Renewal of the National Cervical Screening Program

Consultations - Dr Tracey Bessell on behalf of Prof ian Hammond

Page last updated: 31 August 2016 (this page is generated automatically and reflects updates to other content within the website)

Since 1991 in Australia:

  • biennial pap tests , 18-69yo
  • 50% incidence and mortality
  • constant for past decade

Cervical Cancers

  • squamous cell (~80%) 65
  • adenocarcinomas (~20%) 25
  • other (~<2%) 5 –

    no suitable screening test


Currently 80% of Australian women with cervical cancer are lapsed or never screeners.
2 Diagrams. First diagram: showing the fallopian tube, ovaries, womb, cervix and vagina. Second diagram: showing the transformatino zone showing position of abnormal cells.Description of image

What (the Renewal)

  • To ensure the success of the program continues and all Australian women, human papillomavirus (HPV) vaccinated and unvaccinated, have access to a cervical screening program that is based on current evidence and best practice.

Why

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  • New scientific knowledge on the development of cervical cancer.
  • New international and local evidence for cervical cancer prevention and screening
  • New technologies
    • liquid-based technology
    • computer assisted image analysis
    • HPV tests
  • 2007 - National HPV Vaccination Program (girls)
  • 2013 - National HPV Vaccination Program (girls + boys)
  • Current NCSP is intensive compared to other countries

How

  1. Assess the evidence of screening pathways – including tests, interval + age range, for HPV vaccinated and unvaccinated women.
  2. Determine a cost-effective screening pathway and program model.
  3. Improve national data collection systems and registry functions.
  4. Assess the feasibility and acceptability of the renewed program.

When


Nov 2011 – RSC inaugural meeting
Mar 2012 – Partner Reference Group meetings
May 2012 - Public Consultation - Renewal DAP
Jun 2013 – Public Consultation - draft Review of Evidence
Oct 2013 – ESC of MSAC meeting
Nov 2013 – MSAC meeting
Dec 2013 – SCoS meeting
Apr 2014 – MSAC meeting
Jun 2014 – Policy and Implementation Plan
Sep 2014 – AHMAC meeting
2016 ??? – Implementation + changes

Stakeholder involvement

  • Open, informal Partner Reference Group
  • Regular email newsletters
  • March 2012 – workshops
  • May 2012 – DAP consultation
  • June – July 2013 – Draft Review of Evidence
  • Early 2014 – consultations / workshops
  • Registry functions
  • Colleges
  • Service Providers
  • Consumer Organisations

Governance

RSC
multidisciplinary, plus
s + t reps (SCoS + PM)Top of page
Diagram showing governanceText version of diagram

MSAC Process


Text version of diagram

Primary Question

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Comparator

(Current program)

Scenario 1Scenario 2Scenario 3
Primary screening testConventional cytologyConvention cytologyLBCHPV DNA testing
Age rangeWomen aged 18-69 yearsWomen aged 25-64 yearsWomen aged 25-64 yearsWomen aged 25-64 years
Interval2 yearly3 yearly (aged 25-49) and

5 yearly (aged 50-65)

3 yearly (aged 25-49) and

5 yearly (aged 50-65)

5 yearly

Secondary Questions

Triage optionsComparator

(Current program)

Scenario 1Scenario 2Scenario 3
Additional technologyN/AN/AWith and without automated image analysisWith and without automated image analysis
Exit strategyMust have two normal cyctology tests within the last 5 yearsHPV DNA test at age 64 yearsHPV DNA test at age 64 yearsHPV DNA test at age 64 years
Self collectionN/AN/AN/AYes
Call-recall systemN/AYesYesYes

MSAC Considerations

  • Any potential changes to the Program must achieve equal or better outcomes for women.
  • Natural history of cervical cancer
  • Evidence – NHMRC Clinical Trials Group, Syd Uni
  • Economic – Lowy Cancer Research Centre, Uni NSW
  • New research papers (Oct 13 to Feb 2014)
  • Additional requested information
  • See - MSAC Public Document (MSAC website)

Natural history of cervical cancer

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Flow chart showing the natural history of cervical cancerDescription of diagram
  • HPV is a common cause of infections – many types and most women will get it at some time in their life. It can also be latent (return later).
  • HPV is transmitted through sexual activity, are transient and usually clear up by themselves with 1- 2 yrs
  • Persistent HPV infections can cause abnormal cell changes that may lead to cervical cancer.
  • High grade / CIN3 lesions – more than 1/3 of these will progress to invasive cervical cancer within 10–20 years

Adapted from J Clin Invest. 2011;121(12):4593-4599.
doi:10.1172/JCI57149



Additional papers

  • Ronco et al – Lancet, Nov 2013
    • Pooled data of 4 large European RCT
    • HPV screening = 60-70% greater protection against invasive cervical carcinomas compared with cytology
    • Supports HPV-based screening from 30 yo and at least 5yr intervals
  • Castanon et al 2014 - PLoS Med 11: e1001585.
    • Cervical screening at age 50–64 and the risk of cervical cancer over age 65
    • Supports rethinking 65 yo exit to include older women
  • Elfstrom BMJ 2014
    • increased sensitivity of HPV screening reflects earlier detection rather than overdiagnosis.
    • support screening intervals of five years for such women.
  • Arbyn Lancet Oncology 2014
    • HPV sampling by a clinician should be mainstream.
    • HPV self-collection - additional strategy to reach women not participating in regular screening program."
    • self sampling - choice of test matters more than collection device ie Dacron swab not self-sampling devices.

