• Clinical Preventive Service Recommendations
• The Value of Prevention
• Condition / Disease Specific Information
• Preventive Intervention Information
• Strength of Evidence

• Summary Plan Description
• CPT Codes

• Business Group Resource(s)
• CDC Resource

Evidence Statement

Clinical Preventive Service Recommendations for Screening

U.S. Preventive Services Task Force Recommendation

The U.S. Preventive Services Task Force (USPSTF) strongly recommends cervical cancer screening for all women who have been sexually active and have a cervix.¹

Evidence Rating: A (Strongly Recommended/ Good Evidence)
The USPSTF found good evidence that the benefits of screening for cervical cancer substantially outweigh the risks associated with screening.¹

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The Value of Prevention

Economic Burden of Condition/Disease

The direct medical care costs associated with cervical cancer were estimated to equal $1.7 billion in year 1996 dollars based on SEER (Surveillance, Epidemiology, and End Results) and Medicare-linked data.¹²

Workplace Burden of Condition/Disease

The cost of cervical cancer ($1.7 billion) would be significantly higher if work loss and premature deaths were included in the analysis. For example, 25.9 years of life are lost, on average, by each woman who dies of cervical cancer. These lost years of life—which often occur during the prime working years—translate into lost earnings for women and their families, worker-replacement costs for businesses, and are a significant cost to society.¹³

Economic Benefit of Preventive Intervention

As with most preventive services, screening for and treating cervical cancer in its early stages is much less expensive than intervening at later stages in the disease process. For example, the cost of treating a single case of localized (early-stage) cervical cancer averages $20,255, while the cost of treating a single case of distant (late-stage) disease averages $36,912 (both figures in year 2000 dollars).¹⁴ In addition to reduced medical care costs, the years of life gained from early detection and treatment are valuable to families, businesses, and the community at large.¹³

Estimated Cost of Preventive Intervention

The cost of a conventional Pap smear test will vary depending on location, type of provider, and the patient's age. In 2004, the private-sector cost of screening for cervical cancer among women under age 65 averaged $31 including specimen collection, laboratory processing, and interpretation; approximately 95% of all paid claims fell within the range of $9 to $64.¹⁵ For Medicare eligible women, cervical cancer screening cost an average of $28 and approximately 95% of all paid claims fell within the range of $0 to $62.¹⁵

Costs of vaccination are in addition to the costs for recommended screening services.

Estimated Cost of Treatment

The costs associated with an abnormal Pap test as a result of HPV infection, including the cost of physician visits, laboratory tests, colposcopies, and treatment of cervical neoplasia if present, were estimated to be $1,281 per patient in year 2000 dollars.¹⁴

The cost of treating established cervical cancer varies. Localized (early-stage) cervical cancer costs and average of $20,255 to treat and distant (late-stage) disease costs an average $36,912 to treat (both figures in year 2000 dollars).¹⁴

Cost-Effectiveness and/or Cost-Benefit Analysis of Preventive Intervention

The relative costs and benefits of screening will vary depending on the age of patients screened and the screening interval. A recent study (that included patient-time costs) estimated that the cost-effectiveness ratio of a conventional Pap test repeated every three years up to the age of 75 was $11,830 per quality-adjusted life year (QALY) saved (in year 2000 dollars).⁶ In comparison to other preventive interventions and to commonly accepted cost-effectiveness benchmarks, cervical cancer screening is highly cost-effective.¹⁶

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Condition / Disease Specific Information

Epidemiology of Condition/Disease

Cervical cancer was once the most common cause of cancer death among women in the United States, but the death rate from cervical cancer dropped 74% between 1955 and 1992, due to screening, earlier detection and treatment, and more effective treatment methods.² Despite this progress, cervical cancer remains a major cause of premature morbidity and mortality among women in the United States.

In 2011, it was estimated that 12,710women would be diagnosed with cervical cancer and 4,290women would die as a result of the disease. Cervical cancer is most common among women in their 40s to 60s, although some women develop cancer in their 30s.³

Cervical cancer screening has been conducted using the conventional Pap test screening method since 1940; the Pap test has proven to be one of the most successful methods of cancer prevention and early detection available.4 More than 50% of women who develop cervical cancer have never been screened for cervical cancer and 60% of women who develop cervical cancer have not been screened in the previous 5 years.^4,5 The dose-response relationship between the number of times a woman is screened during her lifetime and her likelihood of developing cervical cancer is illustrated in the following table:

