The Potential Clinical and Economic Value of a Human Papillomavirus Primary Screening Test that Additionally Identifies Genotypes 31, 45, 51, and 52 Individually.

BACKGROUND While current human papillomavirus (HPV) genotype screening tests identify genotypes 16 and 18 and do not specifically identify other high-risk types; a new extended genotyping test identifies additional individual (31, 45, 51, and 52) and groups (33/58, 35/39/68, and 56/59/66) of high-risk genotypes. METHODS We developed a Markov model of the HPV disease course and evaluated the clinical and economic value of HPV primary screening with Onclarity capable of extended genotyping in a cohort of women ≥30 years old. Women with certain genotypes were later rescreened instead of undergoing immediate colposcopy and varied which genotypes were rescreened, disease progression rate, and test cost. RESULTS Assuming 100% compliance with screening, HPV primary screening using current tests resulted in 25,194 invasive procedures and 48 invasive cervical cancer (ICC) cases per 100,000 women. Screening with extended genotyping (100% compliance) and later rescreening women with certain genotypes averted 903-3,163 invasive procedures and resulted in 0-3 more ICC cases compared to current HPV primary screening tests. Extended genotyping was cost-effective [$2,298-$7,236/quality-adjusted life year (QALY)] when costing $75 and cost saving (median: $0.3-$1.0 million) when costing $43. As the probabilities of disease progression increased (2-4 times), extended genotyping was not cost-effective as it resulted in more ICC cases and accrued fewer QALYs. CONCLUSIONS Our study identified the conditions under which extended genotyping was cost-effective and even cost saving compared to current tests. A key driver of cost-effectiveness is the risk of disease progression, which emphasizes the need to better understand such risks in different populations.