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CPHA
HPV Vaccination into Cervical
Cancer Screening: NL lessons
learned
Cathy O’Keefe, Cathy
Popadiuk, Joanne Rose
May 27, 2014
Disclosure
• Cathy Popadiuk
• Speaker and Advisory Board Contributions
to Merck and GSK for HPV vaccination
and cervical screening.
• Cervical Cancer Lead for the HPV- Cervix
Cancer Risk Management Model (CPAC)
Objectives
• Describe the elements for implementation of
an organized prevention and screening
programme applicable to all systems.
• Identify barriers to achieving a successful and
seamless prevention and screening
programme.
• List strategies to facilitate creation of
common goals to achieve streamlining of
seemingly fragmented processes and goals.
Newfoundland and
Labrador
Organized Cervical Cancer Screening
Dr Cathy Popadiuk MD, FRCS
History of Pap Smear
Screening in Canada
• 1949: BC - Boyes and Fidler started
centralized system
• 1950: Ontario started. Lab organized
1957
• 1962: 6.3% Canadians screened
• 1967: 26% Canadians screened BUT only
13% of women in Newfoundland
screened!
National History
• 1976: Walton National Task Force concluded need
organized screening program
• 1982: Task Force reconvened. Same recommendations
• 1989: National Workshop on Screening for Cancer of
the Cervix. 27 recommendations
• 1995: Interchange 95 National Workshop to assess if
recommendations still valid
• 2004 Pan Canadian Forum on Cervical Cancer
Screening
• 2006 Federal Government Funding for HPV Vaccination
• 2013 Canadian Task Force Preventive Health Guidelines
Components of Organized
Screening Program
•
•
•
•
Information Systems
Quality Control and Improvement
RECRUITMENT
Education of service providers and attendees
Failure Analysis
•
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•
•
•
•
•
•
Failure to attend screening
Failure to take a satisfactory smear
Failure to fix and stain the smear
Failure to identify abnormal area on smear
Failure to classify abnormality on smear
Failure to recommend investigation and Rx
Failure to attend for investigation and Rx
Inadequate treatment or follow-up
NL: Cutting Edge Cervical Cancer
Prevention and Screening
Coordination and evaluation of new
technologies and products challenging
to all health care providers
Where are the Canadian
Provinces and Territories Today
with Cervical Cancer Prevention?
Provincial Screening
Programmes
HPV Immunization Programmes
in Canada
What is happening in the rest of
the World with Cervical Cancer
Screening and Prevention?
www.thelancet.com Published online
November 3, 2013
http://dx.doi.org/10.1016/S01406736(13)62218-7
Prof Emeritus Public Health
University of Toronto
• “This is the second study to report no long term benefit
of HPV screening over cytology (the earlier paper was
on a trial in Finland). Their conclusion is that the
earlier trials showing sensitivity benefit of HPV
screening over cytology was an early diagnosis
phenomenon, not over diagnosis from HPV testing.
• But this also means that the delay associated with the
lesser sensitivity of cytology had no long term
disadvantage.
• So that as in some respects there is the likelihood of
an adverse quality of life for longer duration living with
the knowledge of an abnormal screening test,
choosing between the two for policy purposes will
depend on relative costs, not effectiveness.”
Lancet 2011; 377: 2085–92.
Discussion & Questions
Program structure of the
Newfoundland and Labrador
Cervical Screening Initiatives Program
Joanne Rose
Program Elements:
√ Target group & frequency for screening
√ Informed target group
√ Means to invite women for screening and
re-screening
√ Competent facilities for collection, processing &
reporting pap tests
√ Means to ensure women with abnormal test
result attend for care
Program Elements:
continued..
√ Effective and efficient treatment of abnormalities
√ Means of monitoring coverage of women at risk
and other relevant process measures
√ Means of monitoring disease in population and
relating to screening history
X Population database
HCP involvement
Screening Modality
• Screening target women ages 20-69 years
• Liquid Based Cytology (LBC)
• Reflex testing for HPV
for women over 30
√
years of age with a diagnosis of a
borderline abnormality (ASCUS)
• Available through some 700+ health care
providers (HCPs) throughout the province
Participation of target
Contact with Women
Limitation: Privacy barrier
Invitation system via the HCP’s
generated annually to all recruited HCP
Follow up for abnormal cytology via HCP x
2, then correspondence directly to women
Competent facilities:
• Laboratory quality assurance (OLA &
Bethesda)
• Programmatic indicators for turn around
time, diagnostic statements, time to
colposcopy, biopsy taken and cytology
histology correlation
Abnormal Follow up:
Effective Treatment
Limitation: geography, 4 RHAs, no
established communication linkage…
•Provincial Colposcopy Committee Structure
•Comprehensive Environmental Scan with
patient flow, service provision, wait times
and best practice review.
Wait time to Colposcopy
2010
Monitoring:
Women ages 20 to 69 years:
• Participation rates 2009-2011: 74%
• Retention Rates 2009-2011: 81%
• Age standardized Incidence Rate: 16%
• Disease diagnosed at stage 1: 58%
Population Database
Limitation: Privacy legislation
Allow for linkage for individual women
requiring follow up of abnormal cytology.
