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Australia has one of the lowest rates of cervical cancer in the world, largely as a result of the success of the National Cervical Screening Program over the last 25 years.
The program is changing based on the latest available evidence on the development and prevention of cervical cancer. The Pap test is being replaced with a Cervical Screening Test. In the past, the two-yearly Pap test looked for changes in the cells of the cervix. The new test looks for the human papillomavirus (HPV) that causes nearly all cervical cancers.
HPV is a common virus transmitted through sexual activity. The body normally clears the virus itself. When it is persistent, cells can change and cervical cancer can develop. This can take more than 10 years. The new test is more effective at detecting women at risk of developing cervical cancer by detecting HPV. Even women who have had the HPV vaccine will need cervical screening because the vaccine does not protect from all the types of HPV that cause cervical cancer.
From 1 December 2017 pathology Medicare Benefits Schedule (MBS) items for cervical screening will change. This will have practical implications for service providers, clinicians, and consumers alike.
Supporting a revised clinical pathway
The MBS items for cervical and vaginal pathology testing for cervical pre-cancer and cancer have been updated to support the revised clinical management pathway and renewed National Cervical Screening Program. There will be seven new MBS item numbers, and the currently used item numbers will be deleted. The renewed National Cervical Screening Program now centres on human HPV testing with partial genotyping, and reflex liquid-based cytology (LBC), where indicated. This will better identify patients at risk of pre-cancerous abnormalities and cervical cancer.2 The purpose of the change is to deliver a more effective program based on current evidence and best practice.
About the changes
There are several major changes to cervical screening practice in the renewed National Cervical Screening Program.
Five-yearly routine Cervical Screening Tests are recommended for asymptomatic patients from 25 up to 74 years of age, with a previously normal screening history. Where HPV is not detected, patients aged 70–74 years are eligible to exit the program. Testing methodology and pathology MBS item numbers have changed. This means that pathology request forms need to be filled in differently from previously, and it is important that the appropriate test name and supporting patient information is written on the request form.
The renewed National Cervical Screening Program will be supported by the new National Cancer Screening Register, and there are new ‘opt out’ procedures for patients.
What do screening providers need to do?
Healthcare service providers need to become familiar with the changes to the National Cervical Screening Program, and how these changes will affect their patients and practice.
A table titled Pathology Test Guide for Cervical and Vaginal Testing provides further information for healthcare providers on pathology test requirements under the renewed National Cervical Screening Program.
Cytology will no longer be used for routine cervical screening, and Pap tests will be replaced by a Cervical Screening Test which is an HPV nucleic acid test with partial HPV genotyping. Partial genotyping is used to classify HPV into either ‘oncogenic HPV 16/18’ or ‘oncogenic HPV types not 16/18’ as a pooled result. If HPV is detected, the pathology laboratory will automatically conduct a reflex LBC test on the same sample, to determine if any cervical cell abnormalities are present.
Reflex testing is timely and cost-effective, and has the advantage of not requiring an additional sample to be obtained from the patient. The pathology report will include the combined results and recommend the appropriate clinical management or follow-up pathway.
Where a patient has had a positive cervical screening test result, a 12-month follow-up HPV test should be requested. Patients undergoing clinical management for a previously abnormal Pap test result should transition to the new pathway in accordance with the 2016 Guidelines for the management of women with screen detected abnormalities, screening in specific populations and investigation of abnormal vaginal bleeding.3
Patients who were recommended to have a 12-month follow-up Pap test should be offered the follow-up HPV test at this time, instead. Patients who have been exposed to diethylstilboestrol (DES) should be offered annual co-testing as per the 2016 Guidelines instead of routine five-yearly screening.
Co-testing with both the HPV and LBC tests should be requested for post-treatment clinical management of patients who have undergone treatment for high-grade squamous intra-epithelial lesions (HSIL) or adenocarcinoma in situ (AIS). The 2016 Guidelines recommend that patients who have received treatment for HSIL should complete ‘Test of Cure’ surveillance before returning to routine screening. This should be performed 12 months after treatment and annually thereafter, until the patient receives negative co-tests on two consecutive occasions. The patient can then return to five-yearly screening. Co-tests are distinct as the pathology laboratory will always perform an LBC in addition to HPV partial genotyping, whereas for routine Cervical Screening Tests, the reflex LBC is dependent on the result of the HPV test.
