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General Information

Renewal of the National Cervical Screening Program

Overview of the NCSP Renewal

The Renewal of the NCSP will ensure all Australian women have access to a cervical screening program that is safe, effective, efficient and based on current evidence.

Further information on the Renewal is available on the National Cervical Screening Program website.

Medical Services Advisory Committee (MSAC) Recommendations

The MSAC provided recommendations on new approaches to cervical screening in Australa and the Australian Government accepted the MSAC recommendation to replace the two-yearly Pap test with five-yearly primary HPV tests.

Further information is available on the Department of Health website at Medical Services Advisory Committee recommendations.

Future Changes to Cervical Screening

The Department of Health website outlines the Future Changes to Cervical Screening

The New Program - Overview

The Medical Services Advisory Committee (MSAC) has recommended for both HPV vaccinated and unvaccinated women:

  • five-yearly cervical screening using a primary human papillomavirus (HPV) test with partial HPV genotyping and reflex liquid-based cytology (LBC) triage, for women 25 to 69 years of age, with exit testing of women up to 74 years of age;
  • self-collection of an HPV sample, for an under-screened or never-screened woman, which has been facilitated by a medical or nurse practitioner (or on behalf of a medical practitioner) who also offers mainstream cervical screening; and
  • invitations and reminders to be sent to women 25 to 69 years of age, and exit communications to be sent to women 70 to 74 years of age, to ensure the effectiveness of the program;

MSAC noted:

  • An HPV test every five years is more effective at protecting against cervical cancer and is just as safe as screening with a Pap test every two years.
  • An HPV test every five years can save more lives and women would need fewer tests than in the current two-yearly Pap test program.
  • HPV vaccinated women will still require cervical screening as the HPV vaccine does not protect against all the types of HPV that cause cervical cancer.

Further information on the MSAC recommendations is available on the MSAC website.

National Cancer Screening Register

A new National Cancer Screening Register (NCSR) will replace the current state-based cervical screening registers. Legislation will be introduced to establish the NCSR to facilitate invitation and recall of women to encourage participation in the new NCSP. It will include provisions to allow individuals to opt off and defer or suspend participation in the program, as well as request that their personal information not be disclosed for certain purposes. It will also provide authorisation to state and territory governments that can enable data migration from the existing state-based registers.

The Department of Health has appointed Telstra Health to develop and operate the new National Cancer Screening Register (the Register) to support the renewed NCSP and the expansion of the National Bowel Cancer Screening Program.

Planning and Governance

Planning for the Renewal of the National Cervical Screening Program (NCSP) has required the engagement and cooperation of numerous Commonwealth and State government departments with input and advice from health and other experts and wide-ranging feedback from a broad range of stakeholders. Governance of the transition process and the ongoing monitoring of the new NCSP is provided by a number of groups and committees.

The following is a summary of the main planning and governance bodies:

Australian Health Ministers’ Advisory Council (AHMAC) - the advisory and support body to the COAG Health Council which considers matters relating to the co-ordination of health services across the nation.

Standing Committee on Screening (SCoS) - a committee of AHMAC responsible for overseeing the NCSP Renewal and the establishment of the National Cancer Screening Register.

Medical Services Advisory Committee (MSAC) - an independent expert committee that provides advice to the Minister for Health. Recommendations made by MSAC to AHMAC regarding the evidence and modelling evaluation of potential screening pathways, tests and screening intervals were endorsed in September 2014. MSAC is currently considering MBS item descriptors and associated fees for the new NCSP, which are expected to be publicly released in mid-2016.

For further information regarding the MSAC recommendations go to Recommendations.

Renewal Steering Committee - (now disbanded) provided guidance for the first two phases of the Renewal including assessment of the evidence and modelling evaluation of potential screening pathways, tests and screening intervals.

Steering Committee for the Renewal Implementation Project (SCRIP) - provides current guidance of the implementation phase of the Renewal.

Clinical Management Guidelines Working Party (Cancer Council Australia) - responsible for the development of clinical management guidelines for the new NCSP. Draft guidelines were available for public consultation from 15 February 2016 to 15 March 2016.

Cervical Screening Drafting Committee - engaged in drafting the National Pathology Accreditation Advisory Council (NPAAC) performance measures and standards for human papillomavirus (HPV) testing and cervical cytology. Draft performance measures and standards will be released for public consultation in the first half of 2016.

