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Estimating survival gain for cost-effectiveness analysis: The example of early hormonal treatment in locally advanced prostate cancer

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The Open Society Foundation for Albania & The Open Society Fund-Lithuania Cervical Cancer Prevention in Eastern-Europe & C-Asia Durres, Albania, March 11-13, 2004 – PowerPoint PPT presentation

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Title: Estimating survival gain for cost-effectiveness analysis: The example of early hormonal treatment in locally advanced prostate cancer


1
The Open Society Institute, New York PATH,
Seattle, USA The Open Society Foundation for
Albania The Open Society Fund-LithuaniaCervica
l Cancer Prevention in Eastern-Europe C-Asia
Durres, Albania, March 11-13, 2004
Maximizing the Impact of Cervical Cancer
Prevention
M. ARBYN 1,2 1European Network for Cervical
Cancer Screening 2Scientific Institute of Public
Health, Brussels
2
Contents
  • Natural history of the disease, risk factors
  • Coverage and frequency of screening
  • Cost-effectiveness of screening using cytology
  • Cost-effectiveness of other screenng strategies
  • Brussels trial
  • Screening in the European Union

3
Natural history of cervical cancer
4
Natural history conceptual model (1)
5
(No Transcript)
6
Natural evolution severity of CIN(Östör, Int J
Gyn Pathol, 1993)
7
Rationale for screening policy definition
  • Effect reduction incidence invasive cancer
    cause-specific mortality
  • back ground risk
  • participation of the target population
  • chosen screen test sensitivity for progressive
    precursors lesions QA
  • compliance with efficicay of follow-up of
    screen-positives
  • Interval
  • sensitivity
  • sojourn time of precursors
  • Start age
  • age-specific incidence of cancer sojourn time
    of precursors

8
Costs of screening
  • Cost price of the screen-test (investment and
    recurrent costs) fees of health professionals
    logistical costs (transport, processing,
    storage) administrative costs (invitation,
    registration and analysis of data).
  • Specificity of the screen test cost of follow-up
    and treatment of women with false-positive
    results or having non-progressive screen-detected
    lesions (over-diagnosis).
  • Sensitivity of the screen test cost for
    follow-up and treatment of true positives to be
    off-set by cost savings in avoided treatment of
    advanced disease.
  • Human costs time spent by women to be screened,
    anxiety and discomfort for follow-up and/or
    treatment of women with true and false-positive
    results and consequences of delay in detection of
    cancer in false-negative women.
  • Specificity of quality control, triage and
    diagnostic follow-up procedures, contributing to
    increased positive predictive value and savings
    by avoiding treatment of false-positive women.
  • Quality of screen test, influencing the need for
    repeat tests.

9
Costs-effect estimation of European screening
strategies

10
Costs-effect diagram

V Ballegooijen, Eu J Cancer, 2000
11
Cost-effectiveness of HPV DNA detection in
addition to or as alternative for cytological
screening for cervical cancer(Brussels trial)
12
Background
  • Pap smear standard cervical cancer screening
    test Boyle, Ann Oncol, 2003
  • hr HPV DNA detection
  • recommended as a strategy allowing more optimal
    management of cases showing equivocal cytological
    findings JNCI, 2004
  • Several randomised trials are running opposing
    cytological screening versus HPV detection as
    primary screening test Franco, JNCI Monographs,
    2003.

13
Brussels trial, 2000 2003
  • HPV triage compared with primary HPV screening
    both in combination with liquid based cytology.
  • Funded by Europe Against Cancer, W. Geps Fund

13
BrusselsEORTC2003.ppt
14
Study Population
  • 3000 women
  • Gynaecology polyclinic VUB-Brussels in 2000/2003
  • Age
  • median 39.8 Y
  • range 15-94 Y
  • 82.8 between 25-64Y
  • Randomised in 2 groups A B

15
Experimental groups
  • Group A (n1500)
  • Pap smear
  • HPV test (all)
  • Group B (n1500)
  • Pap smear
  • HPV test (if ASCUS/LSIL)

16
Screening tests
  • Smear
  • Cervex-Brush? sample rinsed in a vial with
    preservation liquid
  • Processed with AUTOCYTE?
  • Interpreted Bethesda 1991
  • HPV-test
  • Hybrid Capture II? on residual fluid
  • Using probe for high risk HPV types

17
Follow-up
  • All HPV, HSIL or glandular abnormalities
    (AGUS) or worse, were called for further
    diagnostic exploration and treatment
  • Colposcopy/biopsy
  • Excision, conisation
  • Further follow-up
  • Outcome detection of histologically confirmed
    CIN2

