HPV testing for primary cervical screening This Medicine Update is to inform women about planned changes to the National Cervical Screening Program. Summary Most cases of cervical cancer are caused by persistent (ongoing) infection with certain types of genital human papillomavirus (HPV). HPV testing of cervical cells can help to identify women at risk of cancer very early on often before the cells have changed. HPV-vaccinated women should continue to undergo cervical screening. From May 2017 the following changes will be introduced to the National Cervical Screening Program: HPV testing will replace the current Pap smear as the primary screening method the new cervical screening test detects HPV infection, which is the first step in developing cervical cancer. The frequency for testing will be extended from two years to five years, if the sample is HPV negative clinical trials have confirmed that an extended interval between HPV tests is appropriate and safe. The starting age for screening will increase from 18 years to 25 years HPV infections are highly prevalent and often transient in young women. Evidence is lacking that cervical screening is effective in women younger than 25 years. Until May 2017, eligible women aged 18 69 years should continue to have cervical screening according to the current program arrangements. An MBS subsidy for the new test will come into effect from May 2017. Date published: October 2015 Independent, not-for-profit and evidence-based, NPS MedicineWise enables better decisions about medicines and medical tests. We receive funding from the Australian Government Department of Health.
Contents section What is cervical cancer?...1 What can cause cervical cancer?... 2 What do we know about HPV testing?... 3 How is the National Cervical Screening Program changing?... 4 What else do I need to know about the renewed screening program?... 5 For more information... 6 References... Back page Asking the right questions about new medicines and medical tests What is Medicine Update? Medicine Update provides independent information about new medicines and new listings on the PBS. It tells you about the possible benefits and risks of new medicines or medical tests, who can and can t use them, and some of the other treatment options available. How to use Medicine Update Medicine Update is a tool to help you understand your treatment choices and to discuss them with your health professional. Medicine Update doesn t describe all possible side effects, precautions, or interactions with other medicines so you should always read the consumer medicine information (CMI). Who is it for? Medicine Update is for anyone who is taking, or thinking of taking, a new medicine or medical test. Where does Medicine Update come from? Medicine Update is written by NPS MedicineWise in consultation with consumers and health professionals. NPS MedicineWise is independent, not-for-profit and evidence based. 2015 National Prescribing Service Limited (NPS MedicineWise). Reasonable care is taken to provide accurate information at the time of creation. This information is not intended as a substitute for medical advice and should not be exclusively relied on to manage or diagnose a medical condition. NPS MedicineWise disclaims all liability (including for negligence) for any loss, damage or injury resulting from reliance on or use of this information. 2
1. What is cervical cancer? The cervix is a part of the female reproductive system. It is located at the junction between the lower part of the uterus and the upper internal wall of the vagina. Under certain conditions cells of the cervix can undergo abnormal changes and begin to multiply out of control. If these altered cells are not detected and treated, tumours can develop and spread into the surrounding tissues. How common is cervical cancer? In Australia the burden of cervical cancer is low. Around 700 women were diagnosed with cervical cancer in 2011 and 143 women died from the disease in 2012. 1 The rates of new cases and deaths have remained largely unchanged for the past decade. 1 In contrast, worldwide data show that cervical cancer affects a lot of women, with an estimated half a million new cases diagnosed in 2012 and an annual mortality of 270,000. 2 Around 85% of the global burden occurs in less developed regions. 2 Why is Australia doing so well? The low incidence of new cervical cancer cases and deaths is largely attributed to the National Cervical Screening Program (NCSP), established in 1991 by Australian, State and Territory governments. Current rates are half what they were when the NCSP first started. 1 The program encourages early detection (screening) and treatment of cervical cell abnormalities in women aged 18 70 years who have ever been sexually active, to reduce their risk of developing cervical cancer. Around 700 Australian women were diagnosed with cervical cancer in 2011 and 143 women died from the disease in 2012. Current rates are half what they were when the NCSP first started. 2. What can cause cervical cancer? Almost all cases of cervical cancer are the result of persistent (ongoing) infection with HPV, which is short for 1, 3-5 human papillomavirus. What is HPV? HPV is a commonly occurring wart virus that is spread 2, 3, 6 through direct skin-to-skin contact. Over 100 different (geno)types of HPV have been identified and about 40 of these can infect the skin and membranes of the genital area in men and women. 3, 7 It has been estimated that 4 out of 5 people will have a genital HPV infection at some time in their lives. 3, 8, 9 Among women, HPV infection rates tend to be highest in young adulthood (typically between the ages of 15 and 25 years). 1, 9 Although common, most genital HPV infections have no symptoms and are cleared from the body by the immune system within a year, so many people will be unaware they are infected. 1-3 Almost all cases of cervical cancer are the result of persistent (ongoing) infection with HPV. It has been estimated that 4 out of 5 people will have a genital HPV infection at some time in their lives. 3