Condition/Disease Risk Factors

The major risk factor for cervical cancer is infection with the human papillomavirus (HPV), a common sexually transmitted infection (STI). Clinical research shows that 95% to 100% of all squamous cell cervical cancers and 75% to 95% of all cervical intraepithelial neoplasia (CIN) lesions (a precursor to cervical cancer) can be linked to infection with HPV.⁶ HPV is the most common sexually transmitted disease in the United States; over 50% of adults contract an HPV infection during their lifetime.⁷ In most women infected with HPV, the virus remains asymptomatic and does not progress to precancerous lesions (CIN or dysplasia) or cervical cancer.8">8,9 However, approximately 5% to 10% of women with persistent HPV infection develop cervical cancer during their lifetimes if they do not have a Pap test to detect precancerous lesions and do not receive appropriate follow-up care.⁹

In 2006, the Food and Drug Administration (FDA) licensed a vaccine to reduce the risk of cervical cancer. The Advisory Committee on Immunization Practices (ACIP) recommends the use of this vaccine.¹⁰ The vaccine is not a substitute for recommended screening services: screening is still the primary method of cervical cancer prevention.¹⁰ Additional information on the HPV vaccine is provided in the Immunization Evidence-Statement.

Although cervical cancer precursor lesions only develop after HPV infection, other factors—such as age, being a smoker, starting sexual intercourse at an early age, having a large number of sexual partners, using oral contraceptives, and having seven or more live births—increase a woman's risk of cervical cancer.⁸ Some research suggests that diet; a woman's immune status and genetic predisposition; and co-infection with chlamydia, HIV/AIDS, or other sexually transmitted infections (STIs) may also influence risk of developing cervical cancer.^8,11

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Preventive Intervention Information

Preventive Intervention: Purpose of Screening

The purpose of screening for cervical cancer is twofold. First, screening reduces the risk of cervical cancer by identifying women with precancerous conditions that can be treated before the conditions progress to cancer. The primary precursor lesions of cervical cancer, CIN III and carcinoma in situ, progress slowly, often over more than 8 to 9 years. Pap test screening detects these lesions before they develop into invasive cancers and, with appropriate and timely treatment, a full recovery is likely. Second, screening can identify women with cervical cancer before symptoms appear. Early detection, which allows for early treatment, improves outcomes.¹

Benefits and Risks of Intervention

The benefits of cervical cancer screening are substantial. Screening reduces cervical cancer incidence and mortality. When Pap test screening programs are introduced into populations for the first time, the risk of developing cervical cancer is typically reduced by 60% to 90% within 3 years.¹¹ Mathematical models suggest that population-wide screening with the Pap test every 3 years reduces the rate of invasive cervical cancer by 91%; screening with the Pap test every 5 years reduces the rate by 84%.^5,11 In North America and Europe, the introduction of screening programs was associated with reductions in cervical cancer mortality of between 20% and 60%.¹¹

The harms of screening for cervical cancer are small compared to the benefits. False-positive screening results may lead to unnecessary treatment of low-grade lesions, unnecessary evaluations and biopsies, and psychological stress.¹¹

Screening is of little or no value among women who have undergone a hysterectomy for benign disease. The USPSTF suggests that clinicians obtain a full and accurate surgical history to confirm indication for hysterectomy and that a total hysterectomy has been performed before deciding against screening.¹¹

Initiation, Cessation, and Interval of Screening

The USPSTF recommends that screening begin within 3 years of the onset of sexual activity or the age of 21, whichever occurs first, and continue until the age of 65 for adult women of normal risk. Some professional organizations recommend more frequent Pap tests, but the USPSTF found no direct evidence that annual screening achieves better outcomes than screening every 3 years. Further, although screening women who are not sexually active has little value, many professional organizations recommend that clinicians screen all women over the age of 21 for cervical cancer because women may not always accurately report their history of sexual activity.¹¹

Because the risk of cervical cancer decreases after the age of 65 in women who have a history of normal Pap test results, the risks associated with screening, including false-positive results and inconvenience, outweigh the benefits of screening for older women.¹ Screening is recommended in older women who have not been previously screened, when information about previous screening is unavailable, or when screening is unlikely to have occurred in the past (e.g., among women from countries without screening programs).¹ Evidence is limited to define "adequate recent screening." The American Cancer Society (ACS) guidelines recommend that older women who have had three or more documented, consecutive, technically satisfactory normal/negative cervical cytology tests, and who have had no abnormal/positive cytology tests within the last 10 years, can safely stop screening.²

Note: In addition to screening, coverage should be provided for immunization with the HPV vaccine in accordance with recommendations by the Advisory Committee on Immunization Practices (ACIP). For more information on the HPV vaccine, please refer to the Immunization Evidence-Statement.

Intervention Process

The approved screening method for cervical cancer is the conventional Pap test. Newer screening methods, such as liquid-based, thin-layer preparations (e.g., ThinPrep®), computer-assisted screening (e.g., AutoCyte®), and human papillomavirus (HPV) tests, such as Hybrid Capture II®, are available. Purchasers may choose to cover these screening tests in addition to the conventional Pap test.⁴

Treatment Information

Health coverage should include provisions for diagnostic and treatment services.

