Congress Considers Banning The QALY

In late March, the House Committee on Energy and Commerce advanced H.R. 485 – Protecting Health Care for All Patients Act – on a party line vote with Republicans favoring an amended version of the bill which aims to block the ability of entities in the public and private sectors to use comparative effectiveness research measures to assess the value of medications for patients.

H.R. 485 specifically seeks to prohibit the use of quality adjusted life years (QALYs) in all federal programs. This would represent an expansion from the current prohibition that only applies in a limited way to the Medicare program.

Congresswoman Cathy McMorris Rodgers (R-WA) is a staunch critic of QALYs. On her government website she writes: “All lives are worth living. It’s unconscionable that a healthcare bureaucracy would so callously determine that someone’s life is worth less. They deserve every chance to have hope and reach their full potential. The ‘quality-adjusted life years’ measurement is used to discriminate against people with chronic illnesses and disabilities, like cystic fibrosis, ALS, or Down syndrome, putting them at the back of the line for treatment.”

Of course, this isn’t the first time QALYs have been bashed. In Britain, there was a lively, substantive debate on QALYs in the late 1980s and early 1990s. As just one example of a respected scholar who offered contrarian views, John Harris published dozens of peer-reviewed articles on the topic, while some of the British titans of health economics, like Alan Williams, vigorously defended the QALY.

As a PhD student, I even participated in the QALY discussion, albeit in a very modest way. Then, I was sympathetic with critics of the QALY. I still am to some degree. And while I’m critical of the use of incremental cost-per-QALY ratios to compare treatments, particularly when we examine diseases that are qualitatively very different, I’m of the belief that we should be constructive in our criticism. And, I’m totally opposed to bans on concepts like the QALY.

In lieu of an alternative better method to allocate healthcare in circumstances of finite resources, we still need a way to measure the value of medical interventions. And the QALY itself is rather innocuous. As a composite of the two most important aspects of health benefits – extension of life and quality of life improvement – the QALY serves as a decent, albeit far from perfect, proxy of value.

The QALY is simply a concept, and a flexible one at that, meaning it can accommodate some of the issues cited by critics, including being able to account for severity of disease. To illustrate, there are ways to adjust the QALY with weights for disease burden, among other things. Alternatively, there’s a method that can be employed to place the same value on additional years of life across diseases and populations. This is something the equal value life-year gained (evLYG) can accomplish.

The QALY can be used in comparative cost-effectiveness research to inform decisions about maximizing people’s health given limited budgets, because this measure allows for comparison of health gains across treatments and diseases.

Granted, this is a utilitarian exercise, and not all of us are utilitarians. Yet, many governments around the world have implicitly adopted a utilitarian mindset, in part to achieve the most health at the population level, subject to inevitable budgetary limits.

This is not to say that government or private entities ought to adopt a utilitarian perspective, or must incorporate the QALY in their healthcare evaluations. The German health authorities, for example, mostly eschew use of the QALY in favor of an efficiency frontier approach. The latter still has utilitarian overtones, but avoids some of the thornier concerns about the QALY.

When critics discuss bans of QALYs, implicitly their main target is use of an incremental cost-per-QALY threshold to determine reimbursement of medical interventions. Here, the threshold – rather than the QALY itself – has been the subject of serious discussion in policy circles for a long time.

For decades, there’s been criticism, for instance, of the arbitrariness of the numeric level of cost-effectiveness thresholds that agencies have adopted. In Britain, the threshold value is £30,000. It’s been stuck at that level since 1999, which, frankly, doesn’t seem right. A lot has changed in the past 24 years. Surely, the cost-effectiveness threshold level should have been revised.

Ultimately, a threshold ought to reflect the opportunity cost in the health care system, that is, the displaced benefits forgone. But it’s rare that we see actual empirical estimates of the threshold.

The QALY isn’t perfect, but no measure is. And let’s be frank, we’ll never have a measure that makes everyone happy. To ban the concept is to throw the baby out with the bath water.

As David Mitchell of Patients for Affordable Drugs writes: “It is axiomatic that to stimulate and reward innovative new drug development, we should pay more for high value drugs and less for low value drugs.” In order to do this effectively, we need evidence based on comparative effectiveness research. And this can involve the QALY.

Healthcare policymakers must make decisions every day. Preferably their decisions are informed explicitly by robust evidence. That’s certainly preferable to uninformed decision-making. One can’t spend the same healthcare dollar twice. There is therefore a societal imperative for policymakers to make each dollar go as far as it can in terms of producing health outcomes for the population as a whole.

Importantly in this context, analyses using QALYs are just one input in pricing, reimbursement, and allocation decisions. Policymakers, insurers, and other interested parties also consider other inputs, such as the availability of alternative therapies and benefits and risks of care that are not easily quantified.

If policymakers are prevented from using incremental cost-per-QALY analyses to inform decisions – or even just the QALY itself as a metric – then there better be an alternative in mind that’s workable and can be operationalized. Otherwise we’re deluding ourselves into thinking we can avoid hard choices. The only way we’ve avoided hard choices in the U.S. is by implicit rationing that is often random, not evidence-based, and usually inequitable.