Australia has established a new cervical screening process based on recommendations by Australia’s independent Medical Services Advisory Committee (MSAC).
Australia has established a new cervical screening process based on recommendations by Australia’s independent Medical Services Advisory Committee (MSAC).
The new Cervical Screening Test has replaced the existing Pap test. MSAC recommended that the new screening test will be conducted every five years instead of every two for people aged 25 to 74 years.
This clinical update provides information on the changes to the National Cervical Screening Program (NCSP) for healthcare providers from 1 December 2017.
From 1 December 2017
A five yearly Cervical Screening Test will replace the two yearly Pap test.
• Women who are already having Pap tests should have their first Cervical Screening Test when they are next due for a Pap test (this is usually two years after their most recent Pap test for those women with a normal screening history)
• Women who have ever been sexually active should have a Cervical Screening Test every five years
• Women will be invited to start cervical screening from the age of 25 and continue screening until they are 74 years
• Women should have an exit test between 70 and 74 years of age
• Women who have been vaccinated against human papillomavirus (HPV) need to have regular cervical screening as the vaccine protects against some high-risk types of HPV, but does not protect against all oncogenic types
• Healthcare providers will still perform a vaginal speculum examination and take a cervical sample, but the sample medium is liquid-based for partial HPV genotyping
• The new Cervical Screening Test will be supported by a new National Cancer Screening Register that will send invitations and reminder letters to women when they are next due, and follow up letters when women have not attended further investigations or tests
The link between HPV and cervical cancer
Nearly all cervical cancers are caused by a HPV infection. HPV is easily transmitted via skin contact during sexual activity. It is extremely common in men and women who have ever been sexually active, with most people being infected with at least one type of HPV at some point in their life. While HPV infections are normally cleared naturally by the immune system, sometimes they cause cervical cells to become abnormal. The body is usually able to rid itself of HPV and the abnormal cells, but in some cases this doesn’t happen and the abnormal cells develop into cervical cancer. The time from HPV infection to cervical cancer is usually 10-15 years.
What is the new cervical screening test?
The Cervical Screening Test detects infection with human papillomavirus (HPV). Partial genotyping is used to determine the type of HPV into one of two groups: oncogenic HPV 16/18 or oncogenic HPV types other than 16/18 as a pooled result.
Reflex liquid-based cytology (LBC) is applied to all HPV positive samples and is used to triage women who test HPV positive for types other than 16/18.
Based on the test result
• women who test negative for HPV will be invited to screen again in five years (low risk)
• women who test positive for high-risk HPV (types 16 and/or 18) are referred to colposcopy regardless of their reflex LBC result (higher risk)
• women who test positive for other types of HPV, the reflex LBC result is used to determine management as follows:
• a possible or definite high-grade squamous intraepithelial lesion (HSIL) and/or any possible or definite glandular abnormality will be referred to colposcopy (higher risk)
• negative cytology or a possible or definite low-grade intraepithelial lesion (LSIL) will be referred for a repeat Cervical Screening Test in 12 months (intermediate risk)
Why are the changes taking place?
Between 2012 and 2014, MSAC assessed an extensive range of clinical evidence and modelling of potential screening pathways. MSAC made a recommendation for the new Cervical Screening Test and pathway.
The New Cervical Screening Test and pathway
• The new Cervical Screening Test every five years is more effective than and just as safe as, a Pap test every two years
• The new Cervical Screening Test and pathway is a risk-based approach to management of women participating in the program. Women are managed according to their risk of developing cervical cancer which is determined by the Cervical Screening Test results
• HPV testing for cervical screening is more sensitive than cytology (Pap tests) and detects the potential for progression to high-grade lesions earlier, thus preventing more cervical cancers
• The Cervical Screening Test detects infection with human papillomavirus (HPV). Partial genotyping is used to determine the type of HPV into two groups: oncogenic HPV 16/18 or oncogenic HPV types other than 16/18 as a pooled result
• If HPV is detected the laboratory will automatically, on the same sample, conduct a cytology test to determine if any cervical cell abnormalities are present. This assists in determining the person’s risk rating and triaging for colposcopy.
Cause of cervical cancer
Cervical cancer is a rare outcome of persistent infection with high-risk HPV types. Infection with a high-risk HPV type is necessary, although not sufficient, for the development of cervical cancer. HPV types 16, 18 and 45 are most predominantly associated with cervical cancer, with types 16 and 18 detected in 70–80% of cases in Australia.
The time from HPV infection to cervical cancer is usually 10-15 years.
What do I say to women who ask about cervical cancer not caused by HPV?
More than 99% of cervical cancers are caused by HPV, which includes squamous cell and adenocarcinoma. A third type of cervical cancer is called neuroendocrine or small cell cervical cancer. These are often more aggressive, but account for less than 1% of cervical cancers. Neither the Pap test nor the new Cervical Screening Test effectively detects neuroendocrine cancers.