18
Decision tree (DataPro, Treeage, MA, US)
Detection of CIN2 per 1 000 screened women
Cytological screening
7.7
Cytological screening HPV triage
12.4
HPV screening
14.7
Combined cytological HPV screening
16.4
19
(No Transcript)
20
Outcome of economical analysis
  • Costs per detected CIN2
  • Cost per screened women
  • Incremental cost per additional CIN2

21
Costs () for detection of CIN2
22
Cost-effectiveness of 4 strategies
Compared with baseline strategy
Incr.
Incr.
Cost-
Incr. cost-
Strategy
Cost
Cost
Effect
effect
effect
effect ratio
(detected
(detected
()
()
cin2)
cin2)
(/cin2)
(/cin2)
Cytological
screening
37.9
0.0077
4892
Cytological screening
HPV triage
43.4
5.5
0.0124
0.0047
3499
1170
HPV screening
104.1
66.2
0.0147
0.0070
7055
9457
Combined cytological
HPV screening
141.4
103.5
0.0164
0.0087
8617
11897
23
Influential variables
  • C/E most affected by
  • Cost of HPV testing
  • Prevalence of high-risk HPV types in screened
    population ( age)
  • Specificity of HPV tests

24
Conclusions
  • Cytology followed by HPV triage increases
    sensitivity for CIN2 substantially at a rather
    limited extra cost (ICERlt1200 /case)
  • Ancillary HPV testing still increases the yield
    of CIN2 but at a very high cost (ICER almost 12
    000/case)
  • Extra cost by adding HPV testing must be balanced
    by the possibility of increasing the
    screening-interval for HPV-negative women
  • ! Longitudinal dimension needed

25
Cancer Screening Policy in the EU(Council
recommendation)
26
Conference on Screening and Early Detection of
CancerNovember 18-19th, 1999, Vienna
  • Development of a European Strategy
  • Consensus reached Advisory Commitee on Cancer
    Prevention Eur J Cancer 2000 36 1473-8
  • Evidence organised screening can reduce
    cause-specific mortality from 3 cancers

27
EU Screening policies
  • Evidence organised screening can reduce
    cause-specific mortality from
  • Breast cancer
  • mammography, women 50-69 years, 2-year interval
  • Cervical cancer
  • Pap smear, women from ?20 ? 30 to ?60 years, 3-5
    year interval
  • Colo-rectal cancer
  • FOBT, men women 50-74 years, 1-2 year interval

28
Council recommendation on cancer screening(a
long way )
  • Delay in translation of consensus into regulating
    texts.
  • European consensus should be applied urgently by
    health ministers. Arbyn M, Lynge E, Micksche M,
    BMJ 2001 323 396.
  • Commissions Proposal for a Council
    Recommendation Brussels, 5th May 2003 (Ref
    2003/0093 (CNS).
  • Consultation of member states and EU Parliament
    (May-Nov 2003).
  • 2nd December 2003 endorsement of the Council
    ecommendation.
  • Meanwhile 3th Update European Code Against
    Cancer
  • Boyle P et al, Ann Oncol 2003 14 973-1005.

29
Summary of the Council recommendation
  • Based on the Vienna consensus
  • Argumentation updated
  • Screening policy less detailed
  • Mammography for women 50-69 years
  • Pap test for women starting at 20-30 years
  • Colo-rectal cancer screening for man women
    50-74 years
  • Screening only offered in organised programmes
  • Monitoring QA at all levels invitation,
    participation, screen test, follow-up of screen,
    treatment, after-care, registration, data-linkage
    (privacy!)

30
Summary of the Council recommendation (2)
  • Screening in accordance with evidence-based
    guidelines
  • Research on new screening methods (RCT, public
    health relevant outcomes mortality or
    established surrogate endpoints)
  • Assessment of level of evidence concerning
    effects of new methods by pooling results of
    trials
  • Note European guidelines
  • Cervix Network 2nd update in 2004
  • Note industrial lobbying!
  • Question screening in new MS of the EU?

31
Council recommendation but
  • European Cancer Networks (EBCSN, ECCSN, ECSN) not
    supported anymore in 2004
  • Only marginal attention for cancer in the 2004
    call for proposals
  • Nevertheless last article of the recommendation
  • to encourage co-operation between MS in research
    exchange of best practices evaluating new
    methods

