Health utilities lost and risk factors associated with HPV-induceddiseases in men and women: The HPV Italian collaborative study group


Purpose: A complete economic evaluation requires accurate data concerningthe resources used, outcomes, and utilities (patient’s preferences)to properly value the cost utility of human papillomavirus (HPV)vaccination strategies. This study was designed to measure the utilityloss in health states affected by a broad range of HPV-induced pathologiesin both sexes in Italy. As a secondary objective, risk factors influencingthe viral transmission and development of HPV infections were alsoinvestigated. Methods: Patients with a diagnosis of several HPV-inducedpathologies including atypical squamous cells of undetermined significance(ASC-US), cervical intraepithelial neoplasia (CIN), cervical andanal-colorectal cancer, head and neck squamous cell carcinoma (HNSCC)and anogenital warts (AWs) were evaluated. Utilities, quality oflife, and risk factors were elicited using a standardized and computer-guidedadministration of time trade-off, European Quality of Life 5 Dimensions(EQ-5D), 3 levels, and risk factor questionnaires. Utilities weremeasured at 6 clinical research centers across Italy. A group ofhealthy subjects was used as a control. A mean number of 20 healthysubjects was used as a control for each pathology group. Findings:Overall, 600 respondents were eligible for analysis: 465 patients(mean [SD] age, 44.0 [16.3] years) and 135 controls (mean [SD] age,44.0 [13.2] years). With the exception of anal and HNSCC cancer,no statistically significant differences were observed between caseand control groups, in terms of either age or quality of life atthe time of interview. The patients' perception of their health conditionat baseline was equal to an EQ-5D score of 0.87 (0.22). The mean(SD) value of utilities associated with the HPV-induced pathologiescorresponded to 0.83 (0.24), 0.78 (0.27), 0.83 (0.22), 0.81 (0.27),0.58 (0.31), 0.51 (0.26), and 0.69 (0.30) for ASC-US, AWs, CIN 1(mild), CIN 2-3 (moderate to severe), cervical cancer, anal cancerand HNSCC, respectively. Utility lost due to AWs was significantlyhigher in females compared with males (0.71 [0.29] vs 0.83 [0.25];P: 0.018). Having >5 sexual partners increased the risk of acquiringHPV-induced infections as much as 2.52-fold (P: 0.004), whereasfor smoking or the age at start of sexual activity younger than 18years, the risk increased by $∼$ 1.62-fold (P: 0.034). High levelsof education were associated with a statistically significant protectiveeffect (P < 0.001). Implications: Risk factors and utilities elicitedin this study can be used as part of future economic assessmentsof other HPV vaccination strategies, including an immunization programfor preadolescents of both sexes in Italy.

Clinical Therapeutics
Gianluca Baio
Gianluca Baio
Professor of Statistics and Health Economics