Prof. Dr. Jan J.V. Busschbach Measuring the “Q” in QALYs for cost-effectiveness: the EuroQol Group’s approach National EQ5D Symposium and Workshop 3 – 6 August, 2016 Penang, Malaysia. Prof. Dr. Jan J.V. Busschbach Erasmus MC, Rotterdam, The Netherlands Section Medical Psychology and Psychotherapy Department of Psychiatry Conflict of Interest Member of the EuroQol Group Chair of the EuroQol Research Foundation

Quality Adjusted Life Years: QALYs Example Blindness Quality of life value = 0.5 Life span = 80 years 0.5 x 80 = 40 QALYs Most debate 0.00 1.00 X 0.5 x 80 = 40 QALYs Life years 40 80 2 2

Uni-dimensional value QALYs need a uni-dimensional value Like the IQ-test measures intelligence QALYs need a ratio or interval scale Difference 0.00 and 0.80 must be 8 time higher than 0.10

Five methods…. have the pretention to measure interval… Visual analog scale Time trade-off Standard gamble Person Trade-off Discrete Choice

13.000 QALY publications

Visual Analogue Scale From psychological research Main critique Also called “category scaling” Rescale from 0.00 to 1.00 Main critique No guarantee ratio scale Lower value then face value

Time Trade-Off (TTO) Wheelchair With a life expectancy: 50 years How many years would you trade-off for a cure? Max. trade-off is 10 years QALY(wheel) = QALY(healthy) Y * V(wheel) = Y * V(healthy) 50 V(wheel) = 40 * 1 V(wheel) = .80 Main critique Discounting effect More complicated than VAS

Standard Gamble SG Wheelchair Life expectancy is not important here How much are risk on death are you prepared to take for a cure? Max. risk is 20% wheels = (100%-20%) life on feet V(Wheels) = 80% or .8

Problems Patients values tent to be too high We rather have values from the general public Time Trade-off is cumbersome

Patients values tend to be too high Stensman Scan J Rehab Med 1985;17:87-99. Scores on a visual analogue scale 36 subjects in a wheelchair 36 normal matched controls Mean score Wheelchair: 8.0 Health controls: 8.3 Healthy Death

Coping Medicine: Coping Is a good thing for patients… Quality of life: Response shift Psychology: Cognitive dissonance reduction Economics: Preference drift Is a good thing for patients… ….but it not handy in measurement

Should we have patient values? In a normal market: the consumer values count The patient seems to be the consumer Thus the values of the patients…. If indeed health care is a normal market… But is it….? 12

Health care is not a normal market…. Supply induced demands Government control Financial support (egalitarian structure) Patient  Consumer The patient does not pay Consumer = General public Potential patients are paying Health care is an insurance market A compulsory insurance market 13

Health care is an insurance market Values of benefit in health care have to be judged from a insurance perspective Who values should be used the insurance perspective? 14

Who determines the payments of unemployment insurance? Civil servant Knowledge: professional But suspected for strategical answers more money, less problems identify with unemployed persons The unemployed persons themselves Knowledge: specific General public (politicians) Knowledge: experience Payers 15

Who’s values (of quality of life) should count in the health insurance? Doctors Knowledge: professional But suspected for strategical answers See only selection of patient Identification with own patient Patients Knowledge: disease specific But coping General public Knowledge: experience Payers Like costs: the societal perspective 16

Time Trade-off is cumbersome Can we not find a more simple way?

TTO validated questionnaires MOBILITY I have no problems in walking about I have some problems in walking about I am confined to bed SELF-CARE I have no problems with self-care I have some problems washing or dressing myself I am unable to wash or dress myself USUAL ACTIVITIES (e.g. work, study, housework family or leisure activities) I have no problems with performing my usual activities I have some problems with performing my usual activities I am unable to perform my usual activities PAIN/DISCOMFORT I have no pain or discomfort I have moderate pain or discomfort I have extreme pain or discomfort ANXIETY/DEPRESSION I am not anxious or depressed I am moderately anxious or depressed I am extremely anxious or depressed X X X 22221 X X

Solvings problems Problems Solutions: Validated TTO questionnaires Patients values tent to be too high We rather have values from the general public Time Trade-off is cumbersome Solutions: Validated TTO questionnaires No patient values involved Given values from the general public Easy to administer

The Rosser & Kind Index 20

Criticism on the Matrix Sensitivity only 30 health states The unclear meaning of “distress” The involvement of medical personnel No clear way how to classify the patients into the matrix Only British values The compression of states in the high values 21

