Are QALYs #ableist?

As many of us who have had to review submitted journal articles, thesis defenses, grant applications, white papers, and even published literature know, providing feedback on something that is poorly conceived is much harder than providing feedback on something well done.

This is going to be hard.

Who is ValueOurHealth?

The video above comes from the website of “ValueOurHealth.org”; I would tell you more about them, but there is no “About Us” menu item on the website. However, the website indicates that they are a group of patient organizations concerned about:

“The use of flawed, discriminatory value assessments [that] could threaten access to care for patients with chronic illnesses and people with disabilities.”

In particular, who find issue with value assessments that

“place a value on the life of a human based on their health status and assume every patient will respond the same way to treatments.”

QALYs, according to these concerned patient groups, assign a value to human beings. People with lower values (like Jessica, in the video above), then, will be denied coverage because their life is “valued less than someone in perfect health” which means “less value is also placed on treating” them. (Many will be quick to notice that health states and QALYs are used interchangeably here. I try to explain why below.)

It’s not like this is a well-intended rogue group who simply misunderstands the concept of a QALY, requires someone to send them a polite email, and then we can all move on. Other groups have also asserted that QALYs unfairly discriminate against the aged and disabled, and include AimedAlliance, Alliance for Patient Access, Institute for Patient Access, Alliance for Aging Research, and Global Liver Institute. There are likely many more patient groups that abhor QALYs (and definite articles/determiners, it seems) out there, and are justifiably concerned about patient access to therapy. But these are all the ones I could find through a quick search and sitting from my perch in Canada.

Why do they hate QALYs?

One can infer pretty quickly that ValueOurHealth and their illustrative message is largely motivated by another very active organization, the “Partnership to Improve Patient Care” (PIPC). The video, and the arguments about “assigning QALYs” to people, seem to stem from a white paper produced by the PIPC, which in turn cites a very nicely written paper by Franco Sassi (of Imperial College London), that explains QALY and DALY calculations for researchers and policymakers.

The PIPC white paper, in fact, uses the very same calculation provided by Prof. Sassi to illustrate the impact of preventing a case of tuberculosis. However, unlike Prof. Sassi’s illustrative example, the PIPC fails to quantify the QALYs gained by the intervention. Instead they simply focus on the QALYs an individual who has tuberculosis for 6 months will experience. (0.36, versus 0.50, for those keeping score). After some further discussion about problems with measuring health states, the PIPC white paper then skips ahead to ethical problems with QALYs central to their position, citing a Value in Health paper by Erik Nord and colleagues. One of the key problems with the QALY according to the PIPC and argued in the Nord paper goes as follows:

“Valuing health gains in terms of QALYs means that life-years gained in full health—through, for instance, prevention of fatal accidents in people in normal health—are counted as more valuable than life-years gained by those who are chronically ill or disabled—for instance, by averting fatal episodes in people with asthma, heart disease, or mental illness.”

It seems the PIPC assume the lower number of QALYs experienced by those who are sick equates with the value of lives to payers. Even more interestingly, Prof. Nord’s analysis says nothing about costs. While those who are older have fewer QALYs to potentially gain, they also incur fewer costs. This is why, contrary to the assertion of preventing accidents in healthy people, preventive measures may offer a similar value to treatments when both QALYS and costs are considered.

It is also why an ICER review showed that alemtuzumab is good value in individuals requiring second-line treatment for relapse-remitting multiple sclerosis (1.34 QALYs can be gained compared to the next best alternative and at a lower cost then comparators), while a policy of annual mammography screening of similarly aged (i.e., >40) healthy women is of poor economic value (0.036 QALYs can be gained compared to no screening at an additional cost of $5,500 for every woman). Mammography provides better value in older individuals. It is not unlike fracture prevention and a myriad of other interventions in healthy, asymptomatic people in this regard. Quite contrary to the assertion of these misinformed groups, many interventions represent increasingly better value in frail, disabled, and older patients. Relative risks create larger yields when baseline risks are high.

None of this is to say that QALYs (and incremental cost-effectiveness ratios) do not have problems. And the PIPC, at the very least, should be commended for trying to advance alternative metrics, something that very few critics have offered. Instead, the PIPC and like-minded organizations are likely trapped in a filter bubble. They know there are problems with QALYs, and they see expensive and rare disease treatments being valued harshly. So, ergo, blame the QALY. (Note to PIPC: it is because the drugs are expensive, relative to other life-saving things, not because of your concerns about the QALY.) They then see that others feel the same way, which means their concerns are likely justified. A critique of QALYs issued by the Pioneer Institute identifies many of these same arguments. One Twitterer, a disabled Massachusetts lawyer “alive because of Medicaid” has offered further instruction for the QALY-naive.

