Asti Lindsey, Hopley Colin, Avelis Cameron, Bartsch Sarah M, Mueller Leslie E, Domino Molly, Cox Sarah N, Andrews Jeffrey C, Randall Samuel L, Stokes-Cawley Owen J, Asjes Caitlin, Lee Bruce Y
From the Public Health Computational and Operations Research (PHICOR), City University of New York (CUNY) School of Public Health and Health Policy, New York City, NY.
Health Economics and Outcomes Research, BD Diagnostics, Franklin Lakes, NJ.
Sex Transm Dis. 2021 May 1;48(5):370-380. doi: 10.1097/OLQ.0000000000001327.
Although 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.
We developed a Markov model of the HPV disease course and evaluated the clinical and economic value of HPV primary screening with Onclarity (BD Diagnostics, Franklin Lakes, NJ) capable of extended genotyping in a cohort of women 30 years or older. Women with certain genotypes were later rescreened instead of undergoing immediate colposcopy and varied which genotypes were rescreened, disease progression rate, and test cost.
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 to 3163 invasive procedures and resulted in 0 to 3 more ICC cases compared with current HPV primary screening tests. Extended genotyping was cost-effective ($2298-$7236/quality-adjusted life year) when costing $75 and cost saving (median, $0.3-$1.0 million) when costing $43. When the probabilities of disease progression increased (2-4 times), extended genotyping was not cost-effective because it resulted in more ICC cases and accrued fewer quality-adjusted life years.
Our study identified the conditions under which extended genotyping was cost-effective and even cost saving compared with 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.
尽管目前的人乳头瘤病毒（HPV）基因分型筛查检测能够识别16型和18型HPV，但无法特异性识别其他高危型别，而一种新的扩展基因分型检测能够识别更多的高危型别个体（31、45、51和52型）以及高危型别组（33/58、35/39/68和56/59/66型）。
我们建立了一个HPV疾病进程的马尔可夫模型，并在30岁及以上的女性队列中评估了使用Onclarity（BD诊断公司，新泽西州富兰克林湖）进行HPV初筛的临床和经济价值，该检测能够进行扩展基因分型。某些基因型的女性随后接受重新筛查，而非立即进行阴道镜检查，并且重新筛查的基因型、疾病进展率和检测成本有所不同。
假设筛查的依从性为100%，使用现有检测进行HPV初筛，每10万名女性中有25194例侵入性操作和48例浸润性宫颈癌（ICC）病例。与目前的HPV初筛检测相比，采用扩展基因分型进行筛查（依从性为100%）并随后对某些基因型的女性进行重新筛查，可避免903至3163例侵入性操作，且ICC病例增加0至3例。当成本为75美元时，扩展基因分型具有成本效益（每质量调整生命年2298 - 7236美元），当成本为43美元时可节省成本（中位数为30万至100万美元）。当疾病进展概率增加（2至4倍）时，扩展基因分型不具有成本效益，因为它会导致更多的ICC病例，且获得的质量调整生命年更少。
我们的研究确定了与现有检测相比，扩展基因分型具有成本效益甚至节省成本的条件。成本效益的一个关键驱动因素是疾病进展风险，这强调了更好地了解不同人群中此类风险的必要性。
