BACKGROUND: 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.

OBJECTIVES: 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.

METHODS: 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.

RESULTS: 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.

CONCLUSIONS: 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.