This document discusses challenges associated with going beyond health-related quality of life measures in cost-utility analysis. It notes that while economic evaluations often use quality-adjusted life years (QALYs) based on health-related quality of life instruments like EQ-5D, interventions can provide benefits beyond health alone. There are theoretical, normative, conceptual and methodological challenges to incorporating these broader outcomes. Measuring instruments have been developed to capture non-health domains, but valuing these outcomes poses challenges. Considering non-health outcomes increases complexity, but may provide a more comprehensive assessment.

1. Challenges associated in going beyond health-related
quality of life in cost-utility analysis
Lidia Engel, MSc
Saskatoon, April 14th, 2015
PhD Candidate
David GT Whitehurst, PhD
Stirling Bryan, PhD
Scott A Lear, PhD

2. Background Theoretical issues Normative issues Conceptual issues Methodological issues Practical issues
2
Background
Background
• Policy decisions are often being informed by
economic evaluations that measure outcomes using
quality-adjusted life years (QALYs)
• The utility values are
often estimated using
preference-based
measures of HRQoL,
such as EQ-5D, SF-6D, or
HUI
Source: Whitehead SJ & Ali S (2010).

3. Background Theoretical issues Normative issues Conceptual issues Methodological issues Practical issues
3
Health-related quality of life (HRQoL)
HRQoL focuses on
domains of QoL that
can be expected to be
affected by health
alone (health-related)
Background
Adapted from Brazier J. (2007).

4. Background Theoretical issues Normative issues Conceptual issues Methodological issues Practical issues
4
Health care services may result in outcomes other than health and may
impact broader aspects of QoL, for example:
- Independence
- Dignity
- Self-respect
- The ability to cope
- Etc.
These outcomes are not only affected by
health alone (non-health outcomes)
Individuals may derive value from the actual processes of providing
care (process utility)
Problem
Background
Ignoring these broader outcomes can lead to a
misallocation of scarce resources

5. Background Theoretical issues Normative issues Conceptual issues Methodological issues Practical issues
5
Instruments that go beyond HRQoL – ICECAP & ASCOT
Background
http://www.birmingham.ac.uk/research/activity/mds/
projects/HaPS/HE/ICECAP/ICECAP-A/index.aspx http://www.pssru.ac.uk/ascot/domains.php.

6. Background Theoretical issues Normative issues Conceptual issues Methodological issues Practical issues
6
Influence on the conclusion of an economic evaluation
“All results suggest that, using the ICECAP-O, the intervention has a higher
probability of cost-effectiveness than with the EQ-5D at the same level of WTP.”
Background
Makai P. et al. (2014).

7. Background Theoretical issues Normative issues Conceptual issues Methodological issues Practical issues
7
Types of economic evaluation and the evaluative space
Background
Cost-benefit analysis:
Costs: Monetary units ($)
Benefits: Monetary units ($)
Cost-utility analysis:
Costs: Monetary units ($)
Benefits: QALYs
All kinds of benefits
Outcomes beyond health ✔
HRQoL
Outcomes beyond health
Challenges?
?

8. Background Theoretical issues Normative issues Conceptual issues Methodological issues Practical issues
8
Theoretical issues
Theoretical issues
Welfarism
Narrow
Extra-welfarism
(Culyer 1991)
Broad
Extra-welfarism
(Brouwer et al. 2008)
Maximization
rule
→ Maximize social
welfare
→ Maximize health
(expressed in QALYs)
→ Maximization rule is
context-dependent
Non-health
outcomes?
→ Yes, if individuals
derive utility from it
→ Indirect (only if they
contribute to health)
→ Yes, if a decision-maker
with authority decides to
include them
• In theory, non-health outcomes can be included within the QALY framework
• One of the ‘extras’ in extra-welfarism allows to broaden the evaluative space

9. Background Theoretical issues Normative issues Conceptual issues Methodological issues Practical issues
9
Normative issues
Why should we go beyond health?
 Interventions provide benefits beyond health
 Can influence the conclusion of an economic evaluation
 To enable comparisons across a broader range of interventions
(e.g., drugs and public health services)
 To judge whether interventions offer ‘value for money’

10. Background Theoretical issues Normative issues Conceptual issues Methodological issues Practical issues
10
Normative issues
Societal preferences
What does the society value most in
health care priority setting?
The perspective from a
representative sample
in British Columbia
Source: Bansback N. et al. (2014).
…right term?

