The Health Technology Assessment of bivalent HPV vaccine Cervarix in Italy

INTRODUCTION: Health Technology Assessment (HTA) approach was applied to Human Papilloma Virus (HPV) vaccine in the Italian context. METHODS: Epidemiology and costs of HPV infection and related diseases, vaccine efficacy, clinical and economic impact of the HPV vaccination and women's knowledge and attitudes towards vaccination were assessed. RESULTS: HPV infections pooled prevalence in Italy was 19% (95%CI: 10-30%) and cervical cancer incidence was 9.8/100,000 per year. The mean costs for in situ and invasive carcinoma hospitalisation were estimated respectively in euro1745.87 and euro2616.16. HPV vaccines have demonstrated high efficacy and good safety profile. The meta-analysis on efficacy results in preventing persistent cervical infections by HPV16 and 18 for both HPV vaccines resulted in 87% (95%CI: 80-91%) and 78% (95%CI: 62-87%). Modelling the impact of vaccination with bivalent vaccine, it would reduce cancer cases by 67% and be cost-effective, with a cost per Quality Adjusted Life Years (QALYs) gained of euro22,055. CONCLUSION: The thoroughness of the evaluation allowed us accounting for all the aspects of HPV infection/diseases. The HTA report on the HPV vaccine demonstrated to be a comprehensive tool for an informed decision making proces