Cervical Screening Test
HPV testing for cervical screening is more sensitive than cytology (ie. Pap tests) and detects the potential for progression to high-grade lesions earlier, thus preventing more cervical cancers.
Screening using HPV testing also has the potential to improve detection of adenocarcinoma and its precursors.
While self-collection of samples is possible in some circumstances, it is not recommended for routine screening, as it is not as effective as clinician-collected screening.
How should women transition to the new screening pathway?
Most women will be due for their first Cervical Screening Test two years after their last negative Pap test. Women who are undergoing follow-up investigation or treatment should transition to the new screening pathway as outlined in the 2016 Guidelines found at www.cancer.org.au
Women under 25 years of age will be invited at 25 years of age for their first Cervical Screening Test.
How do I explain why women who have had the HPV vaccine still require cervical screening?
HPV types 16 and 18 cause more than 70% of cervical cancers in Australia. The HPV vaccine protects against both these types; however, it does not protect against other oncogenic types of HPV known to cause cervical cancer. Therefore, vaccinated women are still at risk of cervical cancer from these other high risk HPV types and need to participate in regular cervical screening.
Due to the high negative predictive value of HPV testing, a screening interval of five years is safe for women who are HPV-negative.
What do I say to women who want to screen more often than every five years?
The Cervical Screening Test is more effective at preventing cervical cancers than the Pap test. Cervical cancer usually takes 10 to 15 years to develop from an HPV infection, so it is very unlikely that cancer will develop in the five years following a negative Cervical Screening Test. Studies have shown that the chance of developing high-grade cervical abnormalities after a negative Cervical Screening Test is lower than the chance of developing them after a negative Pap test.
Because Australia has an effective national vaccine program, the prevalence of HPV in young people 18-24 is very low.
Cervical cancer in young women (under 25 years of age) is rare, and screening has not changed the rates of incidence or mortality from cervical cancer in this age group. Commencing screening at age 25 will reduce the investigation and treatment of common cervical abnormalities that would usually resolve by themselves in women under the age of 25. In addition, the HPV vaccine has been shown to reduce cervical abnormalities in young women.
Sending an invitation for women to have a final HPV test between the ages of 70–74 years, rather than 64–69 years, is expected to reduce the incidence of cervical cancer by 4%, and mortality from cervical cancer by 7%.
Women of any age with symptoms, such as unusual bleeding or spotting, will be able to have a Cervical Screening Test.
What do I say to women who are nervous about waiting until 25 to screen?
Screening women younger than 25 years has not reduced the number of cervical cancer cases, or deaths from cervical cancers, in this age group. Cervical cancer is rare in women younger than 25 years.
While HPV infection and cervical abnormalities are common in women younger than 25, both usually clear up without needing treatment. Treatment of these common abnormalities can increase the risk of pregnancy complications later
What if I’m concerned that a woman engaged in sexual activity at a very young age?
For women who experienced their first sexual activity at a young age (before age 14) and had not received the HPV vaccine before this, a single Cervical Screening Test between the ages of 20–24 years could be considered on an individual basis.
How will women know when they are due for their Cervical Screening Test?
The new National Cancer Screening Register (NCSR) will provide an invitation, reminder and recall system to prompt women to book an appointment, supporting and promoting timely participation in cervical screening.
The new National Cancer Screening Register (NCSR)
The NCSR will be a national database of cancer screening records, including Cervical Screening Test results.
Data collected by the NCSR is protected by legislation and cannot be used for purposes other than to support the operations of the cervical screening program, inform ethics-approved research projects, and report on outcomes at a population level.
How will the NCSR support the NCSP?
The NCSR will support the NCSP by:
• inviting women to commence screening when they turn 25 years
• reminding women when they are due and overdue for cervical screening
• providing a woman’s cervical screening history to laboratories for comparison with current results
• providing a ‘safety net’ for women who have positive test results and who have not attended further testing, by prompting them to have follow-up tests
What do the changes mean for healthcare providers?
Patient reminder and recall systems
Healthcare providers will need to update their practice patient reminder and recall systems in line with the new pathways and screening intervals.
Changes to the Cervical Screening Test
Healthcare providers will still perform an examination using a vaginal speculum and take a sample, but the sample medium is liquid-based and will be tested for the presence of HPV. For the participant, if they have ever had a Pap test before, the way the test is done will feel the same.
For patients that may have refused to screen, an alternate method of collection is available but patients must meet the eligibility criteria; be over 30 years of age and be overdue for their screening test by two years or more.
Changes to MBS items
The Pap test is no longer covered under the Medicare Benefits Scheme (MBS) and will be replaced with the new Cervical and Vaginal Testing and accompanying MBS item numbers. Healthcare providers will need to know the differences between the MBS items and provide as much information on the pathology request form as possible. This will avoid the wrong pathology test being performed on the sample and may result in the patient being charged incorrectly for a test.
Healthcare providers should not write Pap test or smear on the pathology request form, otherwise their patient will be charged. To assist with completing the pathology request please refer to the Pathology test guide for Cervical and Vaginal testing available on the Australian Department of Health website.
