Abstract

To evaluate the short-term consequences and cost-effectiveness associated with the use of novel biomarkers to triage young adult women with minor cervical cytological lesions. Model-based economic evaluation using primary epidemiological data from Norway, supplemented with data from European and American clinical trials. Organised cervical cancer screening in Norway. Women aged 25-33 years with minor cervical cytological lesions detected at their primary screening test. We expanded an existing simulation model to compare 12 triage strategies involving alternative biomarkers (i.e. reflex human papillomavirus (HPV) DNA/mRNA testing, genotyping, and dual staining) with the current Norwegian triage guidelines. The number of high-grade precancers detected and resource use (e.g. monetary costs and colposcopy referrals) for a single screening round (3 years) for each triage strategy. Cost-efficiency, defined as the additional cost per additional precancer detected of each strategy compared with the next most costly strategy. Five strategies were identified as cost-efficient, and are projected to increase the precancer detection rate between 18 and 57%, compared with current guidelines; however, the strategies did not uniformly require additional resources. Strategies involving HPV mRNA testing required fewer resources, whereas HPV DNA-based strategies detected >50% more precancers, but were more costly and required twice as many colposcopy referrals compared with the current guidelines. Strategies involving biomarkers to triage younger women with minor cervical cytological lesions have the potential to detect additional precancers, yet the optimal strategy depends on the resources available as well as decision-makers' and women's acceptance of additional screening procedures. Women with minor cervical lesions may be triaged more accurately and effectively using novel biomarkers.

Highlights

  • In Norway, cervical cancer (CC) remains the third most common cancer among women aged 25-49 years, who are in their productive social and working years [1]

  • Paper III indicate that in order to maximize the CC preventive benefits of the future primary human papillomavirus (HPV)-based screening program, while controlling colposcopy referral rates, HPV-based screening should start at an earlier age and rather utilize a less intensive triage algorithm for HPV-positive/cytology-negative women

  • In order for screening to remain costeffective for women who received the HPV vaccine in adolescence, Paper IV suggests that a de-intensified HPV-based screening strategy is required

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Summary

Introduction

In Norway, cervical cancer (CC) remains the third most common cancer among women aged 25-49 years, who are in their productive social and working years [1]. This is despite substantial reductions in CC incidence following more than two decades of organized cytology-based screening [2]. The introduction of HPV immunization programs is expected to reduce the risk of developing CC among vaccinated individuals, prompting decision-makers to consider the impact of HPV vaccination on optimal CC screening approaches. 2.1 HPV and cervical cancer 2.1.1 Human papillomavirus and related diseases HPV is a common sexually transmitted infection which may cause genital warts, recurrent respiratory papillomatosis, and occasionally, cancer [5]. Infection with HPV-6 and -11 low-risk types is associated with most genital warts and recurrent respiratory papillomatosis [7]

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