Italian Study to Assess the Best Cervical Cancer Screening Scheme for Vaccinated Women

Key Contextual Factors

• In Italy each Region has a partial autonomy concerning health policies.
• The National Vaccination Plan schedules HPV vaccination for girls in their 11th/12th year. The coverage is around 60% decreasing over time (1). Some Regions enlarged vaccination also for girls in their 16th year.
• In recent years, the cervical screening protocol has moved from Pap smear to HPV test as the primary test for women from the age of 30 till the age of 64 . For 25 to 29 years old women the primary test remains Pap smear.
• The Ministry of Health and the National Centre for Screening Monitoring (ONS) promoted actions to define the best cervical screening policies in the new situation.

Key Components/Steps

• A Health Technology Assessment (HTA) was carried out in order to evaluate the health, economic, organizational, social, legal and ethical impact of an updated screening program for HPV vaccinated women.
• A Consensus Conference (CC) involving several Scientific Societies and Stakeholders was held at the end of 2015 to define the best screening methods for girls vaccinated against HPV (2).
• Research projects, supported by Ministry of Health, were carried out to evaluate these topics. In three Regions, 25 years old women, invited to HPV vaccination in their 15th/16th were offered HPV test instead of Pap smear with a different assessment protocol in order to avoid over detection. In such a way the impact of vaccination was evaluated (3).

Main Impacts / Added Value

• The cervical screening is the first screening where a risk-stratified approach will be applied: in particular, a different screening protocol will be proposed according to vaccination status.
• The benefits of the new protocol consists in avoiding unnecessary tests, colposcopy and biopsies.
• The benefit for the society will be a more efficient use of resources. The savings could be used to promote active action to reach women neither vaccinated nor screened.
• At the moment the National Preventive Plan 2020-2025 indicates that girls vaccinated in their 11th/12th should start screening at the age of 30 with HPV test and that for vaccinated women the risk for cervical cancer decreases substantially. Regions are planning their Regional Plan on this issue.

Lessons Learned

The path in decision making concerning vaccination and screening result was exemplary:

• The monitoring system by means of screening to evaluate the impact of vaccination should become permanent.
• Tailored screening for individual vaccinated women would speed up the implementation of a program optimized for vaccinated women, compared to one-size-fits-all applied to the entire cohort targeted by vaccination campaign.
• Linkage between vaccination and screening archives is crucial. The different interpretation of privacy law could be a serious barrier.
• The vaccination (at least at 16 years) could determine an increase of inequality: in fact, a part of population will be completely protected (vaccinated and regularly screened) while another will be completely not protected (no screened and no vaccinated) Active actions should be implemented to overcome barriers taking into account in particularly not screened and not vaccinated woman, migrated woman.

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