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HTA of HPV testing for cervical cancer screening

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Foreward

Following a request from the National Screening Service, the Health Information and Quality Authority (HIQA) agreed to undertake a health technology assessment (HTA) of human papillomavirus testing as the primary screening method for the prevention of cervical cancer in Ireland. The assessment was completed and submitted as advice to the Minister for Health and the National Screening Service for consideration.

Purpose

CervicalCheck – Irelands National Cervical Screening programme currently uses liquid-based cytology as the primary screening test for the detection of precancerous cervical abnormalities and early stage cervical cancer. The purpose of the HTA is to inform decisions around changing to HPV testing as the primary screening test. Strategies for triage were assessed along with alternative screening intervals and age-bands. The HTA examined the clinical effectiveness, safety, cost-effectiveness and budget impact of different screening strategies, as well as the organisational, societal and ethical implications of any changes to the screening programme.

Background

Cervical cancer is the eighth most commonly diagnosed cancer (excluding non-melanoma skin cancer) in women in Ireland, with on average, 88 deaths from cervical cancer per year. Between 2012 and 2014, on average, 2,873 women were diagnosed with cervical carcinoma in situ (pre-invasive cervical cancer) and 277 women were diagnosed with invasive cervical cancer. These data indicate that 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.

Cervical cancer is associated with persistent infection with human papillomavirus (HPV). Therefore, there are two complementary approaches to preventing cervical cancer: primary prevention through vaccination to prevention HPV infection, and secondary prevention through screening to detect and treat precancerous abnormalities and early stage invasive cervical cancer. Over the last 10 years, increasing evidence has become available that, when used as a primary screening test, HPV testing can improve the accuracy of cervical screening compared with cytology-based testing for the prevention of cervical cancer.

Methodology

This research was carried out in accordance with HIQA’s guidelines for the conduct of health technology assessments. The Terms of Reference of the HTA were agreed between HIQA and the National Screening Service. An Expert Advisory Group was convened, with representation from health policy decision-makers, clinicians, patient advocates, professional bodies and experts in health services research and economic evaluation. An evaluation team was appointed comprising HIQA staff.

Two systematic reviews of the clinical literature were carried out. The first looked at the comparison of HPV testing with cytology testing as the primary screening method for cervical cancer. The second looked at triage options for HPV based primary screening, 

An economic evaluation was performed to estimate the cost-effectiveness and budget impact of different screening strategies for women vaccinated against HPV 16 and HPV 18 and those not vaccinated.

An analysis of the organisational, social and ethical implications of changes to the cervical screening services was carried out to identify broader considerations that may influence decision-making.

The complete draft report was reviewed by the Expert Advisory Group before being submitted the National Screening Service and the Minister for Health as advice.

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