Retest in 12mo with HPV testing BUDGET IMPACT MODEL FOR CERVICAL CANCER SCREENING USING HPV TESTS IN CHILE Franco Figueira S1, Cachoeira CV1, Souza FH1, Kano BY1, Silva M.2 , Poulios, N. 3 1Roche Diagnostics LATAM, 2Roche Diagnostics Chile, 3Roche Molecular, USA BACKGROUND RESULTS According to World Health Organization (WHO) data there are nearly 530,000 new cases of cervical cancer each year, making it the second most common cancer among women worldwide1. There is a clear correlation between human papillomavirus (HPV) and cervical cancer. Several strains of HPV are considered to be high-risk, namely 16,18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. However, almost 70% of all cervical cancers are caused by the 16 and 18 HPV genotypes4. The Budget Impact Model indicates that, when comparing the Strategy 2 and 3 to Strategy 1 there is an increase of ≥CIN2 (Cervical Intraepithelial Neoplasia) cases detected and treated, and a reduction at the number of patients progressing to cervical cancer. When comparing the strategy 2 to strategy 1, the model estimated annual savings of 1.9%, including screening, diagnosis and treatment (Table 1). There is also a decrease of 25% and 33% at the incidence of Cervical Cancer and Mortality Rate, respectively (Figure 2). Cytology alone Pooled HPV Total Annual Cost $18.758.150 $ 18.395.442 Total budget impact (362.708) % difference -1.9% OBJECTIVES The aim of this study is to estimate the clinical and budget impact of cervical cancer primary screening with a HPV16/18 genotyping test which simultaneously detects 12 other high risk HPV types, in the Chilean population. Table 1 Cervical cancer Annual costs of screening, diagnosis and treatment – Strategy 1 and 2 Better clinical results could be achieved when the strategy 3 is implemented. An additional investment of only 0.37% at the annual budget would be necessary to decrease the incidence of Cervical Cancer by 43% (Table 2) and the mortality rate by 54% in Chile (Figure 2). METHODS Based on ATHENA trial, a decision tree framework was used to model the screening and diagnosis of cervical cancer to compare three strategies from a payer’s perspective : (1) Cytology alone –Screening Interval (SI): 3 years; (2) Pooled HPV with reflex cytology as primary screening – SI: 5 years; (3) HPV with 16/18 genotyping and reflex cytology (cobas® 4800) as primary screening – SI: 5 years, Cytology alone HPV 16/18 test Total Annual Cost $18.758.150 $ 18.828.938 Total budget impact 70.788 % difference 0.37% Table 2 Cervical cancer Annual costs of screening, diagnosis and treatment – Strategy 1 and 3 Cobas® Test Negative or HPV- Routine Screening HrHPV Panel positive HPV 16/18 + HPV12 Panel + and 16/18 - Retest in 12mo with HPV testing Colposcopy/ Biopsy hrHPV Panel- hrHPV Panel+ Cytology Normal ASCUS/LSIL/HSIL/AGC Abnormal Figure 2 Clinical impact of the 3 strategies on Annual Cervical Cancer Incidence and Mortality rates CONCLUSION Figure 1 Decision tree framework for HPV with 16/18 genotyping test This analysis suggests that, compared to the current screening program in Chile, the use of Cobas® HPV genotyping test (strategy 3) is a potential effective management strategy, given that the clinical impacts are highly positives and budgetary impact could be basically neutral. The impact model was run by having women ≥30 and ≤ 64 years old progressing through the model with 2 screening cycles. In addition, screening, diagnosis and cancer treatment costs were calculated from FONASA public data (Fondo Nacional de Salud) reported in 2014 converted to 2015 US dollars (USD). References: 1- Human papillomavirus and related cancers: world. World Health Organization. 2- Wright Jr TC, Stoler MH, Sharma A, Zhang G, Behrens C, Wright TL, and the ATHENA Study Group. Evaluation of HPV-16 and HPV-18 genotyping for the triage of women with high-risk HPV+ cytology-negative results. Am J Clin Pathol, 2011; 136: 578-586 3- Castle PE, Glass AG, Rush BB, Scott DR, Wentzensen N, Gage JC, Buchland J, Rydzak G, Lorincz AT, Wacholder S. Clinical human papillomavirus detection forecasts cervical cancer risk in women over 18 years of follow-up. J Clin Oncol, 2012; 30(25): 3044-3050 4- Herzog TJ, Monk BJ. Reducing the burden of glandular carcinomas of the uterine cervix. Am J Obstet Gynecol 2007; 197: 566-571 Acknowledgments: This study was financially supported by Roche Diagnostics Latin America ISPOR 5th Latin America Conference 6-8 September 2015 Santiago, Chile Poster: PMD4