What to do about it?

As a friend recently told me, not everyone is concerned with the QALY. Some don’t like what they see as a rationing approach promoted by the Institute for Clinical and Economic Review (ICER) assessments. Some hate the QALY. Some hate both. Last year, Joshua T. Cohen, Dan Ollendorf, and Peter Neumann published their own blog entry on the effervescing criticism of ICER, even allowing the PIPC head to have a say about QALYs. They then tried to set the record straight with these thoughts:

While we applaud the call for novel measures and to work with patient and disability advocates to understand attributes important to them, there are three problems with PIPC’s position.

First, simply coming up with that list of key attributes does not address how society should allocate finite resources, or how to price a drug given individual or group preferences.

Second, the diminished weight QALYs assign to life with disability does not represent discrimination. Instead, diminished weight represents recognition that treatments mitigating disability confer value by restoring quality of life to levels typical among most of the population.

Finally, all value measures that inform allocation of finite resources trade off benefits important to some patients against benefits potentially important to others. PIPC itself notes that life years not weighted for disability (e.g., the equal value life-year gained, or evLYG, introduced by ICER for sensitivity analysis purposes) do not award value for improved quality of life. Indeed, any measure that does not “discriminate” against patients with disability cannot award treatments credit for improving their quality of life. Failing to award that credit would adversely affect this population by ruling out spending on such improvements.

Certainly a lot more can be said here.

But for now, I am more curious what others have to say…

Chris Sampson’s journal round-up for 27th August 2018

Every Monday our authors provide a round-up of some of the most recently published peer reviewed articles from the field. We don’t cover everything, or even what’s most important – just a few papers that have interested the author. Visit our Resources page for links to more journals or follow the HealthEconBot. If you’d like to write one of our weekly journal round-ups, get in touch.

Ethically acceptable compensation for living donations of organs, tissues, and cells: an unexploited potential? Applied Health Economics and Health Policy [PubMed] Published 25th August 2018

Around the world, there are shortages of organs for transplantation. In economics, the debate around the need to increase organ donation can be frustratingly ignorant of ethical and distributional concerns. So it’s refreshing to see this article attempting to square concerns about efficiency and equity. The authors do so by using a ‘spheres of justice’ framework. This is the idea that different social goods should be distributed according to different principles. So, while we might be happy for brocolli and iPhones to be distributed on the basis of free exchange, we might want health to be distributed on the basis of need. The argument can be extended to state that – for a just situation to prevail – certain exchanges between these spheres of justice (e.g. health for iPhones) should never take place. This idea might explain why – as the authors demonstrate with a review of European countries – policy tends not to allow monetary compensation for organ donation.

The paper cleverly sets out to taxonomise monetary and non-monetary reimbursement and compensation with reference to individuals’ incentives and the spheres of justice principles. From this, the authors reach two key conclusions. Firstly, that (monetary) reimbursement of donors’ expenses (e.g. travel costs or lost earnings) is ethically sound as this does not constitute an incentive to donate but rather removes existing disincentives. Secondly, that non-monetary compensation could be deemed ethical.

Three possible forms of non-monetary compensation are discussed: i) prioritisation, ii) free access, and iii) non-health care-related benefits. The first could involve being given priority for receiving organs, or it could extend to the jumping of other health care waiting lists. I think this is more problematic than the authors let on because it asserts that health care should – at least in part – be distributed according to desert rather than need. The second option – free access – could mean access to health care that people would otherwise have to pay for. The third option could involve access to other social goods such as education or housing.

This is an interesting article and an enjoyable read, but I don’t think it provides a complete solution. Maybe I’m just too much of a Marxist, but I think that this – as all other proposals – fails to distribute from each according to ability. That is, we’d still expect non-monetary compensation to incentivise poorer (and on average less healthy) people to donate organs, thus exacerbating health inequality. This is because i) poorer people are more likely to need the non-monetary benefits and ii) we live in a capitalist society in which there is almost nothing that money can’t by and which is strictly non-monetary. Show me a proposal that increases donation rates from those who can most afford to donate them (i.e. the rich and healthy).

