Cost-Effectiveness of Primary HPV Testing, Cytology and Co-testing as Cervical Cancer Screening for Women Above Age 30 Years

Journal of General Internal Medicine, Jul 2016

Background Cervical cancer screening guidelines for women aged ≥30 years allow for co-testing or primary cytology testing. Our objective was to determine the test characteristics and costs associated with Cytology, HPV and Co-testing screening strategies. Main Methods Retrospective cohort study of women undergoing cervical cancer screening with both cytology and HPV (Hybrid Capture 2) testing from 2004 to 2010 in an integrated health system. The electronic health record was used to identify women aged ≥30 years who had co-testing. Unsatisfactory or unavailable test results and incorrectly ordered tests were excluded. The main outcome was biopsy-proven cervical intraepithelial neoplasia grade 3 or higher (CIN3+). Key Results The final cohort consisted of 99,549 women. Subjects were mostly white (78.4 %), married (70.7 %), never smokers (61.3 %) and with private insurance (86.1 %). Overall, 5121 (5.1 %) tested positive for HPV and 6115 (6.1 %) had cytology ≥ ASCUS; 1681 had both and underwent colposcopy and 310 (0.3 %) had CIN3+. Sensitivity for CIN3+ was 91.9 % for Primary Cytology, 99.4 % for Co-testing, and 94.8 % for Primary HPV; specificity was 97.3 % for Co-testing and Primary Cytology and 97.9 % for Primary HPV. Over a 3-year screening interval, Primary HPV detected more cases of CIN3+ and was less expensive than Primary Cytology. Co-testing detected 14 more cases of CIN3+ than Primary HPV, but required an additional 100,277 cytology tests and 566 colposcopies at an added cost of $2.38 million, or $170,096 per additional case detected. Conclusions Primary HPV was more effective and less expensive than Primary Cytology. Primary HPV screening appears to represent a cost-effective alternative to Co-testing.

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Cost-Effectiveness of Primary HPV Testing, Cytology and Co-testing as Cervical Cancer Screening for Women Above Age 30 Years

J Gen Intern Med Cost-Effectiveness of Primary HPV Testing, Cytology and Co-testing as Cervical Cancer Screening for Women Above Age 30 Years Xian Wen Jin 2 Laura Lipold 1 Julie Foucher Andrea Sikon 2 Jennifer Brainard 6 Jerome Belinson 5 Sarah Schramm Kelly Nottingham 3 4 Bo Hu 7 Michael B. Rothberg 2 4 0 Cleveland Clinic Lerner College of Medicine, Cleveland Clinic , Cleveland, OH , USA 1 Department of Family Medicine, Cleveland Clinic , Cleveland, OH , USA 2 Department of Internal Medicine, Cleveland Clinic , Cleveland, OH , USA 3 Heritage College of Osteopathic Medicine, Ohio University , Athens, OH , USA 4 Medicine Institute Center for Value Based Care Research, Cleveland Clinic , Cleveland, OH , USA 5 Department of Obstetrics and Gynecology, Cleveland Clinic , Cleveland, OH , USA 6 Department of Pathology, Cleveland Clinic , Cleveland, OH , USA 7 Department of Quantitative Health Science, Cleveland Clinic , Cleveland, OH , USA BACKGROUND: Cervical cancer screening guidelines for women aged ≥30 years allow for co-testing or primary cytology testing. Our objective was to determine the test characteristics and costs associated with Cytology, HPV and Co-testing screening strategies. MAIN METHODS: Retrospective cohort study of women undergoing cervical cancer screening with both cytology and HPV (Hybrid Capture 2) testing from 2004 to 2010 in an integrated health system. The electronic health record was used to identify women aged ≥30 years who had cotesting. Unsatisfactory or unavailable test results and incorrectly ordered tests were excluded. The main outcome was biopsy-proven cervical intraepithelial neoplasia grade 3 or higher (CIN3+). KEY RESULTS: The final cohort consisted of 99,549 women. Subjects were mostly white (78.4 %), married (70.7 %), never smokers (61.3 %) and with private insurance (86.1 %). Overall, 5121 (5.1 %) tested positive for HPV and 6115 (6.1 %) had cytology ≥ ASCUS; 1681 had both and underwent colposcopy and 310 (0.3 %) had CIN3+. Sensitivity for CIN3+ was 91.9 % for Primary Cytology, 99.4 % for Co-testing, and 94.8 % for Primary HPV; specificity was 97.3 % for Co-testing and Primary Cytology and 97.9 % for Primary HPV. Over a 3-year screening interval, Primary HPV detected more cases of CIN3+ and was less expensive than Primary Cytology. Co-testing detected 14 more cases of CIN3+ than Primary HPV, but required an additional 100,277 cytology tests and 566 colposcopies at an added cost of $2.38 million, or $170,096 per additional case detected. CONCLUSIONS: Primary HPV was more effective and less expensive than Primary Cytology. Primary HPV screening appears to represent a cost-effective alternative to Co-testing. INTRODUCTION Cervical cancer is the fourth leading cause of cancer death in women worldwide, with an estimated 275,000 deaths each year.1,2 Incidence of cervical cancer in the US has decreased >50 % because of the success of the Papanicolaou (Pap) test (cytology screening). As a result, cervical cancer mortality has also declined by half.3 The American Cancer Society estimates 4100 cervical cancer deaths in the US in 2015, most due to lack of screening or follow-up from abnormal testing.4 Elucidation of the role of high-risk human papillomavirus (HPV) in cervical cancer pathogenesis has led to incorporation of HPV testing into primary screening strategies for women age 30 and older.5 When cytology and HPV tests are used together (co-testing), sensitivity approaches 100 %,6 and the 5year risk of cervical intraepithelial neoplasia grade 3 or higher (CIN3+) after a negative co-test is far below that with negative cytology alone, supporting longer testing intervals.7,8 For this age group, multiple organizations now recommend co-testing every 5 years as an alternative to cytology.5,9–11 The American Cancer Society, The American Society of Colposcopy and Cervical Pathology (ASCCP) and the American Society of Clinical Pathology recommend co-testing as a Bpreferred^ screening strategy,5 although the appropriateness of this recommendation has been questioned.12 The US Preventive Service Task Force (USPSTF) recommends cytology or cotesting as acceptable screening. Co-testing is more expensive, but estimates of cost-effectiveness are lacking in the US.13 Several studies support the use of primary HPV testing (HPV followed by cytology for positive HPV results) due to its high sensitivity and negative predictive value.6,14–22 One systematic review suggests that co-testing has only marginal benefit over primary HPV testing, with significantly increased cost.23 In 2014, the Food and Drug Administration (FDA) approved the cobas® HPV Test (Roche Molecular Systems) for primary screening in women age 25 and older, and an interim guidance panel of the ASCCP and the Society of Gynecologic Oncology (SGO) stated that high-risk HPV testing could be considered an alternative to guidelinerecommended options.24 Despite FDA approval, a number of concerns remain. Some worry that primary HPV t (...truncated)


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Xian Wen Jin, Laura Lipold, Julie Foucher, Andrea Sikon, Jennifer Brainard, Jerome Belinson, Sarah Schramm, Kelly Nottingham, Bo Hu, Michael B. Rothberg. Cost-Effectiveness of Primary HPV Testing, Cytology and Co-testing as Cervical Cancer Screening for Women Above Age 30 Years, Journal of General Internal Medicine, 2016, pp. 1338-1344, Volume 31, Issue 11, DOI: 10.1007/s11606-016-3772-5