Measuring Value—The QALY Turns 50: What Has It Achieved and What Is Its Future?

By John Watkins, PharmD, MPH, BCPS, Managed Care Perspectives, LLC

For almost half a century, the principal measure of value (net health gain) in cost-effectiveness analysis (CEA) has been the quality-adjusted life year (QALY). Several organizations have offered frameworks that include additional value dimensions not captured by the QALY. In 2018, an ISPOR Special Task Force assembled a more comprehensive list known as the “ISPOR value flower” graphic.¹ QALYs are calculated by health economists around the world, but most countries don’t use them in formal decision-making processes. Even its strongest proponents acknowledge the QALY’s shortcomings. Willke and colleagues recently summarized the position of ISPOR’s scientific leadership. They “emphasize that the QALY can provide useful information for decision making, with appropriate use it will not be discriminatory, and it should be available for use in combination with other summary measures of health benefit.”²

History and Present Use

The general concept of cost-utility analysis had been discussed since the late 1960s.  George Torrance and colleagues first published a description of the methodology in 1972,³ and the term “QALY” was first used in a peer-reviewed publication by Zeckhauser and Shepard in 1976.⁴  Since then, it has traveled around the world, yet according to Michael F. Drummond, MCom, DPhil, Professor Emeritus, Centre for Health Economics, University of York, England, United Kingdom, only a small number of countries actually use QALYs in health technology assessment (HTA) and decision making. Others use them alongside the formal decision-making processes of their governments. In the United States, for example, the Institute for Clinical and Economic Research (ICER) routinely includes CEA in its reports, presenting both QALY- and equal value life year (EVLY)-based cost-utility ratios. Use of the QALY by federally funded payers to determine coverage is explicitly forbidden by law, but some private payers use ICER’s work to inform formulary and coverage policy decisions and to negotiate price.

Use of the QALY in formal decisions is mostly confined to Europe. In 2020, Torbica and colleagues surveyed its use in 36 Organisation for Economic Co-operation and Development (OECD) countries, finding that Australia, Belgium, Canada, Czechia, Estonia, Finland, Hungary, Iceland, Ireland, Israel, Mexico, The Netherlands, New Zealand, Norway, Poland, Portugal, Slovakia, Slovenia, Sweden, and the United Kingdom made extensive use of QALYs, whereas Austria, Chile, Denmark, France, Germany, Greece, Italy, Japan, South Korea, Latvia, Lithuania, Luxembourg, Spain, Switzerland, Turkey, and the United States were low utilizers.⁵

“Only a small number of countries actually use QALYs in health technology assessment (HTA) and decision making. Others use them alongside the formal decision-making processes of their governments.” — Michael F. Drummond, MCom, DPhil

France and Germany do not formally use the QALY, Drummond notes, having adopted systems that score new drugs based on their evidence of incremental net clinical benefit, similar to ICER’s Evidence Ratings. They use these ratings in price negotiations with manufacturers in lieu of formal CEA although France consults cost-utility modeling in situations where the manufacturer is claiming that the drug is innovative. Australia, Canada, and New Zealand follow the English model developed by the National Health Service (NHS) and the National Institute for Health and Care Excellence (NICE). Other countries outside Europe that make some use of QALYs in HTA include Colombia and Taiwan. Federico Augustovski, MD, MSc, PhD, Director, Health Technology Assessment and Health Economics Department and Professor of Public Health, University of Buenos Aires, Argentina, adds, “Local value sets for preference assessment instruments (ie, EQ-5D) for local QALY estimations were derived in several countries in the region (Argentina, Brazil, Chile, Colombia, Ecuador, Perú, and Trinidad and Tobago).” Some of these were not reviewed by Torbica because they are not OECD countries. The level of detail Augustovski describes shows that thoughtful work supporting QALY calculation is happening in countries that have not officially incorporated CEA in their formal HTA process.

