Since 1991 in Australia:
- biennial pap tests , 18-69yo
- 50% incidence and mortality
- constant for past decade
- 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.
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.
WhyTop of page
- 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
- Assess the evidence of screening pathways – including tests, interval + age range, for HPV vaccinated and unvaccinated women.
- Determine a cost-effective screening pathway and program model.
- Improve national data collection systems and registry functions.
- Assess the feasibility and acceptability of the renewed program.
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
- 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
- Service Providers
- Consumer Organisations
s + t reps (SCoS + PM)Top of page
Text version of diagram
Text version of diagram
Primary QuestionTop of page
|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)
|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|
- 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 cancerTop of page
Description 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.
- 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.
- the comparative merits of the available HPV test technologies for primary screening and partial genotyping;
- the exit strategy at age 69 years, including HPV infection rates in older women;
- change management, costs and communications;
- presentation of disaggtregated MBS costs;
- further information regarding the potential links of cervical screening registers to the national HPV immunisation register; and
- 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
AdviceTop of page
- 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.
HPV testsTop of page
- 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
- 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.
- 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.
- 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.
- 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
- More consulting
- Communications Plan
- Implementation Plan
Cancer Screening website