PMD95 - ECONOMIC EVALUATION OF STRATEGIES WITH/WITHOUT P16 FOR OPPORTUNISTIC CERVICAL CANCER SCREENING

Abstract

Currently, histological evaluation of cervical biopsy tissue for CIN lesion detection relies on subjective morphological appraisal of H&E stained tissue, which could lead to incorrect diagnoses or inconclusive results. The CINtec p16 Histology test provides objective biomarker data that assists pathologists in their assessment of cervical biopsies. The aim of this study was to access the impact of introducing CINtec p16 Histology into the diagnostic algorithm compared to a scenario with H&E alone as diagnostic method in the screening strategy of HPV 16/18 co-testing genotyping & cytology with reflex to CINtec PLUS, which could deliver the best effectiveness for the opportunistic cervical cancer screenings in urban hospitals as proven by previous research. A Markov cohort model was established to simulate cervical cancer screening in 100,000 volunteer women aged from 30 to 65. The costs and effectiveness of strategies with/without p16 were calculated from the perspective of China’s healthcare system. Over the 10 years (2 screening cycles), compared with H&E alone as diagnostic method, 17.2% more CIN2 and 3.8% more CIN3 were detected with the CINtec p16 Histology test at the increased annual cost of US$35,677(2.32%). Extending to 50 years, the total cost of adding the CINtec p16 Histology test to the diagnostic testing algorithm was 0.95% higher than the current practice. There were however quality of life gains, resulting in an incremental cost effectiveness ratio (ICER) of US$ 2,563 per QALY, which sat well within the WTP threshold of China’s GDP per capita in 2017. In general, compared with H&E alone, the use of CINtec p16 Histology in conjunction with H&E as diagnostic method was very cost effective, which was recommended to be included into the cervical cancer management methods.