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 €1745.87 and €2616.16. 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 €22,055. 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 process.