L’HTA come processo ciclico di valutazione e rivalutazione delle tecnologie sanitarie in Sanità Pubblica: il caso del vaccino bivalente anti-HPV nella nuova schedula a due dosi [Comunicazione orale]

[Autom. eng. transl.] The bivalent anti-HPV vaccine (Cervarix®) is authorized for the prevention of cervical cancer and precancerous genital lesions of the uterine cervix, vulva and vagina and is offered actively and free of charge to twelve year olds. During 2014, the European Medicines Agency (EMA) approved the two-dose vaccination schedule for adolescents between the ages of 9 and 14, replacing the three-dose one, used since 2007. In view of the Continuous updating of the health technology assessment processes and due to the modification of the vaccination schedule, a Health Technology Assessment (HTA) of the vaccination with Cervarix® was carried out, already the subject of a previous report published in 2007. Through the systematic review of the literature and the consultation of the current databases the following aspects have been addressed: state of implementation of anti-HPV vaccination and screening in Italy, new evidence to support vaccination efficacy and two-dose schedule, communication strategies. From the perspective of the National Health Service, a cost-utility assessment, with a lifetime time horizon, of the vaccination of the twelve-year cohort with Cervarix® in the two-dose schedule compared to non-vaccination and vaccination with the quadrivalent vaccine was also conducted. Finally, the values approach supported ethical evaluation. Anti-HPV vaccination has been implemented in all Italian regions since 2007 and the 2012-2014 Vaccination Prevention Plan has established, as a vaccination goal, coverage for the three doses ≥ 70% in the cohort of twelve-year-olds in 2001, ≥ 80% in the 2002 cohort and ≥ 95% starting from the 2003 cohort. Despite these objectives, the vaccination coverage in Italy is stable at around 69% with significant interregional differences. The data concerning the diffusion, the adhesion and the coverage of the screening show instead improvements over time, showing however regional differences. Moreover, several Italian regions have decided and are planning to move from cytology to HPV-DNA as a primary screening test for cervical cancer. The scientific literature on the effectiveness of HPV vaccines is rich in evidence from clinical trials and meta-analyzes. In particular, with reference to the latter, it is possible to establish that the efficacy of both HPV vaccines is greater than 90% for the prevention of CIN2 +. However, compared to cross-protection against non-vaccine genotypes, responsible for about 30% of cervical lesions, the bivalent vaccine appears to have superior characteristics, especially with reference to genotypes 31, 33 and 45. Data availability Finally, post-marketing surveillance allows confirmation of the safety of anti-HPV vaccines whose adverse reactions occur in approximately one in every 1,000 doses administered. The EMA approved the two-dose Cervarix® vaccination schedule based on non-inferiority, demonstrated in randomized controlled trials compared to the three-dose schedule. In the 9-14 age group, the two-dose vaccination schedule thus represents, to date, the only recommended one, contrary to what happens with the quadrivalent vaccine, also authorized in the two-dose schedule on the basis of a single evidence which showed the need for a follow-up for the evaluation of antibody persistence. Economic analysis has shown that Cervarix® is cost-effective when compared with non-vaccination. The cost-effectiveness ratio is also good in comparison with the quadrivalent vaccine. From an ethical point of view, Cervarix® is characterized by a favorable relationship between risks and benefits and meets the criteria of a fair allocation