Selecting bolt-on dimensions for the EQ-5D: examining their contribution to health-related quality of life. Value in Health Published 18th August 2018

Measures such as the EQ-5D are used to describe health-related quality of life as completely and generically as possible. But there is a trade-off between completeness and the length of the questionnaire. Necessarily, there are parts of the evaluative space that measures will not capture because they are a simplification. If the bit they’re missing is important to your patient group, that’s a problem. You might fancy a bolt-on. But how do we decide which areas of the evaluative space should be more completely included in the measure? Which bolt-ons should be used? This paper seeks to provide means of answering these questions.

The article builds on an earlier piece of work that was included in an earlier journal round-up. In the previous paper, the authors used factor analysis to identify candidate bolt-ons. The goal of this paper is to outline an approach for specifying which of these candidates ought to be used. Using data from the Multi-Instrument Comparison study, the authors fit linear regressions to see how well 37 candidate bolt-on items explain differences in health-related quality of life. The 37 items correspond to six different domains: energy/vitality, satisfaction, relationships, hearing, vision, and speech. In a second test, the authors explored whether the bolt-on candidates could explain differences in health-related quality of life associated with six chronic conditions. Health-related quality of life is defined according to a visual analogue scale, which notably does not correspond to that used in the EQ-5D but rather uses a broader measure of physical, mental, and social health.

The results suggest that items related to energy/vitality, relationships, and satisfaction explained a significant part of health-related quality of life on top of the existing EQ-5D dimensions. The implication is that these could be good candidates for bolt-ons. The analysis of the different conditions was less clear.

For me, there’s a fundamental problem with this study. It moves the goals posts. Bolt-ons are about improving the extent to which a measure can more accurately represent the evaluative space that it is designed to characterise. In this study, the authors use a broader definition of health-related quality of life that – as far as I can tell – the EQ-5D is not designed to capture. We’re not dealing with bolt-ons, we’re dealing with extensions to facilitate expansions to the evaluative space. Nevertheless, the method could prove useful if combined with a more thorough consideration of the evaluative space.

Sources of health financing and health outcomes: a panel data analysis. Health Economics [PubMed] [RePEc] Published 15th August 2018

There is a growing body of research looking at the impact that health (care) spending has on health outcomes. Usually, these studies don’t explicitly look at who is doing the spending. In this study, the author distinguishes between public and private spending and attempts to identify which type of spending (if either) results in greater health improvements.

The author uses data from the World Bank’s World Development Indicators for 1995-2014. Life expectancy at birth is adopted as the primary health outcome and the key expenditure variables are health expenditure as a share of GDP and private health expenditure as a share of total health expenditure. Controlling for a variety of other variables, including some determinants of health such as income and access to an improved water source, a triple difference analysis is described. The triple difference estimator corresponds to the difference in health outcomes arising from i) differences in the private expenditure level, given ii) differences in total expenditure, over iii) time.

The key finding from the study is that, on average, private expenditure is more effective in increasing life expectancy at birth than public expenditure. The author also looks at government effectiveness, which proves crucial. The finding in favour of private expenditure entirely disappears when only countries with effective government are considered. There is some evidence that public expenditure is more effective in these countries, and this is something that future research should investigate further. For countries with ineffective governments, the implication is that policy should be directed towards increasing overall health care expenditure by increasing private expenditure.

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Paul Mitchell’s journal round-up for 1st January 2018

Every Monday our authors provide a round-up of some of the most recently published peer reviewed articles from the field. We don’t cover everything, or even what’s most important – just a few papers that have interested the author. Visit our Resources page for links to more journals or follow the HealthEconBot. If you’d like to write one of our weekly journal round-ups, get in touch.

Does the approach to economic evaluation in health care depend on culture, values and institutional context? European Journal of Health Economics [PubMedPublished 5th December 2017

In last week’s round-up we looked at a paper that attempted to develop guidance for costing across European economic evaluations, even when the guidelines across countries vary as to what should and should not be included in an economic evaluation. Why is it that there is such variation in health economic evaluation methods across countries? Why are economic outcomes like quality-adjusted life years (QALYs) standard practice in some countries yet frowned upon in others? This editorial argues that cultures, values and institutional context play a role in the economic evaluation methodologies applied across countries. It does so by comparing five large European countries in terms of 1. the organisation and governance of the agencies undertaking health technology assessments (HTAs) and economic evaluation, 2. the methods used for economic evaluation, and 3. the use of HTA and economic evaluation in decision making. The authors argue that due to differences in these areas across countries, it is difficult to see how a “one size fits all” economic evaluation framework can be implemented, when health care systems, their regulations and social values towards health care differ. An argument is presented that where greater social value is placed on horizontal equity (equal treatment of equals) over vertical equity (unequal treatment of unequals), the QALY outcome is more likely to be applied in such countries. They argue that of the five largest European countries, the German efficiency frontier model of economic analysis may offer the best off-the-shelf option for countries like the United States who also have similar qualms about the use of QALYs in decision making. However, it may be the case that current economic evaluations lack international application due to other reasons beyond those notable considerations raised in this paper.

