CPHAHPV 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

• 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/S0140-6736(13)62218-7

Prof Emeritus Public HealthUniversity 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 Colposcopy2010

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 coverageNL 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 professionalsInformed consentFact sheet to facilitate consentPost immunization fact sheetInformation 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

75

80

85

90

95

100

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 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)

Data Sources

Cancer Risk Management Model (CRMM) overview

Screening

Target populationsParticipation ratesVarious modalities

Cancer

IncidenceTreatment

Progression

Outcomes

Cancer incidence

Cancer deaths

Resource needs

Direct Health Care costs

Cost per life-year gained

Life expectancy

Health-adjusted LE

Economic impacts

Risk Factors

LifestyleEnvironmental

Socio-Economic StatusPresence of virus

New Treatment

Δ CostΔ Survival

Δ Health utility

Sex

Ag

eY

ear

Pro

vin

ce

http://goanimate.com/videos/0ObXRlXaYuMQ?utm_source=linkshare

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Epidemiological Evaluation of Screening Policies

* non-age-standardized data

Incidence of Cervical CancerEffect of screening interval

MortalityEffect of screening interval on cervical cancer deaths

* non-age-standardized data

* non-age-standardized data

IncidenceEffect of age at starting screening on new cervical cancer cases

No incremental benefit to screening 18-20 year-olds when compared to screening 21-69

MortalityEffect of age at starting screening on cervical cancer deaths

* non-age-standardized data

IncidenceEffect of screening participation on new cases of cervical cancer

Interval: triennialAge: 21-69

Interval: triennialAge: 21-69

50% reduction

HPVMM 1.6

68% reduction (from no vaccination) at year 2052

Additional 8% reduction (from no vaccination) at year 2052

42% difference

IncidenceImpact of screening & vaccination on new cases of cervical cancer

* non-age-standardized data

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• 40% reduction in incidence cases at year 2052

• 17% reduction in cumulative incidence cases (2012-2052)

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 EndThank you

Discussion & Questions