Abstract

BackgroundHuman papillomavirus (HPV) is the leading cause of cervical cancer and other malignant and benign neoplastic lesions. HPV vaccination has three potential goals: to prevent transmission, infection, and disease. At present, there are no available data about health consequences of HPV immunization in Italy. The aim of this study is to evaluate the effect of current HPV vaccination strategy in Italy.MethodsA multistate morbidity-mortality model was developed to estimate the infection process in a theoretical cohort of Italian women. The Markov process considered nine health states (health, anogenital warts, grade 1 and grade 2/3 cervical intraepithelial neoplasia, cervical cancer, anal cancer, death due to cervical cancer, anal cancer and other causes), and 26 transition probabilities for each age group. The model was informed with the available data in national and international literature. Effectiveness of immunization was assumed considering a literature review pertaining to models and vaccination coverage rates observed in Italy. Life expectancy (ex), Quality-Adjusted Life Years (QALYs), Disability-Adjusted Life Years (DALYs), and attributable risk (AR) were estimated for no intervention (cervical cancer screening) and vaccination strategies scenarios.ResultsThe model showed that in a cohort of 100,000 Italian women the e0 is equal to 83.1 years. With current HPV vaccination strategy the e0 achieves 83.2 (+0.1) years. When HPV-related diseases are considered altogether, the QALYs increase from 82.7 to 82.9 (+0.2 QALYs) with no intervention and vaccination strategies respectively. DALYs decrease by 0.6 due to vaccination. Finally, AR is equal to 93 and 265 cases per 100,000 women in population and not vaccinated, respectively.ConclusionWhen mortality due to cervical cancer is considered, HPV vaccination seems to have a low impact on health unit gains in the Italian female population. Conversely, when several HPV-related and cancer morbidity conditions are included, the effect of vaccination becomes quite remarkable.

Highlights

  • Human papillomavirus (HPV) is the leading cause of cervical cancer and other malignant and benign neoplastic lesions

  • The objective of this study is to estimate the impact of HPV-related diseases on the Italian population, in terms of health conditions and death risk

  • The Markov process took into consideration nine health states, in addition to 26 transition probabilities

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Summary

Introduction

Human papillomavirus (HPV) is the leading cause of cervical cancer and other malignant and benign neoplastic lesions. HPV is involved both in the etiopathogenesis of invasive cervical cancer and in other malignant and benign neoplastic lesions that affect the vulva, vagina, anus, penis, head and neck, respiratory tract [recurrent respiratory papillomatosis (RRP)], and external anogenital area (genital warts acuminate) [2, 5,6,7,8,9]. HPV triggers about 600,000 cases of cervical cancer annually, cancer of the vulva, vagina, anus, penis, head and neck, as well as non-malignant neoplastic diseases, such as anogenital warts and recurrent respiratory papillomatosis (RRP), with an impressive medical and economic burden [10]. Italian data suggest the total direct cost associated with the annual incident cases of the nine HPV-related conditions (invasive cervical cancer, cervical dysplasia, cancer of the vulva, vagina, anus, penis, and head and neck, anogenital warts, and RRP) is estimated to be €528.6 million, with a plausible range of €480–686 million [11, 12]

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