32
References
  • Advisory Committee on Cancer Prevention.
    Recommendations on cancer screening in the
    European Union. Eur J Cancer 2000 36 1473-78.
  •  
  • Arbyn M, Van Oyen H, Lynge E, Mickshe M. European
    consensus on cancer screening should be applied
    urgently by health ministers. BMJ 2001 323 396.
  •  
  • Arbyn M, Van Oyen H, Lynge E, Micksche M, Faivre
    J, Jordan J. European Commission's proposal for
    a Council recommendation on cancer screening.
    BMJ 2003 327 289-290.
  •  
  • Boyle P, Autier P, Bartelink H et al. European
    Code Against Cancer and scientific justification
    third version (2003). Ann Oncol 2003 14
    973-1005.
  • Council of the European Union. Council
    Recommendation of 2 December 2003 on cancer
    screening (2003/878/EC). Official J Eur Union
    2003 L327 34-38.
  •  
  • Coleman D, Day N, Douglas G, Farmery E, Lynge E,
    Philip J, Segnan N. European Guidelines for
    Quality Assurance in Cervical Cancer Screening.
    Europe against cancer programme. Eur J Cancer
    1993 29A Suppl 4 1-S38.
  •  
  • Commission of the European Communities. Proposal
    for a Council Recommendation on Cancer Screening.
    2003/0093 (CNS). Brussels, 5th of May, 2003.
  •  
  • Perry N, Broeders M, de Wolf C, Törnberg S,
    Schouten J. European Guidelines for Quality
    Assurance in Mammographic Screening, 3rd edition.
    Office for Official Publications of the European
    Communities, Luxembourg, 2001.
  •  

33
Burden of Cervical Cancer
34
W-Age standardised mortality from and incidence
of cervical cancer European Union, 2000
Ferlay J, et al. GLOBOCAN 2000 Cancer incidence,
mortality and prevalence worldwide, Version 1.0.
IARC CancerBases No. 5. Lyon, IARC, 2001.
35
W-Age standardised mortality from and incidence
of cervical cancer Acceding EU member states
Finland, 2000
Ferlay J, et al. GLOBOCAN 2000 Cancer incidence,
mortality and prevalence worldwide, Version 1.0.
IARC CancerBases No. 5. Lyon, IARC, 2001.
36
Burden of cervical cancerEuropean Continent, 2000
  • Estimated number of cases 66,000
  • Number of deaths 29,000

Ferlay J, et al. GLOBOCAN 2000 Cancer incidence,
mortality and prevalence worldwide, Version 1.0.
IARC CancerBases No. 5. Lyon, IARC, 2001.
37
Cervical cancer mortality in Europe
Source Globocan 2000, IARC Map
produced by M. Arbyn
38
IARC\iarc.do
39
IARC\iarc.do
40
IARC\iarc.do
41
Number of deaths by cancer of the uterus
(Belgium 1954-94)
Arbyn M, Int J Cancer 2002
42
Estimated number of deaths by cancer of cervix
and corpus uteri (Belgium 1954-94)
Arbyn M, Int J Cancer 2002
43
Standarised mortality rate for cervical cancer
(Belgium 1954-94, European reference population)
24
22
Cervix uteri (certified)
20
18
16
14
deaths/100 000 women/y
Start screening
12
10
8
6
4
2
0
1955
1960
1965
1970
1975
1980
1985
1990
Year
Arbyn M, Int J Cancer 2002
44
Cervical cancer screening systems
45
Screening systems
  • Organised screening
  • more effective cost-effective
  • Finland, UK gt1990, Denmark, Sweden, Iceland, The
    Netherlands, Norway
  • Opportunistic screening
  • overscreening
  • heterogenous quality
  • in most other European countries

Miscan.xls
46
Effectiveness opportunistic versus organised
screening
  • Case-control study Finland (Nieminen, Int J
    Cancer, 1999)
  • History of previous Pap smears in 156 cancer
    cases, 1139 controls
  • OR for no screening (ref) 1
  • OR if organised screening 0.25 (.13-.48)
  • OR if opport. screening 0.57 (.30-1.06)
  • OR if org. opp. screening 0.27 (.15-.49)

Miscan.xls
47
National cervical cancer policies in EU countries
Miscan.xls
Van Ballegooijen M et al, Eur J Cancer 2000
48
Screening coverage in EU countries (Having had at
least 1Pap since screening interval)
European Network Cervical Cancer Screening, Eur J
Cancer, 2000 Rousseau A, Bull épid hebd, 2002.
49
Study current status CC screening in Europe
  • Update of the descriptive studies in 15 EU
    countries (Eur Network for CC screening Eu J
    Cancer, 2000)
  • Extension towards other countries of the European
    continent
  • In collaboration with

Miscan.xls
50
Questionnaire
  • In collaboration with
  • European Federation of Colposcopy
  • European Cervical Cancer Association
  • Developed by
  • M. Arbyn, J. Jordan, P. Nieminen, JJ. Baldauf