Factors Affecting Adoption

Torbica and colleagues studied factors associated with formal adoption of QALYs in decision making. “It appears that…culture, values, and institutional context have an influence on the use of HTA and economic evaluation in healthcare, either directly or indirectly.”⁶ The most important predictor of QALY use was the presence of a national single payer health system. Such systems exclusively control market access and thus have strong price negotiating leverage. A fixed budget, which calls attention to tradeoffs and marginal costs, is another factor, as is transparency. Most such systems provide access to records, which is not the case with private payers. Torbica et al’s path model showed direct association between QALY use and institutional context (type of health system and administrative tradition). Social values (efficiency, equity, personal responsibility, etc) appeared to influence indirectly through the institutional context.⁷

Cultures have differing concepts of health, illness, medicine, and the balance between individual autonomy and overall welfare of society. Countries like England highly value horizontal equity and have a greater sense of social solidarity. In principle, everyone in England can access care, but high-cost drugs and medical technologies strain limited resources, resulting in queuing for procedures such as advanced imaging and surgery. This form of rationing can harm patients if it results in lengthy delays to essential care. The United States emphasizes individual autonomy, with each patient free to choose the treatment they believe is best for them. Society focuses on the needs and wants of individuals, which limits the government’s ability to control prices and creates access barriers for lower income individuals, de facto rationing on ability to pay. Neither result is desirable.

Breslau and colleagues reviewed 53 HTA guidelines to determine which of 21 societal and novel value elements they identified were included (average 5.9 elements per guideline). Only 4 value elements—productivity, family spillover, equity, and transportation—appeared in more than half the guidelines examined.⁷

Societies of European origin believe it is possible to control disease. Expressions like “I have cancer” or “my diabetes” implies ownership and therefore ability to manage the disease. As one patient with cancer said, “It has a name! We can fight it.” Other cultures see patients assuming a more passive role in illness. It is something that happens to them, something they can’t control. QALY use in Asia is challenged by nonallopathic medical systems whose practitioners do not perform randomized controlled trials, making it difficult to obtain clinical data required for QALY calculations. Swami and Srivastava described the role of culture, value, and politics in doing HTA in India, a country technologically advanced, but very different in culture from the West. Healthcare practices include traditional medicine, such as Ayurveda, homeopathy, Unani, yoga, and Siddha, along with allopathy. Home remedies are often used due to their low cost.⁸

“It appears that culture, values and institutional context shape attitudes of policy makers towards economic evaluation and HTA in general, and QALY in particular.” — Aleksandra Torbica, PhD

Culture is impacted by history. Alexis de Tocqueville, an astute early visitor to the United States, identified major differences: the vastness of the land, its isolation from the rest of the world, the absence of a system of landed aristocracy, the federal system of government, the power of an independent judiciary, and the “religious aspect of the country” but lack of a state religion.⁹ US immigrants were self-selected individuals who often risked their lives on the journey. They came for various reasons: escape from persecution or political disruptions, economic opportunity, adventure, and the promise of land ownership. They brought an optimistic self-reliance that the frontier forged into a culture of independence. Americans may eventually accept a national health system, but they will demand choice.

Pluralistic health systems are less likely to have a robust HTA process that uses QALYs. Private health systems have less well-defined budgets, and plurality reduces the contracting leverage of any one payer. US antitrust law prohibits payers from collaborating in price negotiations with manufacturers. The legal and regulatory framework can impact HTA by mandating coverage of particular treatments or restricting use of CEA to determine coverage. Private payers’ budgets are not subject to public scrutiny, and private for-profit payers must also consider stockholder interests. The ISPOR Working Group on HTA in Pluralistic Healthcare Systems offered 5 recommendations to address these specific challenges: establish a national focus for HTA, develop a uniform set of HTA methods guidelines, ensure that HTAs are produced in a timely fashion, facilitate the use of HTA in the local setting, and develop a framework to encourage transparency in HTA.¹⁰

Benefits and Uses

The QALY is a standard measure of the net health benefit derived from an intervention. It facilitates comparisons within and across disease states and treatment types. “QALYs represent time alive scaled to reflect health state desirability. Though they have some limitations, they are useful because they combine mortality and morbidity into a single metric, reflect individual preferences, and can be used as a standard measure of health gains across diverse treatments and settings,” explains Peter J. Neumann, ScD, Director of the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center, Boston, MA.¹¹ The QALY combines an objective clinical measure (years of life gained) with a subjective one (utility) based on individual values and preferences. The resulting estimates of cost per QALY gained can be used to compare different interventions, regardless of similarity. Users can compare an intervention to a specific threshold beyond which the intervention is considered to be of low value. Government and private payers can use QALY calculations when negotiating prices.

