QALYs and Ethics

Is there an ethical / valid alternative?

Prof. dr. Jan van Busschbach

11

Arguments reimbursement

Pro Effectiveness Compassion Solidarity Empathy

Contra Costs Cost effectiveness

2

Health Economics

Comparing different allocations Should we spend our money on

• Wheel chairs• Screening for cancer

Comparing costs Comparing outcome

Outcomes must be comparable Make a generic outcome measure

3

Outcomes in health economics

Specific outcomes are incompatible Allow only for comparisons within the specific field

• Clinical successes: successful operation, total cure• Clinical failures: “events”

“Hart failure” versus “second psychosis”

Generic outcome are compatible Allow for comparisons between fields

• Life years• Quality of life

Most generic outcome Quality adjusted life year (QALY)

4

Example Blindness Time trade-off value is 0.5 Life span = 80 years 0.5 x 80 = 40 QALYs

Quality Adjusted Life Years (QALY)

5

0.00

1.00

X

Life years40 80

0.5 x 80 = 40 QALYs

Area under the curve

0 10 20 30 40 50 60 70 800

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1

Co-morbidity

Psychotherapy

No psychotherapy

Life years

QA

LY

we

igh

ts

Cost per QALY

7

20 QALY gained €100.000 Cost per QALY

€100.000/20 QALYs = €5000/QALY

I want to live in…

Country A Life expectancy 80 Quality of life 0.8 Focus on common

diseases

Country B Life expectancy 78.8 Quality of life 0.75 Focus on rare

catastrophic diseases

8

QALY league table

Intervention $ / QALYGM-CSF in elderly with leukemia 235,958

EPO in dialysis patients 139,623

Lung transplantation 100,957

End stage renal disease management 53,513

Heart transplantation 46,775

Didronel in osteoporosis 32,047

PTA with Stent 17,889

Breast cancer screening 5,147

Viagra 5,097

Treatment of congenital anorectal malformations 2,778

9

The QALY straw man

10

How can quality of life be ‘objective’? How can you validly measure it?

In the past, much criticism

Cohen CB. Quality of life and the analogy with the Nazis. Journal of Medicine and Philosophy 8: 113-35, 1983.

Criticism remains

….the strictly fascist essence of those QALYs (so-called Quality-

Adjusted Life Years)…

13

10.915 QALY publications

0200400600800

100012001400

1970 1980 1990 2000 2010 2020

Pu

bli

cati

ons

1980[pdat] AND (QALY or QALYs)

14

Three problems with the criticism …..

1. Arguments represent aversion toward a limited budget2. Proposed alternatives turn out to be the same3. Even equity concerns are in need of QALY

1. Arguments often represent aversion limited budget

15

“…Wij hebben duidelijk aangegeven dat een discussie over "wat maatschappelijk nog aanvaardbaar is" [kosten per QALY] alleen gevoerd mag worden als geldverslindende "frivoliteiten" door de maatschappij […] zijn uitgebannen. Bijvoorbeeld "joint strike fighters“…

Kees van Bezooijen in his roll as Patient representative, 2007

16

Three problems with the criticism …..

1. Arguments represent aversion toward a limited budget2. Proposed alternatives turn out to be the same3. Even equity concerns are in need of QALY

2. Proposed alternative turns out to be the same…

17

TWiST Time Without Symptoms of disease and

subjective Toxic effects of treatment

HYE Health Years Equivalent

SAVE Saved Young Life Equivalent

DALY Disability Adjusted Life Years

Capabilities Amartya Sen

1818

Burden of Disease Project

WHO Global Burden of Disease (GBD) Impact of diseases world wide Estimates of epidemiology per disease

Mortality Quality of life losses

In need of one measure of health But WHO disliked QALY…

1919

Chris Murray

Harvard School of Public Health

Worked outside Health economics Med Decision Making

DALY Disability Adjusted Life Years Lost life years Lost Quality of life

2020

DALY / QALY

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1

0 10 20 30 40 50 60 70 80 90

Life years

Ad

jusm

ent

fact

or

DALY

QALY

QALYs are measured in an invalid way Life years is not the problem, thus… It must be the validity of quality of life assessment…

One should not use cost effectiveness Often referred to as ‘ethics’

Two points of critique

21

1.0

0.0A B C

Kw

alit

eit

van

lev

enFalsification QALY

22

Efficiency

EquityLif

e ye

ars

A B C

Falsification of life years

23

80

0

Lif

e ye

ars 60

40

20

24

Efficiency/equity debate

Cost per QALY represents efficiency But is our health care system based on

efficiency? In health care, next to efficiency…

Compassion Solidarity Empathy

Is (should) burden (be) a criterion?

25

0

5

10

15

20

25

30

Accepted Rejected

High burden Low burden

Pronk & Bonsel, Eur J Health Econom 2004, 5: 274-277

26

80

0A B C

Lev

ensj

aen

Costs/QALY as indicator of solidarity

26

60

40

20

€ 50.000

€ 30.000

€ 40.000

Costs/QALY versus Burden of disease

27

€ 80.000

€ 60.000

€ 40.000

€ 20.000

€ 0

Burden of disease

X

XX

XX

28

Three problems with the criticism …..

1. Arguments represent aversion toward a limited budget2. Proposed alternatives turn out to be the same3. Even equity concerns are in need of QALY

29

Dutch Council for Public Health and Health Care (De Raad voor de Volksgezondheid en Zorg, 2006)

QALYs moderate NICE’s decisions

At average levels for all covariates, a decision would have a 50% chance of rejection if its ICER were £45,118/QALY

Dakin, Devlin, Rice, Parkin, O’Neill, Feng (2014) The influence of cost effectiveness and other factors on NICE decisions. Health Economics, 2014

31

Conclusion

Quality of life can be measured Usual multidimensional Unidimensional: QALYs

QALYs can validly be use in cost effectiveness research

Burden of disease is also a criterion On need QALYs to measure burden