Reconciling ethical and economic conceptions of value in health policy using the capabilities approach: a qualitative investigation of Non-Invasive Prenatal Testing. Social Science & Medicine [PubMed] [RePEcPublished 16th November 2017

The capability approach, initially developed by economist and philosopher Amartya Sen, provides an alternative evaluative framework to welfare economics, shifting the focus on individual welfare away from utility and preferences, towards a person’s freedom to do and be valuable things to their life. It has more recently been used as a critique of the current approach to health economic evaluations, specifically what aspects of quality of life are included in the economic outcome, where the current measurement tools used in the generation of QALYs have been argued to have too narrow a focus on health outcomes, with a number of capability measures now developed as alternatives. This study, on the other hand, applies the capability approach to tackle health technologies that pose difficult ethical challenges where standard clinical and economic outcomes used in cost-effectiveness analysis may be in conflict with social values. The authors propose why they think the evaluative framework of the capability approach may be advantageous in such areas, using non-invasive prenatal testing (NIPT), a screening test that analyses cell-free fetal DNA circulating in maternal blood in order to gain information about the fetal genotype, as a case study. The authors propose that adopting a capability evaluative framework in NIPT may account for the enhancement of valuable options available to prospective parents and families, as well as capabilities that may be diminished if NIPT was made routinely available, such as the option of refusing a test as an informed choice. A secondary analysis of qualitative data was conducted on women with experience of NIPT in Canada. Using a constructivist orientation to directed qualitative content analysis, interviews were analysed to see how NIPT related to a pre-existing list of ten Central Human Capabilities developed by philosopher Martha Nussbaum. From the analysis, they found eight of the ten Nussbaum capabilities emerge from the interviewees who were not directly asked to consider capability in the interview. As well as these eight (life; bodily health; bodily integrity; senses, imagination and thought; emotions; practical reason; affiliation; control over one’s environment), a new capability emerged related to care-taking as a result of NIPT, both for potential children and also the impact on existing children. The next challenge for the authors will be trying to formulate their findings into a usable outcome measure for decision-making. However, the analysis undertaken here is a good example of how economists can attempt to tackle the assessment of ethically challenging technologies as a way of dealing with standard economic outcomes that might be considered counter-productive in such evaluations.

Quality of life in a broader perspective: does ASCOT reflect the capability approach? Quality of Life Research [PubMedPublished 14th December 2017

The Adult Social Care Outcomes Toolkit (ASCOT) is a measure developed specifically for the economic assessment of social care interventions in the UK. Although a number of versions of ASCOT have been developed, the most recent version of ASCOT has been argued to be a measure influenced by the capability approach, even though previous versions of the measure were not justified similarly, so it remains to be seen how influential the capability approach is in the composition of this outcome measure. This study attempts to add justification of linking the capability approach with the ASCOT by conducting a literature review on the capability approach to identify key issues of quality of life measurement and how ASCOT deals with these issues. The methods for conducting the literature review are not described in detail in this paper, but the authors state that three primary issues with quality of life measurement in the capability approach literature that emerge from their review are concerned with 1. the measurement of capability, 2. non-reliance on adaptive preferences, and 3. focus on a multidimensional evaluative space. The authors argue that capability measurement is tackled by ASCOT, through the use of “as I want” phraseology at the top level on the ASCOT dimensions. Adaptive preferences are argued to be tackled by the use of general population preferences of different states on ASCOT and the outcome addresses several dimensions of quality of life. I would argue that there is much more to measuring capability beyond these three areas identified by the authors. Although the authors rightly question if the “as I want” phraseology is adequate to measure capability in their conclusion, the other two criteria could equally justify most measures for generating QALYs, so the criteria they use to be a capability measure is set at a very low benchmark. I remain unconvinced about how much of a capability measure ASCOT actually is in practice.

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