11. Background Theoretical issues Normative issues Conceptual issues Methodological issues Practical issues
11
Defining non-health outcomes
Conceptual issues
“Non-health outcomes were not strictly defined a priori, but included features
of the intervention (e.g. invasiveness), features of the healthcare process
(discomfort, duration, healthcare professional), or subjective/perceived impact
on patients (embarrassment, uncertainty, cosmetic).” Opmeer BC. et al. (2010).
Goebbels AFG. et al. (2012).
“Non-health outcomes were defined as all outcomes not captured by EQ5D-
based QALYs.”

12. Background Theoretical issues Normative issues Conceptual issues Methodological issues Practical issues
12
Conceptual issues
Health outcomes vs. non-health outcomes
Usual activities
Self care
Mobility
Anxiety/ depression
Pain/discomfort
Attachment
Enjoy
ment
Security
EQ-5D-5L
Health outcomes?
ICECAP-A/O
Non-health outcomes?
Role
Control
Stability
Achievement
Autonomy

13. Background Theoretical issues Normative issues Conceptual issues Methodological issues Practical issues
13
Conceptual issues
http://www.aqol.com.au/do
cuments/AQoL-
8D/AQoL8D_structure_supe
rdimensions.png

14. Background Theoretical issues Normative issues Conceptual issues Methodological issues Practical issues
14
Methodological issues
Measuring non-health outcomes
 Developing new measures
• ICECAP instruments
• ASCOT instruments
 Bolt-ons/add-ons/dimension extension
• NICEQoL Project
• EQ-5D-dignity (Dixon S. et al. (2013)
 Which additional dimensions?
• More generic? More specific?
• Are non-health outcomes relevant for all clinical areas?
Double counting might occur if instruments measuring non-health
outcomes are applied alongside preference-based HRQoL instruments

15. Background Theoretical issues Normative issues Conceptual issues Methodological issues Practical issues
15
Methodological issues
Valuation of non-health outcomes
1)
2)

16. Background Theoretical issues Normative issues Conceptual issues Methodological issues Practical issues
16
Methodological issues
1. Selection of the valuation technique
• Choices that involve trade-offs
• Risk of immediate death
• Should be practical, reliable and valid
• Discrete-choice experiment seems to be a promising technique
2. Full health-dead scale
3. Worse than dead health states
4. Duration: non-health outcomes are of temporary nature
5. Who should value?
Considerations for valuing non-health outcomes

17. Background Theoretical issues Normative issues Conceptual issues Methodological issues Practical issues
17
Practical issues
Practical issues
 Pragmatism
 Comparability
 Consistency
Going beyond health-related QoL will
increase the complexity of health-care
decision making!

18. Background Theoretical issues Normative issues Conceptual issues Methodological issues Practical issues
18
Perspectives in HTA
 Health care perspective
- Resources are insufficient to meet all demands 
Health is the appropriate maximand that should be used
in resources allocation decisions
- Example: NICE (UK), CADTH (CA)
 Societal perspective
- All costs and benefits are taken into account, regardless
of where these costs and benefits occur
- Example: CVZ (NL)
Practical issues

19. Background Theoretical issues Normative issues Conceptual issues Methodological issues Practical issues
19
HTA process and non-health outcomes
Practical issues
Assessment stage:
Clinical and cost-effectiveness
evidence is gathered
Appraisal stage:
Recommendations are made
Cost-utility analysis:
What is the outcome?
1. Quality-adjusted life years (QALYs)
2. Wellbeing-adjusted life years (WALYs)
3. Social-care QALYs
4. Capability QALYs
5. Process-adjusted QALYs
6. Super QALY (health and non-health)
7. ?
Comparability?
 NICE: ICER > £20,000 per QALY gained
• Degree of certainty around ICER
• Change in QoL inadequate captured
• Innovation
 “Social value judgments”

20.  Solve conceptual issues first
• Conceptual framework is needed
• How do we define non-health outcomes?
• What can be considered as process-related what is an outcome?
 Examine existing preference-based HRQoL measures
• To what extent do they already capture outcomes that go beyond health?
• Avoid double-counting
 Communicate the results with decision makers early on
Conclusion and next steps

21. Thank you for your attention!
lengel@sfu.ca
Acknowledgements:
Supervisory Committee:
 David GT Whitehurst, PhD
 Stirling Bryan, PhD
 Scott Lear, PhD

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