QALYs are not specific to healthcare and can be used to study tradeoffs with other investments that benefit the public, such as education, infrastructure, and social services, highlighting the marginal cost to society, which might otherwise be overlooked. Societal perspective is important in the United States, where there is relatively little public awareness of budget constraints and the marginal cost of tradeoffs may not be immediately apparent. For example, with employer-sponsored insurance, it is unlikely that the public will connect layoff of workers to rising insurance premiums when the market is simply responding to increased labor cost by replacing expensive employees with automation or outsourcing jobs to countries offering lower-cost workers.

Zeckhauser first proposed QALY calculations to inform societal allocation of scarce resources. The scope was broad, including “energy planning, national health insurance…occupational health and safety regulation, indeed national defense policy,” all of which affect both quantity and quality of life (QOL). “Disinterested citizens” argued over these matters primarily because they lacked information regarding consequences of proposed actions, rather than because they held different values. As an economist, Zeckhauser believed that more accurate predictions would focus arguments on issues that can be resolved and lead to effective action. “The guiding principle should be to select the measure(s) that would predict the choices that an informed individual would make for himself.”¹² Individuals would estimate the utility of each possible action, seeking to maximize utility. This principle is reflected in ISPOR’s mission to advance HEOR excellence to improve decision making for health globally.

“QALYs represent time alive scaled to reflect health state desirability. Though they have some limitations, they are useful because they combine mortality and morbidity into a single metric, reflect individual preferences, and can be used as a standard measure of health gains across diverse treatments and settings.” — Peter J. Neumann, ScD

Broad applicability is a major strength of QALY-based methods and an argument for their use. Highway accidents provide an example that directly impacts healthcare, since they can cause emergency medical treatment, permanent disability, reduced utility, and death. Interventions that reduce vehicle accident injuries would thus have a direct impact on life and the demand for medical care. A National Highway Traffic Safety Administration report illustrated the application of utilities in this field, helping policy makers appreciate marginal cost impacts across highway engineering and healthcare.¹³ The US Environmental Protection Agency has used QALYs to analyze the health impact of air pollution regulations,¹⁴ while the Centers for Disease Control and Prevention use them to analyze the cost-effectiveness of prevention interventions.¹⁵ The federal government makes use of QALYs in these areas but is prohibited from applying them to Medicare.

Criticisms

Despite these benefits, valid criticisms of QALY-based allocation decision making in healthcare and implementation challenges explain why so few countries have adopted formal CEA in coverage decision making. A fundamental objection is that health state utilities are population-based and not patient-centric. Patient advocates argue that QALYs discriminate against the elderly, disabled, and those with chronic life-limiting conditions. Utilities are based on the general public’s perceptions, measured by surveying uninvolved individuals who are well-informed about experience utility and have enough information about the health state to visualize a patient experiencing it. However, individual patient experiences vary widely and may not match the population-level valuation. Daniel Kahneman observed a discrepancy between self-evaluated utilities and those assigned by the stated preference-based methods used in the surveys. These valuations, he argued, are decision-based processes and fail to take into consideration the hedonic aspects of the patient’s experiences.¹⁶

Proponents counter that experienced utility-based methods do not require respondents to make a sacrifice. Since there is no opportunity cost, individuals respond as they would in an ideal state—we all want the best if it’s free. QALY-based methods offer no way to make a more nuanced evaluation of treatment impact on an individual’s health state. A patient’s value equation changes over time as they reach goals and set new ones. For patients with cancers, “the experience of living through the side effects of treatment changes the value as you go along,” says retired oncologist Richard McGee, MD.

Population estimates do not consider ethnic and demographic characteristics, occupation, and individual circumstances. For example, to return to work, an injured athlete, military member, or first responder must meet higher physical performance standards than most others who can still do their jobs despite reduced physical function. QALYs do not take this into consideration. Self-assessed utility varies across individuals, depending on their circumstances, life goals, and relationships. There is no one-size-fits-all. The Generalized Risk Adjusted Cost-Effectiveness (GRACE) method described below attempts to address this shortcoming of the QALY.

Age discrimination is a concern for patient advocates and pharmaceutical manufacturers. To address this question, Xie and colleagues analyzed 4445 studies from the Tufts CEA Registry published between 1976 and 2021. Of these, 661 (15%) were in populations over age 65. A comparison of ICERs between the 2 groups found “no systematic differences in published ICERs using QALYs.”¹⁷ However, it is still true that QALY calculations favor those most likely to benefit from treatment. While this may be the most efficient way to allocate scarce resources, there will be circumstances where it is less fair to individuals who can expect some, but not as much, benefit.