Follow-up and post-treatment tests are available for patients of any age. If the test results are reported as unsatisfactory, repeat testing is available as a separate pathology item.This is only claimable by the patient if it is preceded by another cervical or vaginal MBS item.
What’s the evidence?
Australia is one of the first countries to adopt the HPV test as part of a nationwide screening program. There is a large body of evidence supporting the use of HPV testing in primary screening and it has been shown in several randomised control trials to be superior to cytology in detecting high-grade abnormalities and cervical cancer.2
What to write on the pathology request form: Follow-up and clinical management
If requesting a 12-month follow-up test for a patient who had a previous positive screening test, the pathology request form should state ‘Follow-up HPV test’. This test is available for patients of any age. Following treatment of HSIL, patients of any age can be referred for a cervical ‘test of cure’. The pathology request form should state ‘Co-test, Test of Cure’ or ‘HPV and LBC, Test of Cure’. Following treatment of AIS, patients of any age can be referred for post-treatment cervical testing.
The pathology request form should state ‘Co-test, Post-treatment’ or ‘HPV and LBC, Post-treatment’. Asymptomatic patients who have been exposed to DES in utero can be referred for cervical testing. The pathology request form should state ‘Co-test, DES’ or ‘HPV & LBC, DES’. When a test is reported as unsatisfactory by the pathology laboratory, repeat testing should be performed and the pathology form should state ‘HPV test, previous result unsatisfactory’ or ‘LBC, previous result unsatisfactory’. The form should also state whether the sample is cervical or vaginal. This test is only claimable if preceded by a prior cervical or vaginal MBS item.
MBS pathology items have changed to reflect structured testing for screening, follow up and clinical management of patients. This means it is very important to provide all of the necessary patient information on the pathology request form, to ensure the appropriate test is applied and the patient is managed accordingly. The patient’s age, previous screening history, medical background and presenting symptoms should all be considered.
Providers will need to specify on the pathology request form:
The table below outlines the new conventions to use when completing pathology request forms.
The renewed National Cervical Screening Program will be supported by the new National Cancer Screening Register. The Register will send invitations and reminder letters to patients three months in advance of their screening due date on behalf of the Program. There will also be changes to the way patients can opt out of the Register.
After 1 December 2017 writing (or placing a sticker) ‘Not for Register’ on the pathology form will no longer be accepted. If a patient chooses to opt out of the Register they can arrange this by calling 1800 627 701. Alternatively, with the consent of the patient, this can be arranged by their healthcare provider or personal representative. Opting a patient out of the Register for cervical screening will not opt them out of other screening programs (such as bowel screening), and they can opt back in at any time by calling 1800 627 701.
One of the components of the renewed National Cervical Screening Program is the introduction of self-collected samples for HPV testing. The self-collection option has been included in the program to encourage women who are aged 30 years or over and have never had a screening test, or who are overdue for testing by at least two years and in either case have declined a healthcare provider-collected sample, to participate in cervical screening.
However, self-collection can only be implemented when the laboratory and platform testing processes and equipment attain the various accreditation requirements. This process is still underway. Laboratories are not yet accredited to perform the test and therefore the test is not claimable against the MBS.
Healthcare providers who conduct cervical screening tests are advised not to offer self-collection to eligible women until further notice. All other aspects of the renewed National Cervical Screening Program will go ahead as scheduled on 1 December 2017.
Further information on the Renewal of the National Cervical Screening Program is available at www.cancerscreening.gov.au/cervical
NPS MedicineWise is an independent, not-for-profit and evidence-based organisation working across Australia and throughout the Asia-Pacific region to positively change the attitudes and behaviours which exist around the use of medicines and medical tests, so that consumers and health professionals are equipped to make the best
decisions when it counts.
1. Commonwealth of Australia Department of Health National Pathology Accreditation Council. Requirements for laboratories reporting tests for the National Cervical Screening Program Canberra: Commonwealth of Australia Department of Health,2017.
2. NPS MedicineWise. Changes to the National Cervical Screening Program. NPS Radar. Sydney: NPS MedicineWise, 2015.