Value Assessments: Are We There Yet?
In a value-driven healthcare system, value assessments can be used as a tool to evaluate and measure the value of healthcare interventions, treatments, and services. In this issue of Value & Outcomes Spotlight, the feature article by John Watkins, PharmD, MPH, BCPS, provides an excellent and comprehensive overview of the quality-adjusted life-year (QALY) and covers both strengths and weaknesses of the traditional QALY approach as well as the proposed enhancements being applied. I have highlighted some of the key insights below.
The Role of QALYs in Healthcare Decision Making
Over the past 5 decades, the QALY has served as a key metric in cost-effectiveness analysis within healthcare. It provides a standardized approach for evaluating the benefits of medical interventions by comparing the years of life that would be added by the intervention, adjusted for the quality of those years. The QALY seeks to quantify health outcomes by integrating both the quantity and quality of life into a singular measure, facilitating comparisons across diverse medical treatments and conditions. This capability allows payers, policy makers, and clinicians to make more informed decisions regarding the allocation of limited healthcare resources.
Torbica and colleagues highlighted that the use of QALYs in formal decisions mainly occurs in Europe where there is extensive use in some countries like the United Kingdom. France and Germany are different from the rest of Europe as they do not formally use QALYs. Instead, they rely on evidence of incremental net clinical benefit to score a new drug and use these ratings in price negotiations with manufacturers. However, in cases where a manufacturer claims its drug is innovative, France may request cost per QALY studies. In Germany, an economic evaluation can be conducted if there is no agreement on price in the first year the drug is on the market.
Conversely, there are countries that are low utilizers (ie, the United States) where the use of QALYs is less prominent in formal decision making due to regulatory constraints and the nation’s emphasis on individual autonomy. The US experience underscores significant historical, cultural, and institutional variations impacting QALY adoption and points to factors such as social values and administrative traditions influencing the use of economic evaluation in healthcare.
"The QALY seeks to quantify health outcomes by integrating both the quantity and quality of life into a singular measure, facilitating comparisons across diverse medical treatments and conditions."
Facing the Criticisms and Limitations
Despite its utility and benefits of broad applicability to compare across treatments and interventions, the QALY framework is not without criticism. Critics argue that the QALY has limitations of not being patient-centric, which can lead to potential discrimination against certain patient populations such as older adults, individuals with disabilities, and those with chronic life-limiting conditions and rare diseases. By relying on average population perceptions, the QALY might devalue specific lives by not accurately capturing individual patient experiences, which can undermine the sensitivity of QALYs to personalized healthcare needs. Furthermore, the use of QALY thresholds in decision making, such as coverage limits in healthcare, introduces potential barriers to access. This raises ethical concerns about equity, as value thresholds do not always reflect the nuanced realities of individual health priorities and societal willingness to pay for healthcare advancements. For these reasons, QALYs should not be used in making individual patient-level decisions.
Exploring Alternative Measures
In response to these challenges, alternative metrics have emerged. The Equal Value of Life Years Gained (EVLY) and Health Years in Total (HYT) attempt to address some discriminatory limitations inherent in QALYs. EVLY assigns equal weight to life-years gained, irrespective of underlying health state, aiming to reduce age and disability bias. HYT separates changes in quality of life and life expectancy, which enhances the discrimination implications and aligns with additive health outcomes. Additionally, the Generalized Risk-Adjusted Cost-Effectiveness (GRACE) framework seeks to address the broader impacts and preferences related to health interventions, incorporating dimensions like “mental insurance value” and potential peace of mind derived from available treatments.
"As health systems around the world grapple with rising costs and increasing healthcare demands, the role of QALYs as a measurement tool will undeniably evolve."
The Future Outlook on QALYs
As we reflect on decades of QALY usage, we must examine its achievements and limitations and consider what the future holds for this influential tool in assessing health outcomes. As health systems around the world grapple with rising costs and increasing healthcare demands, the role of QALYs as a measurement tool will undeniably evolve.
For some countries, particularly those with pluralistic health systems like the United States, formal adoption of QALYs in policy remains complex. However, there is significant value in considering QALYs as part of a multifaceted toolkit for healthcare decision making.
The future of QALYs may lie in its ability to adapt and integrate new dimensions of value that reflect both individual and societal health priorities. Organizations such as ISPOR are instrumental in fostering these discussions. The ISPOR “value flower” seeks to expand beyond traditional QALYs by incorporating holistic perspectives, potentially aligning metrics like QALYs with legal and regulatory requirements while addressing criticisms of bias and lack of individual customization.
Ultimately, the legacy and future of QALYs hinge on distinctive approaches encompassing multiple viewpoints, aiming to reflect diverse healthcare values. As each region tailors its use of cost-effectiveness measures, ISPOR and similar entities provide a platform for exchanging ideas and encouraging international collaboration to enrich health outcomes measurement. Through adaptive methodologies, like GRACE and others, QALYs are poised to stand the test of time, offering valuable insights into the optimal allocation of scarce healthcare resources across the globe.
So back to the question on value assessments—are we there yet? No, we’re not there yet, but I’m confident that we will keep moving toward the eventual goal of reflecting value in the richest, most nuanced way possible.
As always, I welcome input from our readers. Please feel free to email me at zeba.m.khan@hotmail.com.
Zeba M. Khan, RPh, PhD
Editor-in-Chief, Value & Outcomes Spotlight
