The objectives of this study were to estimate the economic burden of human papillomavirus (HPV) in Italy, accounting for total direct medical costs associated with nine major HPV-related diseases, and to provide a measure of the burden attributable to HPV 6, 11, 16, 18, 31, 33, 45, 52, 58 infections.

A cost-of-illness incidence-based model was developed to estimate the incidences and costs of invasive cervical cancer, cervical dysplasia, cancer of the vulva, vagina, anus, penis, oropharyngeal, anogenital warts, and recurrent respiratory papillomatosis (RRP) in the context of the Italian National Health System (NHS). We used data from hospital discharge records (HDRs) of an Italian region and conducted a systematic literature review to estimate the lifetime cost per case, the number of incident cases, the prevalence of HPV9 types. Costs of therapeutic options not included in the diagnosis-related group (DRG) tariffs were estimated through a scenario analysis.

The total annual direct costs were EUR 540.7 million, with a range of EUR 338.3 – EUR 789.7 million. These costs could increase considering innovative therapies for cancers treatment (range EUR 16.2 – EUR 37.6 million). The fraction attributable to the HPV9 genotypes without innovative cancers treatment was EUR 329.2 million (range EUR 150.1 – EUR 576.7 million), accounting for sixty-one percent of the total annual burden of HPV-related diseases in Italy. Of this amount, EUR 136.7 million (forty-two percent) was related to men, accounting for sixty-four percent of the costs associated with non-cervical conditions.

The infections by HPV9 strains and the economic burden of non-cervical HPV-related diseases in men were found to be the main drivers of direct costs. The fraction of the total direct lifetime costs attributable to infections by HPV9 strains and the economic burden of non-cervical HPV-related diseases in men were found to be the main drivers of direct costs.