Patients and the public also react to the arbitrary nature of cost-utility thresholds, which in the United States currently range from $50,000 to $150,000 per QALY. These are proposed as coverage limits, but usually no satisfactory rationale for the specific numbers is given.* The concept of “willingness to pay” seems odd when those making the treatment decision (provider and patient) do not actually pay the cost, and the payer who does has no role in the decision. To an economist, these thresholds represent the value of the treatment in light of tradeoffs and marginal cost; to the budget holder, they represent limits designed to maintain affordability; to the patient, whose focus is on the need for care, they are a barrier to access. In the United States, most people react negatively to authorities telling them what to do.

Given these objections, it should be clear that the output of cost-effectiveness analysis is intended to guide population-level decisions about pricing and funding, not individual treatment decisions, which should be the result of shared decision making by provider and patient. Payers may use CEA to inform coverage policy, but these policies are always subject to individual case-based review, recognizing that every patient is unique and may have factors requiring an exception to the general policy.

Alternative Measures

Use of QALY-based decision making in federally funded programs is restricted by law in the United States. Section 504 of the Rehabilitation Act of 1973 “forbids organizations and employers from excluding or denying individuals with disabilities an equal opportunity to receive program benefits and services.”¹⁸ The Affordable Care Act adds language prohibiting “use of a cost-effectiveness analysis threshold and QALYs in PCORI comparative effectiveness studies, which has been understood as a prohibition on support for PCORI’s conducting conventional cost-effectiveness analyses.”¹⁹

The Inflation Reduction Act authorizing Medicare to negotiate drug prices states that the Department of Health and Human Services  Secretary “shall not use evidence from comparative clinical effectiveness research in a manner that treats extending the life of an elderly, disabled, or terminally ill individual as of lower value than extending the life of an individual who is younger, nondisabled, or not terminally ill.” In other words, the use of health outcomes evidence based on QALYs in the process of negotiating a maximum fair price is not permitted.²⁰ In 2023, HR-485, the Protecting Health Care for All Patients Act, which would have banned use of the QALY “and other similar measures” in decision making for federally funded programs, was passed by the House but failed in the Senate.²¹ With Republicans in charge, a similar bill may be introduced when Congress convenes in January. The language (“other similar measures”) is vague and subject to interpretation.

To address this barrier, ICER now reports cost-utility ratios from both equal value of life years (EVLY) gained and QALY calculations. The EVLY, as defined by ICER and labeled evLYG in their publications, assigns a “healthy population” level utility of 0.85 to any additional life years achieved by the intervention. The evLYG measures QOL improvements or decrements versus the comparator during the rest of the lifespan, but any extended life receives the same weight, no matter the underlying utility. This avoids discrimination against the elderly, disabled, or terminally ill. ICER analyses generally show only a modest difference between QALY and evLYG results because most drugs ICER reviews extend life modestly at best; however, this will not be true for gene therapies and other drugs expected to extend survival. Lacking evidence from long-term follow-up, both QALY and evLYG lifetime gains are hypothetical at this point. Otherwise, the evLYG is subject to the same criticisms as the QALY, and it fails to capture treatment benefit that improves utility without extending survival.

Health years in total (HYT) is another QALY alternative measure proposed by Basu, Carlson, and Veenstra in 2020. This new measure uses the same inputs but differs from the QALY in that “the HYT framework separates life expectancy changes and QOL changes on an additive scale.” Rather than the multiplicative combination in the traditional QALY, HYT have the same axiomatic foundations as QALY and perform better than both QALY, in terms of the discriminatory implications, and EVLY, in terms of capturing QOL gains during added years of life. HYT are straightforward to calculate within a CEA model.²² The authors hope that the HYT will be more readily accepted in the United States: “The lack of separability in QALY imparts its discriminatory property,” Basu points out. However, given the trend toward broader US legal restriction, the HYT may yet face challenges. Neither EVLY nor HYT solve the challenge of achieving distributional equity.

