Monday 29 May 2017: The Health Information and Quality Authority (HIQA) has advised that CervicalCheck – Ireland’s National Cervical Screening Programme changes its primary screening method to HPV testing. HIQA carried out a health technology assessment (HTA) to assess the impact of changing from the current policy of primary screening with liquid-based cytology to primary screening with HPV testing.

Today’s Health technology assessment (HTA) of human papillomavirus (HPV) testing as the primary screening method for prevention of cervical cancer found that changing to primary HPV testing would reduce the number of screenings each woman has in her lifetime, while providing better accuracy in detecting precancerous abnormalities and early stage invasive cervical cancer. Women would experience no change in how the cervical screening sample is collected.

HIQA’s Director of Health Technology Assessment and Deputy Chief Executive Dr Máirín Ryan said: “HPV infection is associated with almost all cervical precancerous abnormalities and invasive cervical cancers. Compared with the current screening strategy, primary HPV screening is a better test which allows all women who participate in cervical screening to become aware of their current HPV status and those who are at higher risk of cervical cancer to be picked up earlier.”

“Where a woman is found to be HPV-positive following primary HPV screening, a follow-up test using liquid-based cytology will be carried out on that same sample to inspect for cellular abnormalities. If any abnormalities are detected, a more detailed examination of the cervix (colposcopy) is needed. Women with a negative HPV test can be reassured that they are at very low risk of developing precancerous abnormalities in the next five years. For this reason, we advise that the interval between screenings can be increased to every five years for those currently being screened three-yearly. A change to primary HPV screening means the same benefit is provided to women in fewer screenings.”

Implementing primary HPV screening five-yearly from age 25 to age 60 would lead to two fewer screening tests over a woman’s lifetime. Twenty percent more precancerous abnormalities would be detected and 30% more cervical cancer cases and deaths would be avoided for every screening test carried out compared with the current screening strategy.

“As HPV infection is more common in younger women, women who have not been vaccinated against HPV and who are aged between 25 and 30 years may benefit from three-yearly screening to ensure they are protected.”

Dr Ryan continued: “CervicalCheck began in 2008 and there has been good uptake with four in five eligible women up to date with their smear tests. However, this decreases with age. For this reason, HIQA advises that cervical screening may be extended up to 65 years of age for women who have only had the benefit of routine cervical screening from age 50. While this would come with an increased cost, it would provide additional clinical benefit for these women.”

In 2018, the first women vaccinated against HPV 16 and HPV 18 as part of the national school-based immunisation programme will become eligible for CervicalCheck. These women are at lower risk of developing cervical cancer.

However, as the current vaccine does not protect against all virus types that can lead to cervical cancer, vaccinated women should still attend for regular cervical screening.

Dr Ryan said: “Vaccinated women should be screened every five years with HPV testing, as it is the best strategy in this group.

This report was approved by the Board of HIQA and will now be submitted to CervicalCheck - Ireland’s National Cervical Screening Programme and the Minister for Health to inform decision-making about the screening programme. HIQA’s advice is that:

• the sequence of screening tests should be changed to primary HPV screening with liquid-based cytology follow-up testing.
• all eligible women aged 25 to 60 years should be screened every five years, including those vaccinated against HPV 16 and HPV 18.
• however, women aged under 30 years who have not been vaccinated against HPV could be provided with three-yearly primary HPV screening, as HPV infection is more common in this age group.
• screening coverage could be extended up to age 65 years for women who have only had access to CervicalCheck from age 50. Given the lower uptake of screening in older women, this should occur alongside a targeted campaign to maximise uptake of screening in those over 60.

Dr Ryan concluded: “Implementation of our advice to CervicalCheck has the potential to increase benefits for all women and lower costs compared with the current screening programme, freeing resources for use elsewhere in the healthcare system.”

Ends.

For further information please contact:

Marty Whelan, Head of Communications and Stakeholder Engagement 01 814 7480 / 086 244 7623 mwhelan@hiqa.ie

Notes to the Editor:

• This health technology assessment (HTA) was carried out following a request by CervicalCheck - Ireland’s National Cervical Screening Programme, which forms part of the Health and Wellbeing Division of the Health Service Executive (HSE).
• Human papillomavirus (HPV) is a sexually transmitted infection, with skin-to- skin genital contact sufficient for transmission. Cervical cancer results from persistent infection with certain strains of the HPV virus (so called, high-risk HPV strains). The majority of women clear the infection spontaneously. Cervical cancer arises when HPV is transmitted, the virus persists, persistently infected cervical cells progress to precancerous abnormalities and finally to invasive cervical cancer.
• There are two complementary approaches for the prevention of cervical cancer: primary prevention through vaccination against HPV infection, and secondary protection through cervical screening to detect and treat precancerous abnormalities.
• Between 2007 and 2014, data from the Central Statistics Office (CSO) shows there were 707 deaths in Ireland from invasive cervical cancer, an average of 88 deaths per year.
• Cervical cancer is the eighth most commonly diagnosed cancer (excluding non-melanoma skin cancer) in women in Ireland. Irish data from 2012 to 2014 indicate that, on average, 2,873 women were diagnosed with cervical carcinoma in situ and 277 women were diagnosed with invasive cervical cancer each year. Based on these data, 1 in 13 women will be diagnosed with cervical carcinoma in situ in their lifetime (up to age 74), 1 in 112 will be diagnosed with invasive cervical cancer and 1 in 333 will die from cervical cancer.
• CervicalCheck – Ireland’s National Cervical Screening Programme was established in 2008. Screening is provided at three-yearly intervals for women aged between 25 and 44 years. Women between the ages of 45 and 60 years are offered screening at five-yearly intervals. CervicalCheck uses primary liquid-based cytology screening to detect cytological (cellular) abnormalities. HPV triage of low-grade cytological abnormalities was introduced in May 2015, with these women only requiring referral to colposcopy if HPV-positive. 
• A recommendation to switch from primary cytology screening to primary HPV screening is in keeping with developments in other high-income countries. Australia, Italy, Netherlands, New Zealand, Sweden and the UK have all recommended the implementation of primary HPV screening. The Netherlands began using primary HPV cervical screening in January 2017. Extending the screening interval to every five years is also consistent with recent recommendations in Australia and New Zealand.
• There would be no change to the way the cervical screening sample is collected, so the screening experience would be the same for the woman. Both the primary HPV test and liquid-based cytology triage test (if needed) can be completed using the same sample.
• Primary HPV screening with liquid-based cytology triage testing at five-yearly intervals from age 25 to 60 years was identified as the best possible strategy in the context of a willingness-to-pay threshold of €20,000 to €45,000 per quality-adjusted life year (QALY), with an incremental cost-effectiveness ratio (ICER) of €29,788 per QALY.
• Changing to primary HPV screening followed by liquid-based cytology triage testing at five-yearly intervals from age 25 to 60 would result in a net saving of up to €3 million for the cohort of women vaccinated against HPV 16 and HPV 18, €32 million for the unvaccinated cohort, and up to €35 million for the whole CervicalCheck population over an eight-year period from 2018 to 2025.