Additional information

  1. the comparative merits of the available HPV test technologies for primary screening and partial genotyping;
  2. the exit strategy at age 69 years, including HPV infection rates in older women;
  3. change management, costs and communications;
  4. presentation of disaggtregated MBS costs;
  5. further information regarding the potential links of cervical screening registers to the national HPV immunisation register; and
  6. further information on self-collection for HPV testing in under screeners and non-screeners, including likely uptake.

Evidence based recommendations

  • A new cervical screening test should replace the Pap test.
  • HPV tests detect the virus that is the first step in the development of cervical cancer.
  • HPV tests every 5 years for HPV vaccinated and unvaccinated women 25 to 74 yo because:
  • 5 yearly HPV test more effective than 2 yearly pap tests
  • benefits outweigh harms
  • Women with symptoms can have a cervical test at any age.
  • Invitations, recall, follow-up
  • Self collect HPV sample – under and never screeners

Advice

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  • five yearly cervical screening using a primary HPV test with partial genotyping and reflex LBC triage, for HPV vaccinated and unvaccinated women 25 to 69 yo, with exit testing for women up to 74yo.
  • self-collection of a HPV sample, … facilitated by a medical or nurse practitioner (or on behalf of a medical practitioner) who also offers mainstream cervical screening, for an under screened or never screened woman.
  • Delisting of current MBS items – 6 to 12 month transition.

What does this mean?

  • The procedure for collecting a cervical screening sample involves taking a small sample of cells from the cervix, placing it in a vial and sending it to the lab for testing.
  • If HPV is found, cytology testing (like the current Pap test) is automatically undertaken on the same sample to check if any abnormal cells are present, with no additional visit required.
  • There are 100s HPV, inc 13+ high risk oncogenic HPV types
  • Pooled genotyping = HR HPV+ or HR HPV-
  • Partial genotyping = HPV 16/18+ (most at risk), other HR HPV+ or HR HPV-
  • Triaging HPV+ test results, with reflex LBC, leads to appropriate colposcopy referral.
  • HPV and cytology co-testing does not demonstrate a clear advantage over HPV testing alone.
Flow chart describing the proposed cervical screening pathway.Description of diagram

HPV tests

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  • Current and future tests must:
    • comply with TGA regulatory framework for IVD medical devices
    • meet Meijer et al - guidelines for HPV test requirements for primary cervical screening and validation guidelines for candidate HPV assays
    • provide a pooled result for all high risk HPV genotypes and partial HPV genotyping for HPV16 and HPV18 +/-45; and
    • not be an in-house test.

LBC solution for HPV testing

  • The LBC solution needs to be validated for use with the HPV test that is being used and for subsequent LBC examination of HPV test-positive specimens.
  • Important to ensure that reflex LBC triage testing can occur using the same specimen and thus avoid the need to obtain another specimen.
  • There are different types of LBC solution available including ThinPrep PreservCyt Solution, SurePath medium, Specimen Transport Medium (STM) and brand specific solutions for HPV testing.

Estimated Volume changes/year

  • Pap tests ~ 2.4M to 0.
  • HPV tests ~ 55K to 1.3M+
  • LBC tests ~ ? to 340K
  • Colposcopies ~ 82K to 102K

HPV self-collection

  • international studies show that HPV self-sampling increases screening participation rate for never and under-screeners.
  • In Australia – self collection for STIs eg chlamydia
  • HPV self-collection not as effective as health professional collected sample but more effective than the current Pap test;
  • the accuracy of HPV self-collection varies for different types of sampling devices and HPV tests;
  • less cost effective than mainstream pathway.
  • If HPV+ test then must have an LBC sample collected for cytology testing.
  • self collection Pap/LBC – insufficient evidence
  • alternate choice only available to under or never screeners.

Young women

  • HPV prevalent in young women and regresses
  • Cervical cancer is very rare < 25 yo
  • Screening has not decreased mortality < 25 yo
  • HPV vaccination has reduced the risk of high grade abnormalities in young women.
  • Starting at 25yo reduces over treatment and minimises harms such as future pregnancy loss.

Older women

  • Benefits of screening outweigh harms for 25 to 74 yo
  • 70 to 74 yo are recommended to have an exit HPV test before leaving the cervical screening program.
  • Older women, who are regular screeners will have a protective effect.
  • Women > 69 years of age who have never screened or are lapsed screeners should be screened if they request a test.

Opportunities

  • Less frequent testing and more lives saved
  • Better participation – invitations, recalls + targeted self-collect
  • Future proofing cervical screening – HPV vaccinated cohort
  • Improved registry functions
  • Improved data collection – CALD, indigenous, colposcopy
  • Improve evaluation of National HPV Vaccination Program + National Cervical Screening Program.
  • Continued Leadership and Innovation
    • 1st HPV vaccine,
    • 1st national HPV school based immunisation program,
    • 1st national cervical screening using primary HPV test

Next Steps

  • More consulting
  • Communications Plan
  • Implementation Plan

Questions????

Info:

MSAC website
Cancer Screening website
Email us

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