Alternatives to the QALY for Comparative Effectiveness Research

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The QALY is an important outcome measure used by many cost-effectiveness researchers, yet also represents a tool for making comparative effectiveness assessments of interventions that address the health needs of populations. When used for HTA and CEA evaluation, the sum of the comparative QALY measure produced by a new health intervention is agnostic to whom the QALYs accrue. There is concern by some that the QALY discriminates against elderly, disabled or terminally ill Americans. While not a perfect measure, valid alternatives exist that address these concerns and allow explicit consideration of both quality and length of life in comparative effectiveness assessments.

While the QALY remains controversial, placing value on both life extension and quality of life should not be. Interventions that improve patient quality of life without extending life are essential for countless patients with chronic diseases. For example, many of the FDA-approved pharmaceutical treatments for patients with chronic obstructive pulmonary disease and emphysema improve symptoms and lung function and also reduce burdensome and expensive disease exacerbations. The impact that these interventions have on well-being and quality of life is substantial and important to patients and their families. Yet, there is no direct evidence that these treatments improve life expectancy. There also are disease states where patients face difficult treatment decisions that require tradeoffs between quality of life and length of life, such as in cancer. Failing to consider and value improvements in quality of life might penalize treatments in coverage and payment determinations and may limit access for patients suffering from poor quality of life.

HEOR scientists, including Curta Partners, have created alternatives to the QALY that retain the ability to assess and value well-being and quality of life without discriminating against any members of society. The equal value of Life Years Gained (evLYG), Health Years in Total (HYT) and the Generalized Risk Adjusted QALY (GRA-QALY) method are important advances in the fields of population health measurement and cost-effectiveness research. In the National Disability Council’s report on “Alternatives to QALY-Based Cost-Effectiveness Analysis for Determining the Value of Prescription Drugs and Other Health Interventions,” they write that the evLYG, “eliminates the risk of undervaluing life-extension for people with disabilities,” and that, “disability rights advocates have described HYT as a better approach to standard CEA because it removes the devaluation of life extension of people with disabilities.”

Health care authorities in other countries (Australia, Canada, France, Germany, Japan, Netherlands, Sweden, and the UK to name a few) use the outcomes of comparative effectiveness research, including improvements in both life expectancy and quality of life (such as that summarized in the QALY), to inform their population health care funding decisions. They do so because they understand that resource allocation decisions can have positive and negative effects on population health. The full range of comparative effectiveness evidence on treatments is useful, equitable, and necessary for the efficient use of scarce health sector resources.

We now have useful and valid alternatives that allow for the assessment and valuation of treatments that improve population health without discriminating against vulnerable patient populations. Indeed, these new measurement approaches can even promote health equity by recognizing the additional value of improving health outcomes for vulnerable populations. Many Americans continue to suffer the burden of poor quality of life. Congress should ensure that federal and state agencies that incorporate comparative effectiveness research into decision making, such as CMS, can explicitly recognize the value of reducing this burden to improve patient outcomes by acknowledging valid measures that incorporate life extension and quality of life without discrimination.

To access the full publication, visit:

https://www.healthaffairs.org/content/forefront/alternatives-qaly-comparative-effectiveness-research