OBJECTIVES: Human Papilloma Virus (HPV) is responsible for both benign and malignant genital disease. The objective of this study was to review the available epidemiological and cost information for genital warts (GW), with a focus on the female population, the current target for HPV vaccination in Italy.  METHODS: The study analyzed scientific literature, data from the Italian Centres of Surveillance of Sexually Transmitted Infections (MST), the National Hospital Discharge and the National Drug Utilisation databases. National tariffs for ambulatory visits, hospitalizations and drugs costs were used to estimate the overall cost of GW disease for the Italian National Health System (NHS). The overall cost for prevention and treatment of cervical cancer was taken from La Torre 2007.RESULTS: No Italian specific publications were found regarding GW epidemiology; however from applying European incidence rates to the female Italian population, 30,000 new GW cases/year were estimated. According to MST data, there were 8,000 public clinic visits relating to female GWs (20,000 visits for male GWs), suggestive of a considerable use of private gynaecologists. In 2004 hospitalizations due to female GWs totalled 512 plus 1728 day-admissions. Including the cost of the specific medicines (approx. €2.4M/year for imiquimod), the overall cost to the Italian NHS was estimated as €4.3M per year for the diagnosis and treatment of female GWs (approx. 9.2M € for the whole population). Using data from Merito (ISPOR Dublin 2007) estimating the average cost for outpatient management of GWs as €147/case, the total expenditure for the management of the GWs in the Italian female population could be up to €7.1M.  CONCLUSIONS: The NHS expenditure for the management of GW in the Italian female population was estimated to represent 2.1-4.4% of the total expenditure for prevention and treatment of HPV-related cervical cancer disease.