Abstract
BackgroundIn Italy HPV vaccination with the quadrivalent vaccine (Gardasil®) is offered actively and free of charge to girls aged 12 since 2007. A nine-valent vaccine (Gardasil 9®) received the European market authorization in 2015 to protect, with only 2 doses, against around 90% of all HPV positive cancers, over 80% of high-grade precancerous lesions and 90% of genital warts caused by HPV types 6/11.MethodsA dynamic transmission model simulating the natural history of HPV-infections was calibrated to the Italian setting and used to estimate costs and QALYs associated with vaccination strategies. The analyses compared two strategies with the nine-valent vaccine (cervical cancer screening and vaccination in girls only or vaccination in boys and girls) to four alternative strategies (cervical cancer screening and vaccination with quadrialent vaccine in girls only, in both boys and girls, with bivalent vaccine in girls and screening strategy only). The National Health Service perspective was considered.ConclusionThe switch to the nine-valent vaccine in Italy can further reduce the burden associated to cervical cancer and HPV-related diseases and is highly cost-effective.ResultsCompared to the current vaccination program with quadrivalent vaccine, the nine-valent vaccine in a programme including girls and boys shows further reductions of 17% in the incidence of cervical cancer, 35 and 14% in anal cancer for males and females, as well as over a million cases of genital warts avoided after 100 years. The new technology is associated with an ICER of 10,463€ per QALY gained in universal vaccination, decreasing to 4483€ when considering the vaccine switch for girls-only.
Highlights
In Italy Human papillomavirus (HPV) vaccination with the quadrivalent vaccine (Gardasil®) is offered actively and free of charge to girls aged 12 since 2007
Compared to the current vaccination program with quadrivalent vaccine, the nine-valent vaccine in a programme including girls and boys shows further reductions of 17% in the incidence of cervical cancer, 35 and 14% in anal cancer for males and females, as well as over a million cases of genital warts avoided after 100 years
The new technology is associated with an incremental costeffectiveness ratio (ICER) of 10,463€ per quality adjusted life year (QALY) gained in universal vaccination, decreasing to 4483€ when considering the vaccine switch for girls-only
Summary
In Italy HPV vaccination with the quadrivalent vaccine (Gardasil®) is offered actively and free of charge to girls aged 12 since 2007. HPV infection can persist and progress to cancer. The over 100 different HPV types identified have been divided into high and low risk types according to the risk for progression to cancer. Cervical cancer is the second most common cancer in young women in the European Union, and most cases are attributable to HPV infection, the primary cause being the persistent infection of the genital tract by high-risk types (HPV 16/18/33/45) [5,6,7]. The second category, low-risk HPV types, do not cause cancer but are the agents of skin and genital warts. Low-risk HPV types include types 6 and 11, that are responsible
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