Following the ISPOR Task Force Report, a new approach, GRACE, which helps align HTA practice with realistic preferences for health and risk, was proposed by Lakdawalla and Phelps in 2020.²³ “The disability community has pointed out mathematical limitations of the QALY,” explains Lou Garrison, PhD, Professor Emeritus at the University of Washington, Seattle, WA, and Special Task Force co-leader. “We don’t have a universal exchange rate between quality and quantity of life, such that a certain percentage increase in quality of life is equivalent to so many life years for everyone. Obviously, every individual has his/her own exchange rate, but people aren’t voting with their own dollars in the health economy. So we don’t have unfettered market transactions to measure this value. But, given information on disease probability, QALY loss, and other costs, and given the value that a patient places on a year of healthy life, conventional CEA predicts what that patient should be willing to pay in insurance premiums or taxes. That’s the intuition behind conventional CEA, but the mathematics and the methodology are limited since conventional CEA doesn’t fully capture the value of reducing uncertainty.

“In my view, perhaps the most important part of GRACE is what we could call ‘mental insurance value’— the peace of mind you get from knowing something can be done about your health condition. For example, in November 2019, before COVID, if asked, you might have said you were feeling pretty good. Then in March of 2020 you were told you might die by June and there might be nothing we could do about it: your utility fell. But when we learned that the mRNA platform could produce a vaccine in 9 months, utility levels went up for billions of people.” That peace of mind is what GRACE captures, Garrison says. It’s also an example of scientific spillover, another important value element—since that the new mRNA platform can be applied to produce other vaccines.

“We don’t have unfettered market transactions to measure this value. But, given the value that a patient places on a year of healthy life, conventional CEA predicts what that patient should be willing to pay in insurance premiums or taxes.” — Lou Garrison, PhD

“I think it’s situated in the broader project of building a microeconomic foundation for cost-effectiveness analysis,” Darius Lakdawalla, PhD, Professor of Pharmaceutical Development and Regulatory Innovation at the University of Southern California, Los Angeles, CA, explained. “GRACE attempts to generalize those foundations and give analysts more choice by looking at how the structure of preferences and the shape of the utility over health impacts and influences the implications of cost-effectiveness analysis. And so, it’s our hope that it can be useful. It actually gives you a way to perform cost-effectiveness that aligns with US law because there are well-fitting utility functions that correspond to nondiscriminatory cost-effectiveness, which is required now under the IRA [Inflation Reduction Act] and the ACA [Affordable Care Act]. The ISPOR value flower showed us a number of empirical anomalies that needed explanation, and GRACE shows you how the shape of preferences can help unlock some of these anomalies. When you have a more explicit approach to thinking about utility, it also provides a means to update the measurement of preferences with more modern methods, so you can use prospect [aversion to loss] theory and quantifying and implementing cost-effectiveness analysis in the framework of GRACE.”²⁴

GRACE attempts to modify traditional CEA to incorporate other dimensions of value. It is a work in progress within the broader space of generalized CEA, which was recently reviewed by Padula and Kolchinsky, who suggest that with further development we could have “off-the-shelf” resources to help inform, for example, maximum fair price in the context of Medicare drug price negotiation. Additional novel value elements could be incorporated.²⁵ Generalized CEA can potentially help in distributional cost-effectiveness analysis. The QALY is agnostic to an individual’s socioeconomic status or vulnerability, and in some situations might actually favor the wealthier individual. GRACE provides some flexibility to support distributive justice and allow future researchers to better align with what consumers want.

“The ISPOR value flower showed us a number of empirical anomalies that needed explanation, and GRACE shows you how the shape of preferences can help unlock some of these anomalies.” — Darius Lakdawalla, PhD

Unanswered Questions

This summary of the QALY leaves many questions unanswered. What is the underlying purpose of healthcare versus health insurance? How should it be funded? From whose perspective should resources be allocated, and how can we make decisions for a public that does not share a common worldview?

When offered truly lifesaving innovations, how much should we be “willing to pay?” What percentage of gross domestic product is the practical upper limit of the healthcare “budget” we can afford? How do we balance long- versus short-term perspectives?

How societies answer these questions will determine the future of CEA and the QALY. What role should ISPOR and its members play in guiding this conversation to find solutions? There is no single “right” answer. Each country or region must find its own way. However, there is wisdom in a multitude of counselors. ISPOR can provide a venue where diversity and honest discussion are encouraged and we learn from the ideas of others.

* The $50,000/QALY threshold used in the United States was originally based on the cost of maintaining a renal dialysis patient. No convincing argument for these numbers has ever been offered.

References

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