What is the link between HPV and cervical cancer? When HPV remains in the body for long periods of time, infected cells can undergo change. Depending on the type of HPV infection, these changes might cause genital warts and other benign conditions. More rarely the changes can 2, 3, 6, 10 lead to cancer. There are about 15 HPV types that are described as highrisk that is, they are cancer-causing. 1, 11 In Australia, the genotypes HPV 16 and HPV 18 have been detected in 70% 80% of cervical cancer cases. 12 Most women infected with HPV (including types like 16 and 18) will not go on to develop cervical cancer, even women who already have changes that make their cervical cells 11, 13, 14 more cancer-like (precancerous). This is because it takes decades for abnormal cervical cells to grow and become cancerous, and during this time the immune system may be able to clear the virus, allowing the 11, 14 altered cells to return to normal (regression). However, for a small number of women, having a longterm HPV infection, in addition to other factors such as smoking, other sexually transmitted infections or long-term use of the contraceptive pill, may influence the likelihood that infected cells become precancerous and then go on to 1, 3, 11, 15, 16 become cancer. About 15 HPV types are described as high-risk. Most women infected with HPV will not go on to develop cervical cancer; for a small number of women, having a long-term HPV infection may influence the likelihood that infected cells become precancerous. 3. What do we know about HPV testing? An HPV test is a laboratory-based test used to detect the presence of human papillomavirus in a cervical tissue sample. There are many different types of HPV tests available. In Australia, HPV tests are currently recommended as part of follow up for women who needed treatment after a Pap 1, 17 smear identified (high-grade) abnormal cells in their cervix. The HPV tests for the National Cervical Screening Program (NCSP) will include partial genotyping that is, they will be able to identify if certain high-risk HPV types (eg, 16, 18 and possibly 45) are present in the sample. 18 These high-risk genotypes account for more than 70% of all cervical cancers. Identifying women infected with highrisk HPV early, using HPV testing, can provide 60% to 70% greater protection against invasive cervical cancers compared with a Pap smear. 19 Are there risks with HPV tests? As with any screening test, an HPV test carries the risk of false-positive or false-negative results. A false-positive test result means the test shows a person has a high-risk type of HPV when they don't. A false-positive result could lead to an unnecessary follow-up procedure, such as colposcopy or biopsy, and undue anxiety over the test results. A false-negative test result means a person has an HPV infection, but the test does not show this. This might cause a delay in appropriate follow-up tests or procedures. Identifying women infected with high-risk HPV early, using HPV testing, can provide 60% to 70% greater protection against invasive cervical cancers compared with a Pap smear. As with any screening test, an HPV test carries the risk of false-positive or false-negative results. 4
Studies have confirmed that if an HPV test result is negative, then the test was accurate 99% of the time. 16 This level of confidence in a result gives support to the decision by the Medical Services Advisory Committee (MSAC) to recommend the interval between HPV tests be increased to 5 years (see below How is the National Cervical Screening Program changing?) In addition, other trials have also confirmed that less frequent HPV testing is as safe and efficient in identifying women not at risk of abnormal cellular changes as a more frequent Pap test. 20-22 Another risk that has been associated with HPV testing is the risk of overdiagnosis and overtreatment for abnormal cell changes that would have gone away on their own. Trials have also confirmed that less frequent HPV testing is as safe and efficient in identifying women not at risk of abnormal cellular changes as a more frequent Pap test. This risk may be particularly high among younger women aged < 25 years 16, 23 because HPV infections are common in this group 24 but they are not at high risk of death, suggesting the infections are often transient. 1 In addition, there is no evidence, in Australia or internationally, that cervical screening in women under 25 years is effective or leads to reduced mortality from cervical cancer. To address this risk, MSAC has recommended that the starting age for screening under the renewed program will be 25 years. 18 4. How is the National Cervical Screening Program changing? From May 2017, the National Cervical Screening Program and the way Australian women are being screened for cervical cancer will undergo some significant changes. These changes reflect the many developments that have taken place within the cervical cancer field, particularly in understanding of the role of HPV infection in the development of the disease. Key changes to the screening program will include: 18 replacing the current screening method, a Pap test (or smear), with an HPV test extending the time between screening tests from 2 to 5 years for women who have a negative HPV test increasing the age when screening starts from 18 years to 25 years allowing women who have not attended screening regularly, or ever, to self-collect a vaginal sample. Before the changes were recommended, MSAC conducted an extensive review of the available evidence on the safety, clinical effectiveness and cost-effectiveness of using HPV testing in this new way. 18 What is MSAC? MSAC is an independent expert committee which provides evidence-based advice to the Minister for Health on supporting new or existing medical services or devices through the Medical Benefits Scheme (MBS). You can find out more about MSAC at www.msac.gov.au. 5
