Clinical and Budget Impact of Primary HPV Genotyping for Cervical Cancer Screening in Peru

Abstract

Introduction: Cervical cancer is an important public health topic in Peru as it is the second leading cause of oncology-attributed mortality among women in the country. Conventional cytology was previously the standard method for cervical cancer screening, but recognized to have low test sensitivity in detecting pre-cancerous lesions. After a growing number of countries have implemented human papillomavirus (HPV) testing as part of a primary screening approach in order to reduce the incidence of cervical cancer, Peru did the same issuing the 2017 national guidelines. The objective of this study was to compare, from the Peruvian public payer perspective, the clinical and budget impact of conventional cytology versus HPV testing with genotyping or co-testing (cytology and HPV testing with genotyping) for primary cervical cancer screening. Methods: A decision analytic model was used to estimate the clinical and budget impact of each screening approach over a ten year period. A Markov model was used to simulate the natural history (progression and regression) of HPV and project the annual incidence of cervical cancer. The analysis was conducted on a hypothetical cohort of 4,000 women between 30 and 65 years eligible for cervical cancer screening. Epidemiological and clinical data were derived from the published literature and from the Addressing THE Need for Advanced HPV Diagnostics (ATHENA) trial. The analysis included cervical cancer screening, diagnosis, and treatment costs from the national Reimbursement Tariff Listing of the Seguro Integral de Salud (SIS), Peru in addition to Peruvian gynecologic oncologists opinion when SIS costs were not available. One-way sensitivity analysis was conducted on all model inputs to evaluate the impact of uncertainty on results. Results: In the base-case analysis, 58.6%, 83.7% and 90.5% of CIN2 and CIN3 pre-cancer lesions were detected among women by conventional cytology, HPV test with genotyping and co-testing (cytology and HPV test with genotyping) respectively. Relative to conventional cytology, introduction of HPV test with genotyping is estimated to reduce the annual incidence of cervical cancer from 3.3 per 100,000 to 2.7 per 100,000 with an incremental budget impact of 0.62 USD per screened woman per year. A co-testing approach was estimated to reduce the annual incidence to 2.5 per 100,000 with budget impact of 1.37 USD per screened woman per year. Conclusions: HPV primary screening with genotyping, either implemented alone or as part of a co-testing approach, improves early cervical cancer detection and reduces cervical cancer incidence and associated mortality with minimal budget impact on a per screened woman per year basis. Including HPV primary screening with genotyping for the screening of women aged 30 to 65 years may be a cost-beneficial approach to reduce cervical cancer incidence among women in Peru. Keywords: Cervical Cancer; Budget Impact; HPV Primary Screening; Peru Abbreviations: ATHENA: Addressing THE Need for Advanced HPV Diagnostics; SIS: Seguro Integral de Salud; HPV: Human Papillomavirus; CIN: Cervical Intraepithelial Neoplasia; USD: United States Dollars; ICC: Invasive Cervical Cancer; LSIL: low-grade squamous intraepithelial lesion; HSIL: high grade squamous intraepithelial lesion; ASC-US: Atypical Squamous Cells of Undetermined Significance