Miscan.xls
51
Questionnaire
  • Sent beginning January 2004
  • Answers received from Belgium, Croatia, Czech
    Republic, Denmark, Finland, France, Germany,
    Hungary, Iceland, Slovenia, Serbia, The
    Netherlands, Switzerland, UK
  • Contacts with Greece, Poland, Sweden, Norway,
    Latvia, Lithuania, Roumania, Estonia, Spain
  • March (Durres) Albania, Macedonia, Moldavia,
    Russian Fed, Moldavia, Georgia, Azerbedjan,
    Armenia
  • Q available m.arbyn_at_iph.fgov.be

Miscan.xls
52
Q1 National screening policy
  • Existing poliy
  • Yes UK, France, Hungary, Slovenia, Belgium,
    Netherlands, Germany, Denmark, Iceland
  • No Serbia, Czech R (pilot Pilsen Karvina,
    Croatia, Switzerland
  • (planned in all countries, at exception of
    Switzerland)

Miscan.xls
53
Q2-3 target age groups frequency (2004)
  • UK
  • 20-64 since Oct 2003? 25-64
  • In 25-49 every 3y in 50-64 every 5y
  • Belgium, Hungary 25-64/5 every 3y
  • France, Czech R 25-64, starting yearly, after
    2-tests every 3y
  • The Netherlands, Finland 30-60 every 5 y
  • Germany 20 every year
  • Slovenia 20-64, starting yearly, after 2-tests
    every 3y
  • Denmark 23-59, every 3 y
  • Iceland 20-69, every 2-3 y

Miscan.xls
54
Q5 Screening test
  • LBC UK gradual introduction over 5y
  • Pap smear /or colposcopy Serbia, Hungary
  • Pap smear other countries
  • HPV cytology in Croatia (?)

Miscan.xls
55
Q6 organised national programme
  • Yes UK, Finland, The Netherlands, Slovenia,
    Denmark, Iceland
  • Regional France (4), Belgium (1), Czech R (2)
  • Q9 who invited?
  • All (call) UK, The Netherlands, Finland
  • Not recently screened women (call-recall)
    Denmark, Hungary, Slovenia, Iceland, Czech R

Miscan.xls
56
Q17 Cytological report form
  • Yes
  • UK BSCC
  • The Netherlands KOPAC/Pap
  • Bethesda 2001 France, Belgium, Hungary,
    Slovenia, Czech R, Croatia (Zagreb 2002), Finland
  • No Germany, Serbia, Switzerland

Miscan.xls
57
Q19 informed consent for data registration
  • No, opportunity is given to refuse UK, France
  • No Denmark, Finland, Hungary, Iceland
  • Yes Belgium, Germany (mammography screening),
    Czech R (oral)
  • Other countries no answer or no registration

Miscan.xls
58
Q 21 screening coverage UKEngland, 2003, 5-year
coverage for Pap smear screening

Paris2003Coverage.xls
59
Q 21 screening coverage The Netherlands, 2001,
5-year coverage

Paris2003Coverage.xls
60
Q 21 screening coverage France 1995-2000, of
women with Pap lt 3y ago

Paris2003Coverage.xls
61
Screening status in Belgium(Health Interview
Survey, 1996 2000)
  • Women 25-64 years, Pap smear lt 3 years ago
  • Flemish Region 74.0 (70.6-77.4 )
  • Walloon Region 64.0 (60.9-67.1 )
  • Capital Region Brussels 64.1 (60.7-67.5 )
  • HIS 2000 2-3 higher

62
Belgium screened lt 3 years ago (Flemish
Region, 1996, telephone interview)
63
Other questions
  • Health education, promotion
  • Data registration linkage procedures
  • Result communicaton
  • Prevalence of cytological lesions
  • Guidelines for management
  • Publication, documents
  • For the details questionnaire suggestions
    m.arbyn_at_iph.fgov.be
  • Work will be continued throughout 2004
  • Feedback with country representatives
  • Summary spread sheet on web side of collaborating
    partners
  • Joint publication

64
To conclude
  • Large heterogeneity in cervical cancer screening
    systems in Europe
  • Aim of the current study to document this over
    all countries of the continent, share information
    will all concerned partners
  • Hope that European guidelines will invite health
    authorities decision makers, stakeholders,
    members of the European Federation of Colposcopy
    to more evidence cost-effective approaches to
    offer the best available quality to as much as
    women as possible

65
To conclude (2)
  • To hope
  • European Commission will accept to set up again
    Networks for Cancer screening
  • In order to realise the principles of the
    European Council Recommendation on Cancer
    Screening
  • A fortiori useful for the 10 acceding member
    states
  • Collaboration with other European/American/Asian
    initiatives
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