Value compression 22

New initiatives Higher sensitivity (more then 30 states) More and better defined dimensions Values of the general public A questionnaire… to allow patients to ‘self classify’ themselves An international standard to allow international comparisons That is at that time “Europe” Better valuation techniques Standard Gamble, Time Trade-Off, Visual Analogue Scale

EuroQoL Group First meeting 1987 Participants from UK, Finland, Sweden, The Netherlands A common core instrument To allow international comparisons To allow linking of international results Instrument should be small Suitable for sever ill patients The emerging of high tech medicine, especially transplantation

The first EuroQol Higher sensitivity (more then 30 states) More and better defined dimensions 6 dimensions Mobility; Daily activity and self care; Work performance Family and leisure performance Pain/discomfort Present mood Other valuation techniques Visual Analogue Scale

The first EuroQol Values of the general public A questionnaire Values from general public But also values from patients (!) A questionnaire to allow patients to ‘self classify’ themselves A international standard to allow international comparisons That is at that time “Europe”

Validated Questionnaires Most used at this moment SF-6D HUI Mark 2 & 3 EuroQol EQ-5D-3L & EQ-5D-5L AQoL Typical validation study Time Trade-off Involved a representative sample of the general population N = [300…5.000] Done per country

National value sets Because translations differs… Values must follow translations Because culture differ Values must follow culture National value sets EQ-5D EQ-5D-3L Belgium, Denmark, Europe, Finland, France, Germany, Japan, New Zealand, Netherlands, Singapore, Slovenia, Spain, UK, USA, Zimbabwe EQ-5D-5L England, Japan, Canada, Uruguay, Netherlands, China, Korea, Singapore, Indonesia

The EQ-5D-5L questionnaire Versi Bahasa Melayu untuk Malaysia

Valuation study Malaysia Prof Dr Asrul Akmal Shafie Universiti Sains Malaysia Prof Dr Nan Lou National University of Singapore The EuroQol Group

Typical EuroQol Study EQ-5D-5L 1000 respondents general population Representative for age, gender, Using advanced quality control Computer guided time trade-off interview Specific training of interviewers Online quality checks during research by the EuroQol office

First international comparisons in 1988 with EQ-6D and VAS

Does TTO differs?

Replication TTO in the UK

Positive TTO values differ little

Negative TTO values differ

Importance of quality control TTO vulnerable for interviewer effects Especially with negative values Quality control avoids ad hoc modeling UK from data to value set > 1 year Indonesian…. 3 days Credibility

Indirect utility assessment

Direct utility assessment 39

Patient values included

EQ-5D as the reference case

NICE requests a QALY analysis a strong preference for a single QoL instrument Recommend EQ-5D NICE methods guide 2008 But acknowledges that EQ-5D data not always available EQ-5D may not always be the appropriate measure.

Reference case In practice Deviations are allowed But…. In the UK, EQ-5D is the reference case Demanded by NICE in health economic evaluation Every drug assessed for reimbursement Deviations are allowed Must be motivated But…. If motivation fails…. So EQ-5D is include most of the times

Other countries Reference case in other countries as well Not as clear as in UK In Netherlands EQ-5D has been made compulsory Has propelled the EQ-5D Most used in questionnaire in health economics

Why EQ-5D as reference? UK strong tradition in health economics York University York involved in the EuroQol Group Massive grant to develop UK TTO value set NHS N = 3000

Pragmatic reasons The EQ-5D is short Is available in many languages Can be done beside other questionnaires Is available in many languages EQ-5D-3L: 171 languages EQ-5D-5L: 138 Cheap Non commercial use is free Most large companies have a subscription

EQ-5D was develop as a reference case 1988 In need of compatibility of research To make European research efforts comparable ‘a basic common core of QoL Characteristics’ The European Common Core Group Note: no ‘gold standard’ ‘for use alongside more detailed condition specific […] measures’

EuroQol is noncommercial Is not owned by some one…. No stocks EuroQol Research Foundation Money is put back in research Malaysian validation study In part financed by EuroQol

Part of the academic society Can effort the questionnaire Often used Are allowed to further develop EQ-5D In the Netherlands explicitly asked to help valuated All important university complied High acceptance in Academia

Most studied questionnaire EQ-5D is not necessary the best But we know in detail: The good things The bad things

Evidence on EQ-5D: some examples Hearing Prostate Erectile dysfunction Schizophrenia Bipolar disorder Vision Breast reconstruction Depression and anxiety Some cancers Skin Personality disorder

Conclusion Malaysia… EQ-5D-5L will have a valued EQ-5D-5L in 2018 …is a good candidate to be a reference case