Currently a provincial registry committee
addressing the most expedient way to work
with the legislation.
Provincial Cervical Cytology Registry
PCCR
Joanne Rose (on behalf of Susan Ryan for
the NL Cervical Cytology Registry)
Registry:
Provincial Cervical Cytology Registry (PCCR)
• Centralized database of all pap reports,
HPV test results, and high grade positive
biopsy results, plus related colposcopy
reports
Limitations:
Colposcopy reports are submitted on paper
Biopsy records are only for high grade dx
Solution?
• Electronic Health Record for colposcopy
with a built interface for transfer to PCCR
• Pathology extract for all gynecological
surgical reports including biopsies,
endocervical curretage and
hysterectomies.
How to make this work?
Next steps for PCCR
• Integration of HPV vaccine data
Limitation: no population database,
solution to incorporate new patient
information first and then new vaccine
records thereby creating our new population
cohort
Limitation: no field for record, solution
build a new field in PCCR with patient
identifiers
What will this do?
• Allow monitoring of the indicators such as
participation and retention
• Allow monitoring of disease in vaccinated
and un-vaccinated population
• Allow for research opportunities and
surveillance of HPV genotyping
Discussion & Questions
HPV VACCINATION AND THE
INTEGRATION INTO THE CERVICAL
SCREENING PARADIGM:
NACI
recommendations
• NACI initial statement February 2007
Prevent cervical cancers caused by HPV infection
• NACI statement updated in 2012
HPV4 (Gardasil®) is recommended in males between 9 and 26 years of
age for the prevention of anal intraepithelial neoplasia (AIN) grades
1, 2, and 3, anal cancer, and anogenital warts (NACI
Recommendation Grade A). NACI has determined that there is good
(Grade A) evidence to recommend the use of Gardasil® in males
between 9 to 26 years of age.
To date PEI and Alberta have announced programs for males
Getting started
21 March 2007
• Canadian Cancer Society Applauds Funding
for HPV Vaccine Announced in Federal
Budget
• TORONTO - The Canadian Cancer Society
applauds the federal budget announcement of
$300 million to help implement the HPV vaccine
across Canada. The vaccine will help protect
young women and girls from cervical cancer.
Getting the
best coverage
NL factors for choosing a cohort
• Age of initiation of sexual activity
• Impact of school size and class
attendance
• Duration of protection
• Ongoing surveillance and connection with
cancer registry
Regional Participation
• The key component of making this work is
collaboration with Regional Health
Authorities in planning
• Some of the questions- What works best:
– Grade
- Age
– Timing
- Involving teachers
– Materials for parents and teachers
– PH Nurse training
– Should we involve media
NL The process 2007
• Fall 2006 Communicable Disease Nurses and
Regional Medical Officers of Health were
provided scientific information on HPV infection
and vaccine
• Once NACI announced
– managers had heard that implementation was most
likely going to be fall 2008, but nevertheless did pass
this info on to lower level managers who had been
asked to work out the logistics...
– so when the announcement was made, there was
little difficulty mobilizing because much of the work
was done
HPV NL Implementation
August September 2007
• Policy developed
Materials:
Education for health professionals
Informed consent
Fact sheet to facilitate consent
Post immunization fact sheet
Information package for teachers
• Flexibility in regions for operationalization
Consent
Implementation
• PH Nurses in-service on science and
responding to parental concerns
• Materials printed
• Policies revised and distributed
• Work with Department of Education to
develop an information package for school
boards and teachers on HPV program
• Regions provided with vaccine, materials
for education
Adding another Cohort
• As many of the PT came on board and
costs reduced the key was to ensure
equitable use of all the NIS trust funding
• Add cohort grade 9 for 2 years
– Already completing a consent for Tdap
– Not covered in 08-09 by the grade 6 program
– 2 years
Result: 90% of females born 1994 and after
have been immunized
2007-2010
100
95
90
85
80
75
2007
2008
2009
2010
Goal
Reaching the goal
Why this works
• All post natal referrals in this region are sent to PH
nurses for follow-up.
• PH nurses use this opportunity to provide an
appointment for child health clinics. The first vaccinations
are at 8 weeks, two weeks later than the doctor’s the 6
week appointment.
• Also since the parent is called and an appointment is
provided for immunization, the parent is made to feel it is
important to have vaccines.
• All school based immunization programs are completed
by PH nurses allowing physicians to work toward their
scope of practice.
Why this works
• Single service provision of Childhood
immunization Program
•
•
•
•
Only one group responsible for provision of this service
Public Health Nurses cover all communities
Clear lines of communication for issues that arise
They are directed and follow provincial policies and
procedures.
• Have our immunization manuals to follow so there are
clear consistent messages
• Strong support from provincial office: prompt response to
concerns that arise
Why this works
• Issues and concerns were dealt with promptly. PHNs fell
their work is valued and they take ownership of the
immunization program.