Pathology Workforce Change Steering Committee - established in November 2015 to provide guidance for the RCPA NCSP Pathology Workforce Project.

Cervical Renewal Taskforce - based within the Commonwealth of Australia Department of Health and acts as the NCSP Renewal Secretariat. The Taskforce is responsible for coordinating and administering the various activities of the Renewal process, including the provision of stakeholder information and collation of feedback via the Partner Reference Group. For further information go to: cancerscreening.gov.au.

Partner Reference Group - an independent, broad based group of individuals and organisations with an interest in cervical screening. Membership is open to all and members receive regular e-newsletters regarding the progress of the NCSP Renewal. To request the newsletter and find out more about the NCSP Renewal contact CervicalRenewal@health.gov.au.

Quality and Safety Monitoring Committee - reports directly to SCoS and has been established to monitor and provide advice on the safety and quality aspects of the NCSP Renewal and to provide advice regarding new statistical analyses for monitoring ongoing safety and efficacy of the new NCSP.

Basic Information for Cytologists on HPV Testing in Primary Screening

The Role of Human Papillomavirus (HPV) in the Pathogenesis of Cervical Cancer

HPV is a small, double-stranded DNA virus. There are more than 200 genotypes of HPV and about 50 of these can infect the genital tract. Of those, fourteen are classed as “high-risk” oncogenic genotypes because of their association with the development of cervical abnormalities and cancer. Types 16 and 18 are associated with 70-80% of high grade cervical lesions and there is some evidence to suggest that these are associated with a higher risk of developing high grade CIN than other oncogenic genotypes.

For further information about HPV please refer to the World Health Organisation website WHO HPV and for the most recent WHO Position Paper on HPV and vaccination refer to WHO HPV vaccination.

Additional information is presented in this recent Webinar by Dr Michael Thomas.

Testing for HPV

Molecular testing for high risk HPV has been used in Australia for many years as a “test-of-cure” following treatment of high grade cervical intraepithelial neoplasia. In that context, the sensitivity and high negative predictive value of the test provides confidence that persistent infection by high risk HPV has been eradicated by treatment and the woman may return to the normal screening program.

In order to replace the Pap smear in primary screening, the test must be at least as sensitive as the Pap smear for the presence of high grade cervical disease. HPV tests being used as part of the new NCSP must be clinically validated for population based primary screening.

In recommending molecular testing for HPV as a primary screening tool the Medical Services Advisory Committee (MSAC) has stated that 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.

The Meijer Guidelines

The Medical Services Advisory Committee (MSAC) has recommended that for HPV testing within the National Cervical Screening Program the guidelines developed by *Meijer et al (2009) should be used to validate the tests used.

MSAC further recommended that the laboratory standards should include sensitivities and specificities based on those developed in the Meijer et al guidelines (clinical sensitivity for ≥CIN2 not less than 90% of the clinical sensitivity of the HC2 and clinical specificity for ≥CIN2 not less than 98% of the clinical specificity of the HC2).

* Meijer CJ1, Berkhof J, Castle PE, Hesselink AT, Franco EL, Ronco G, Arbyn M, Bosch FX, Cuzick J, Dillner J, Heideman DA, Snijders PJ. Guidelines for human papillomavirus DNA test requirements for primary cervical cancer screening in women 30 years and older. Int J Cancer. 2009 Feb 1;124(3):516-20.

The National HPV Vaccination Program

Since January 2007, the Australian Government has funded vaccination against HPV types 16 and 18 for 12 to 13 year old girls with “catch-up” vaccination available for older adolescents and young women for the first few years of the program. In 2013 boys also commenced HPV vaccination. The HPV Vaccination Program aims to prevent about 70 per cent of all HPV infections that are known to cause cervical cancer. Vaccination coverage is high and the program is already beginning to alter the epidemiology of high grade cervical lesions in Australia.

The National HPV Vaccination Program Register (NHVPR) supports the National HPV Vaccination Program and plays an essential role in monitoring and evaluating the program by recording information about HPV vaccine doses administered in Australia.

For further information on the National HPV Vaccination Program Register and the extent of HPV vaccination in Australia go to NHVPR.