1. ecdc.europa.eu European Cervical Cancer Summit Meeting Brussels, 22 January 2008 Professor Johan Giesecke Chief Scientist, ECDC ECDC Guidance for the Introduction of HPV Vaccines in EU countries

2. Introduction ECDC is today publishing Guidance for the Introduction of HPV vaccines in EU countries. The purpose of the Guidance is to lay down the scientific basis to help the EU Member States make policy choices. The Guidance has been developed by panel of independent experts set up and coordinated by ECDC. Target audiences for the Guidance are: –national immunisation programme managers; –policy makers at EU-level and national level; –experts involved in advising on introduction of HPV vaccines.

3. What is ECDC ? A European Union Agency which : Is a member of the European Union (EU) family. Covers EU 27, EEA/EFTA countries and gradually integrating accession and candidate countries. Within neighbourhood policy and DG Relex, outreach to others countries beyond the EU 27. Supports and promotes global health security (role in International Health Regulations). Is financed by the EU budget. “An independent agency, named the European Centre for Disease Prevention and Control’” (Regulation 851/2004)

4. EU level disease surveillance Scientific opinions and studies Early Warning system and response Technical assistance and training Epidemic intelligence Communication to scientific community Communication to the public What is the role of ECDC? Identify, assess & communicate current & emerging health threats to human health from communicable diseases

5. ECDC works in partnership EU institutions: European Parliament, Commission, Council, EU agencies. WHO: HQ and EURO and other public health institutions. Member States: ECDC builds on networks, infrastructure and expertise of the Member States. ECDC has no institutions, research centres or laboratories of its own – “networks the networks” to ensure synergy and consistency between European and national levels.

6. Scientific Panel on HPV Chair, Prof Patricia Clayes University of Ghent, Belgium Dr Ahti Anttila Finnish Cancer Registry, Finland Prof Paolo Bonani University of Florence, Italy Prof Adam Finn Institut of Child Life and Health, UK Dr Daniel Lévy-Bruhl Institut de veille sanitaire, France Dr Kate Soldan Health Protection Agency, UK

7. Guidance outline The Guidance evaluates scientific evidence on: Cervical cancer and HPV infections in the EU The HPV vaccine HPV vaccines and cervical cancer screening programmes Target populations Strategy options for HPV vaccine delivery in EU countries Modelling costs and outcomes of HPV vaccination Monitoring and evaluation

8. Cervical cancer and HPV infections in the EU Cervical cancer is second most common cancer after breast cancer affecting women aged 15-44 in the EU. Each year there are around 33 000 cases of cervical cancer and 15 000 deaths in the EU. The primary cause of cervical cancer is persistent infection of the genital tract by high-risk HPV types.

9. The HPV Vaccine Two prophylactic HPV vaccines have been licensed in the EU. Both vaccines protect against the high-risk HPV types 16 and 18, responsible for an estimated 73% of cervical cancer cases in Europe. In large phase III trials both vaccines have been shown to prevent more than 90% of precancerous lesions associated with HPV types 16 and 18 among HPV-naïve women.

10. HPV vaccines and cervical cancer screening Well organised cervical cancer screening programmes are proven to reduce cervical cancer incidence by over 80%. HPV vaccine offers a complementary tool to improve the control of cervical cancer… …But does not eliminate need for cervical cancer screening even for vaccinated women. National authorities should continue efforts to organise and improve screening programmes independent of vaccine introduction.

11. HPV vaccines and cervical cancer screening (cont’d) HPV vaccines will have an impact on efficacy of existing screening programmes, which will need close monitoring. Women need to be informed and motivated to attend screening programmes, even if they are vaccinated. One of the most important challenges will be to achieve synergy between vaccination and screening in a cost-effective way with the maximum benefit for women.

12. Target populations The primary target group for routine vaccination should be young adolescent girls before they become sexually active. Targeting older girls and young women with catch-up vaccination could increase vaccination benefits in the short term. Country-specific factors are important to determine the exact age for routine vaccination, and the ages for any catch-up vaccination.

13. Strategy options for HPV vaccine delivery in EU countries School based immunisation is likely to be the lowest cost option for delivery of HPV vaccines to young adolescent girls. Clinic or practice-based immunisation is a universally available additional or alternative option for HPV vaccine delivery. Sexual and reproductive health and other medical clinics provided specifically for women may be important sites for immunisation, mainly for catch- up programmes.

14. Modelling costs and outcomes of HPV vaccination HPV vaccination should be evaluated not only for its efficacy, but also from an economic viewpoint. Economic evaluations are not entirely exportable, due to the variability of costs and healthcare systems in different countries. Efforts should be made by each country to perform such evaluation (taking into account the kind of cervical screening in place) before deciding on the best strategy to prevent cervical cancer. Studies undertaken in a number of countries indicate that HPV vaccination of young adolescent girls has a favourable cost-effectiveness profile.

15. Monitoring and evaluation Post-licensure evaluation of the HPV vaccines needs to determine: –Vaccine long-term efficacy and effectiveness; –Vaccination uptake and compliance; –Safety; –Integration of vaccination with other strategies such as organised screening. The minimum set of information to monitor HPV vaccination should include data on: vaccine coverage; adverse events; and sentinel surveillance of impact on pre-cancer lesions. Coordination between vaccine monitoring and cancer control programmes will be critical.

16. Final comments There are only five-year data available on the HPV vaccines and many questions still need to be answered. ECDC’s Guidance is made on the basis of current knowledge and will need to be re- evaluated in 6-12 months.

17. Thank you! www.ecdc.europa.eu | info@ecdc.europa.eu