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.
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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
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MSAC Process

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Primary Question

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	Comparator (Current program)	Scenario 1	Scenario 2	Scenario 3
Primary screening test	Conventional cytology	Convention cytology	LBC	HPV DNA testing
Age range	Women aged 18-69 years	Women aged 25-64 years	Women aged 25-64 years	Women aged 25-64 years
Interval	2 yearly	3 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 options	Comparator (Current program)	Scenario 1	Scenario 2	Scenario 3
Additional technology	N/A	N/A	With and without automated image analysis	With and without automated image analysis
Exit strategy	Must have two normal cyctology tests within the last 5 years	HPV DNA test at age 64 years	HPV DNA test at age 64 years	HPV DNA test at age 64 years
Self collection	N/A	N/A	N/A	Yes
Call-recall system	N/A	Yes	Yes	Yes

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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• 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.

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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