthcare system is anomalous in many ways. Yet, the rejection of the QALY in the United States could have important implications outside the country, most obviously because the United States is by far the largest market for pharmaceuticals in the world. The move against QALYs in the United States is also a setback for efforts to harmonize evidence development across the world’s HTA systems. This issue of Value in Health contains 4 articles of relevance to understanding the current debate around ethical, policy, and technical issues surrounding the QALY and its alternatives. Specifically, the articles address the topics of whether the QALY is discriminatory against certain subgroups of patients8,9 and whether alternatives to the QALY have good properties.10,11

 

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References

  1. Spencer A, Rivero-Arias O, Wong R, et al. The QALY at 50: one story many Soc Sci Med. 2022;296:114653.
  2. Harris Life: quality, value and justice. Health Policy. 1988;10(3):259–266.
  3. Rawles Castigating QALYs. J Med Ethics. 1989;15(3):143–147.
  4. Mooney QALYs: are they enough? A health economist’s perspective. J Med Ethics. 1989;15(3):148–152.
  5. Williams QALYS and ethics: a health economist’s perspective. Soc Sci Med. 1996;43(12):1795–1804.
  6. About the Affordable Care Act. S. Department of Health and Human Services; Published 2010. https://www.hhs.gov/healthcare/about-the-aca/index.html. Accessed March 23, 2024.
  7. R.485- Protecting Health Care for All Patients Act of 2023. Congress. Gov. https://www.congress.gov/bill/118th-congress/house-bill/485. Accessed March 23, 2024.
  8. Willke R, Pizzi L, Rand LZ, Neumann P. The value of the QALY. Value Health; Published May 2, https://doi.org/10.1016/j.jval.2024.04.018.
  9. Xie F, Zhou T, Humphries B, Neumann P. Do QALYs discriminate against the elderly? An empirical analysis of published cost-effectiveness analyses. Value Health; Published March 26, https://doi.org/10.1016/j.jval.2024.03.011.
  10. Basu Logical inconsistencies with expected utility theory may align better with patient preferences-a response to Paulden et al. Value Health; Published March 12, 2024. https://doi.org/10.1016/j.jval.2023.12.016.