Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Department of Obstetrics and Gynecology, Faculty of Medicine, Srinakharinwirot University, Nakhonnayok, Thailand.
J Gynecol Oncol. 2019 Mar;30(2):e17. doi: 10.3802/jgo.2019.30.e17. Epub 2018 Nov 8.
To assess the clinical and cost-effectiveness of human papillomavirus (HPV) primary screening triage with p16/Ki-67 dual stain cytology compared to cytology.
We conducted an Excel®-based budget impact model to estimate the preinvasive and invasive cervical cancer cases identified, mortality rate, direct medical costs, quality-adjusted life years (QALYs) and the incremental cost-effectiveness analysis of two strategies from the healthcare payer perspective. The study population is a cohort of women 30-65 years of age presenting for cervical screening.
HPV primary screening triage with p16/Ki-67 dual stain showed higher sensitivity without losing specificity compared to conventional Pap smear. The improving the screening performance leads to decrease the prevalence of precancerous lesion, annual incidence and mortality of cervical cancer. The incidence of cervical cancer case detected by new algorithm compared with conventional method were 31,607 and 38,927, respectively. In addition, the new algorithm was more effective and more costly (average QALY 24.03, annual cost $13,262,693) than conventional cytology (average QALY 23.98, annual cost $7,713,251). The incremental cost-effective ratio (ICER) per QALY gained was $1,395. The sensitivity analysis showed if the cost of cytology and HPV test increased three times, the ICER would fall to $303/QALY gained and increased to $4,970/QALY gained, respectively.
Our model results suggest that screening by use of HPV genotyping test as a primary screening test combined with dual stain cytology as the triage of HPV positive women in Thai population 30-65 years old is expected to be more cost-effective than conventional Pap cytology.
评估人乳头瘤病毒（HPV）初筛中 p16/Ki-67 双染细胞学在细胞学中的临床和成本效益。
我们采用 Excel 预算影响模型，从医疗保健支付者的角度估计两种策略的宫颈癌前病变和浸润性癌病例数、死亡率、直接医疗成本、质量调整生命年（QALY）和增量成本效益分析。研究人群为 30-65 岁的宫颈筛查女性队列。
HPV 初筛联合 p16/Ki-67 双染细胞学较传统巴氏涂片具有更高的敏感性而不损失特异性。筛查性能的提高可降低癌前病变的患病率、宫颈癌的年发病率和死亡率。新算法与传统方法检测到的宫颈癌病例数分别为 31607 例和 38927 例。此外，新算法比传统细胞学更有效且成本更高（平均 QALY 24.03，年度成本 13262693 美元；平均 QALY 23.98，年度成本 7713251 美元）。每获得一个 QALY 的增量成本效益比（ICER）为 1395 美元。敏感性分析显示，如果细胞学和 HPV 检测成本增加三倍，ICER 将降至 303 美元/QALY，分别增加到 4970 美元/QALY。
我们的模型结果表明，在泰国 30-65 岁人群中，使用 HPV 基因分型检测作为初筛试验，结合 HPV 阳性女性的双染细胞学作为分流试验，预计比传统巴氏细胞学更具成本效益。