How do these changes benefit me? If you are a woman who will be between 25 and 74 years old in May 2017, then you will be eligible to take part in the renewed National Cervical Screening Program. MBS subsidies will be made available in May 2017 when the renewed program is introduced. HPV testing is as safe as a Pap smear, and more effective at early detection of abnormal cervical changes. 18 Instead of detecting the cellular changes through the Pap smear, HPV testing will allow for early identification of women who are at higher risk of developing cancer, so they can be monitored more closely and treated when necessary. If you have a negative result, you will not need to be screened as often you will be sent an invitation for screening in five years time. This means fewer screening tests over your lifetime, from 26 with Pap smears down to 9 or 10 with the new program. If you have an abnormal test result, your doctor will advise the type of follow-up you require, which could be further testing or specialist referral for further investigation. 5. What else do I need to know about the renewed screening program? Keep having your regular Pap tests Until the new program is started in 2017 it is important that you still have your regular 2-yearly Pap smear if you are aged 18 69. For more information about the current screening program call 13 15 56 or go to the website: www.cancerscreening.gov.au Being vaccinated does not exclude you from the program You still need to participate in cervical screening, even if you have been vaccinated for HPV the vaccine does not protect against all the types of HPV that cause cervical cancer. Until the new program starts in 2017, it is important that you still have your regular 2-yearly Pap smear if you are aged 18 69. Being vaccinated does not exclude you from the program, now or after the changes have aken effect. Self collection will be available Some women do not currently participate in cervical screening for cultural, religious or geographical reasons. As part of the renewed NCSP, women who have never been screened, or do not attend regular screening, will be able to perform self collection under the guidance of a medical or nurse practitioner or other health professional who offers mainstream cervical screening. 18 This option is important because it is estimated that 50% of cervical cancers occur in women who have never been screened, and that another 28% develop among women who have waited longer than the recommended two years to receive screening. 1 6
6. For more information Information over the phone Call Medicines Line on 1300 MEDICINE (1300 633 424) for information about your prescription, over-the-counter and complementary medicines (including herbal, 'natural', vitamins and mineral supplements) from a pharmacist. Your call will be answered by healthdirect Australia. Call from anywhere in Australia for the cost of a local phone call (calls from mobiles may cost more), Monday to Friday, 9am to 5pm AEST (excluding NSW public holidays). Information online The Department of Health website (www.health.gov.au) has more information on the current program and the future changes that will be made to cervical screening from May 2017. To report a medicine side effect Call the Adverse Medicine Events (AME) Line on 1300 134 237 (Monday Friday, 9am 5pm EST). The AME Line lets you report and discuss side effects that might be related to your medicines. Medicine-related side effects are then reported to the Therapeutic Goods Administration (TGA) for assessment and contribute to national medicine safety efforts. Your personal information will remain confidential and your privacy maintained. More about using medicines wisely Learn how to make wise choices about taking medicines: www.nps.org.au/unused-medicines Read more about side effects and interactions: References www.nps.org.au/side-effects-interactions Australian Self Medication Industry: www.asmi.com.au References available online at nps.org.au/publications/consumer/medicine-update/2015/national-cervical-screening-program-changes Date published: October 2015 The information provided is not medical advice. Do not use it to treat or diagnose your own or another person s medical condition and never ignore medical advice or delay seeking it because of something herein. Medicines information changes, and may not be accurate when you access it. To the fullest extent permitted by law, NPS MedicineWise disclaims all liability (including without limitation for negligence) for any loss, damage, or injury resulting from reliance on, or use of this information. Any references to brands should not be taken as an endorsement by NPS MedicineWise. 2015 National Prescribing Service Limited (NPS MedicineWise). Apart from any such use or otherwise as permitted under the Copyright Act 1968, all rights are reserved. Queries concerning reproduction and rights should be sent to copyright@nps.org.au Independent, not-for-profit and evidence based, NPS MedicineWise enables better decisions about medicines and medical tests. We receive funding from the Australian Government Department of Health. ABN 61 082 034 393 l Level 7/418A Elizabeth Street Surry Hills NSW 2010 l PO Box 1147 Strawberry Hills NSW 2012 Phone: 02 8217 8700 l Fax: 02 9211 7578 l email: info@nps.org.au l web: www.nps.org.au