• Vaccine products are changing continuously
• PHNs are immediately educated about any program
changes or changes to vaccine product
• Written materials such as tear off sheets are provided
promptly as well as product information
• Semi-monthly Public Health memo send from the CDCN
keeps the PH nurses abreast of changes
Opportunities
• Linking immunization records to the
cancer registry
• HPV monitoring and Surveillance
Committee
• Reviewing policy related to immunizing
males
Discussion & Questions
Tools to Help Put the
Information Together
At the Policy and Education Level
Evaluating Screening and (HPV)
Vaccination Strategies in Canada using
the Cancer Risk Management HPV
Microsimulation Model (CRM-HPVMM)
Data Sources
Data Type
Source
Mortality, Birth, Population projections
Vital Statistics (1950-2005), Census (2006, 2011)
Incidence, Staging
Canadian Cancer Registry (2004-2007)
Smoking rates, Population health
utilities
Canadian Community Health Survey (2000-2007),
National Population Health Survey (1994-2004)
Time use data
General Social Survey (2005)
Earnings, Transfers, and Taxes
Census 2006, SPSD/M v16.1 (2005)
Total health care expenditures
Canadian Institute for Health Information (2006)
Health care costs: diagnosis, treatment,
follow-up, palliative and terminal care
Ontario Case Costing Initiative (2007-2008),
Provincial formulary (2009), Provincial Ministries of
Health (2009)
Current treatment practice
Expert Opinion
Screening parameters, Lung cancer risk
equation, Radon mitigation options,
Radon exposure, sexual network, HPV
virus transmission
Literature
Cancer Survival
Chart review (1991-92), Literature (1981, 1990-2000,
2005)
Cancer Risk Management Model
(CRMM) overview
Target populations
Participation rates
Various modalities
New Treatment
Δ Cost
Δ Survival
Δ Health utility
Incidence
Treatment
Progression
Year
Cancer
Sex
Screening
Cancer incidence
Cancer deaths
Resource needs
Direct Health Care
costs
Cost per life-year
gained
Life expectancy
Health-adjusted LE
Economic impacts
Province
Outcomes
Lifestyle
Environmental
Socio-Economic Status
Presence of virus
Age
Risk Factors
http://goanimate.com/videos/0ObXRlXaYuMQ?utm_source=linkshare
70
Epidemiological Evaluation
of Screening Policies
Incidence of Cervical Cancer
Effect of screening interval
2,500
2,000
1,500
1,000
500
Screening every 2 years
Screening every 3 years
Screening every 2.5 years
Screening every 5 years
0
2012
* non-age-standardized data
2017
2022
2027
2032
2037
2042
2047
2052
Mortality
Effect of screening interval on
cervical cancer deaths
1,000
900
800
700
600
500
400
300
200
100
Screening every 2 years
Screening every 3 years
0
2012
* non-age-standardized data
2017
2022
2027
Screening every 2.5 years
Screening every 5 years
2032
2037
2042
2047
2052
Incidence
Effect of age at starting screening
on new cervical cancer cases
2,500
2,000
1,500
1,000
500
Age 18-69
Age 21-69
Age 25-69
Age 30-69
0
2012
* non-age-standardized data
2017
2022
2027
2032
2037
2042
2047
2052
Mortality
Effect of age at starting screening on
cervical cancer deaths
900
800
700
600
No incremental benefit to
screening 18-20 year-olds
when compared to screening
21-69
500
400
300
200
100
Age 18-69
Age 21-69
Age 25-69
Age 30-69
0
2012
2017
* non-age-standardized data
2022
2027
2032
2037
2042
2047
2052
Incidence
Effect of screening participation on new
cases of cervical cancer
4,500
Interval: triennial
Age: 21-69
4,000
3,500
50%
reduction
3,000
2,500
2,000
1,500
1,000
500
No screening
0
2012
2017
2022
70% screening
2027
50% screening
2032
2037
100% screening
2042
2047
2052
68%
reduction
(from no
vaccination)
at year 2052
Additional 8% reduction (from
no vaccination) at year 2052
HPVMM 1.6
Incidence
Impact of screening & vaccination on
new cases of cervical cancer
2,500
42% difference
2,000
1,500
1,000
500
70% screening, 0% vaccination
70% screening, 75% vaccination
0
2012
* non-age-standardized data
2017
2022
2027
2032
2037
2042
2047
2052
New cases of cervical cancer
• 40%
reduction in
incidence
cases at year
2052
• 17%
reduction in
cumulative
incidence
cases (20122052)
Model Summary
• Less frequent screening is more cost-effective
• Including vaccination programs with screening is
more cost-effective than screening alone
• There may be a threshold vaccination rate that
achieves an adequate reduction in cervical
cancer incidence (herd immunity)
Final Objective
• The objective for the panel is to offer
tangible solutions and action plans for
participants to bring back to their
respective regions..
In Summary
PREPAREDNESS MEETS
OPPORTUNITY
= LUCK
•Regardless of one’s particular political climate or
circumstances, perseverance and hard work will
eventually come together.
•Take on realistic short term goals in response to
abrupt perturbation
•Don’t lose focus for the end result!!!!
The End
Thank you
Discussion & Questions