How can I get across the changes?
The new screening pathway
The new Cervical Screening Test and pathway is a risk-based approach to the management of HPV and cervical cancer, as recommended by the MSAC. Patients are managed according to their risk of developing significant cervical abnormalities within the next five years, which is determined by their Cervical Screening Test result.
The new Cervical Screening Test is more accurate than cytology alone (ie. Pap tests) as it detects the presence of HPV and the potential for progression to high-grade lesions earlier, thus preventing more cervical cancers. Screening using HPV testing has the potential to improve detection of adenocarcinoma and its precursors.
For clinician collected specimens, reflex LBC can be performed on the same cervical specimen (without requiring an additional request) and the pathology lab will issue the HPV test result, LBC test result and overall screening risk rating as a combined report. Self-collection of a vaginal sample can only be tested for HPV. A new pathology request will be required for the clinician collected specimen for reflex LBC testing only. The pathology lab will then issue a combined report with the initial self-collect HPV test, LBC test result and overall screening risk rating as a combined report.
If any glandular abnormalities are detected on a screening test, healthcare providers should follow up according to the 2016 Guidelines.
There are four result categories:
• Return to screen in five years
• Repeat the HPV test in 12 months
• Refer to a specialist
• Unsatisfactory sample (HPV or LBC) retest within 6-12 weeks
Return to screen in five years
This result means oncogenic HPV was not detected. Patients with this result will be invited to screen again in five years.
These patients are at low risk of developing cervical cancer and can safely return for a Cervical Screening Test in five years.
We cannot assure patients that they are at ‘no risk’ because they may subsequently acquire an HPV infection or have a latent infection that becomes active.
Repeat the HPV test in 12 months
This result means an HPV infection was detected. It is not associated with high-grade cell changes that require treatment.
A reflex LBC conducted on the same sample showed that the patient has negative or possible low-grade squamous intraepithelial lesion (LSIL), or LSIL abnormal cervical cells.
These patients will be invited to return for a repeat HPV test in 12 months. This is to check if the body has cleared the HPV infection.
Refer to a specialist
This result means the patient has received one of two possible results:
• HPV is detected, but not types 16 or 18
A reflex LBC will be conducted on the same sample. If possible high-grade squamous intraepithelial lesion (HSIL) or HSIL on cytology has been detected, the patient should be recommended to a specialist to have a colposcopic assessment because they are at a higher risk of cervical cancer. A colposcopy will determine if a biopsy is needed and treatment is required.
• HPV types 16 or 18 have been detected
HPV types 16 and 18 are associated with approximately 70% of cervical cancers. These HPV types are more likely to progress to cervical cancer than other oncogenic HPV types. Regardless of the reflex LBC test result, the patient should be recommended to have a colposcopic assessment because they are at a higher risk of cervical cancer. The LBC will inform the colposcopic assessment.
Unsatisfactory sample (HPV or LBC) retest within 6-12 weeks
This result means the sample collected was unsatisfactory. If the HPV test was unsatisfactory, the patient should return within 6-12 weeks for a repeat HPV test. If the LBC test was unsatisfactory, the patient should return within 6-12 weeks for a repeat LBC test.
More information for healthcare providers
Healthcare provider information pack
An information pack has been sent to healthcare providers. It contains the essential information about the changes to the National Cervical Screening Program and materials which you can use to explain the changes to your patients.
Alternatively, you can order resources from the publications and resources section of the Australian Department of Health website.
Online training modules
Online training modules to help you understand the new test and Clinical Pathways are available on the NPS MedicineWise website. www.nps.org.au
This training will be recognised as continuing professional development hours with RACGP, ACRRM, ACN, ACM and APNA.
Training covers information about the changes to cervical screening, including:
• The difference between the new Cervical Screening Test and the Pap test
• New results categories and clinical pathways
• Managing people transitioning to the new clinical pathway who have test results and are under clinical management
• Practical advice and videos to help you engage with patients from culturally and linguistically diverse communities and patients with an intellectual disability
The training was developed by the Department of Health and NPS MedicineWise.
Resources available for healthcare providers
Guidelines for the management of screen-detected abnormalities, screening in specific populations and investigation of abnormal vaginal bleeding are available on the Cancer Council Australia wiki website: wiki.cancer.org.au/australia/ Guidelines:Cervical_cancer/Screening
The Clinical Guidelines for the National Cervical Screening Program
Health providers should regularly check for updates in the 2016 National Cervical Screening Program: Guidelines for the management of screen-detected abnormalities, screening in specific populations and investigation of abnormal vaginal bleeding. The latest version is available on the Cancer Wiki platform
Commonwealth of Australia Department of Health. 2017. National Cervical Screening Program. For Healthcare Professionals. Canberra: Australian Government Department of Health
To read more articles from ANMJ, view the full journal online at https://issuu.com/australiannursingfederation/docs/anmj_march_18_issuu