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Strength of Evidence

The level of evidence supporting the recommendations contained in this chapter is described below.

Evidence-Based Research:
U.S. Preventive Service Task Force (USPSTF)
Strength of Evidence: A (Strongly Recommended/Good Evidence)

• The USPSTF found good evidence to recommend cervical cancer screening for all women who have been sexually active and have a cervix.³

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Summary Plan Description

Covered Screening

Conventional Pap test.

***Health plans have the discretion to provide coverage for newer screening methods, such as liquid-based, thin-layer preparations (e.g., ThinPrep®) or computer-assisted screening (e.g., AutoCyte®), and human papillomavirus (HPV) tests, such as Hybrid Capture II®.

Initiation, Cessation, and Interval

Cervical cancer screening is a covered benefit for women age 21 (or women of any age 3 years within the onset of sexual activity) through age 65. Coverage beyond the age of 65 is provided for women with known risk factors, recent abnormal pap smears, inadequate previous screening, or when information about previous screening is unavailable or when screening is unlikely to have occurred in the past.

Coverage allows Pap tests to be performed at least once every three years, but not more than once per calendar year.

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CPT Codes

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Other Information and Resources

Business Group Resource(s)

• Cervical Cancer
• Cancer

CDC Resource

• Cervical Cancer

Author(s)

Campbell KP, Coates RJ, Chattopadhyay S. Cervical cancer evidence-statement: screening. In: Campbell KP, Lanza A, Dixon R, Chattopadhyay S, Molinari N, Finch RA, editors. A Purchaser's Guide to Clinical Preventive Services: Moving Science into Coverage. Washington, DC: National Business Group on Health; 2006.

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References

1. U.S. Preventive Services Task Force. Screening for cervical cancer. Summary of recommendations / supporting documents. Guide to Clinical Preventive Services. Rockville, MD: Agency for Health Care Research and Quality; 2003.
2. American Cancer Society. Detailed guide: Cervical cancer: What are the key statistics for cervical cancer? Available at: http://www.cancer.org/Cancer/CervicalCancer/DetailedGuide/cervical-cancer-key-statistics. Accessed 23 July 2011.
3. Ries LAG, Eisner MP, Kosary CL, Hankey BF, Miller BA, Clegg L, Mariotto A, Feuer EJ, Edwards BK (eds). SEER cancer statistics review, 1975-2002. Bethesda, MD: National Cancer Institute; 2005. Available at: http://seer.cancer.gov/csr/1975_2002/. Accessed May 21, 2009.
4. Nuovo J. Melinkow J. Howell LP. New tests for cervical cancer screening. Am Fam Physician. 2001;64(5):780-786.
5. McMeekin SD, McGonigle KF, Vasilev SA. Cervical cancer prevention: toward cost-effective screening. MedGenMed. 1999;1(2):1-14.
6. Mandelblatt JS, Lawrence WF, Womack SM, Jacobson D, Bin YI, Yi-Ting H. et al. Benefits and costs of using HPV testing to screen for cervical cancer. JAMA. 2002; 287(18):2372-2381.
7. Centers for Disease Control and Prevention. Genital HPV Infection — Fact Sheet. 2009. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Available at: http://www.cdc.gov/std/HPV/STDFact-HPV.htm Accessed 23 July 2011.
8. National Cancer Institute. Cervical cancer prevention PDQ. Available at: http://www.cancer.gov/cancertopics/pdq/prevention/cervical/Patient/page2. Accessed May 21, 2009.
9. Alliance for Cervical Cancer Prevention. Cervical cancer prevention fact sheet. Seattle, WA: Program for the Appropriate use of Technology in Health; 2003.
10. Markowitz LE, Dunne EF, Saraiya M, Lawson HW, Chesson H, Unger ER; Centers for Disease Control and Prevention (CDC); Advisory Committee on Immunization Practices (ACIP). Quadrivalent Human Papillomavirus Vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2007 Mar 23;56(RR-2):1-24.
11. Berg AO, Atkins D. Screening for cervical cancer. Recommendations and rationale. Guide to Clinical Preventive Services. 2nd Ed. US Preventive Services Task Force. Rockville, MD: Agency for Health Care Research and Quality; 2004.
12. Brown ML, Riley GF, Schussler N, Etzioni RD. Estimating health care costs related to cancer treatment from SEER-Medicare data. Medical Care. 2002 Aug;40(8 Suppl):IV-104-17.
13. Brown ML, Lipscomb J, Snyder C. The burden of illness of cancer: economic cost and quality of life. Annu Rev Public Health. 2001;22:91-113.
14. Chesson HW, Blandford JM, Gift TL, Tao G, Irwin KL. The estimated direct medical cost of sexually transmitted diseases among American youth, 2000. Perspect Sex Reprod Health. 2004; 36(1):11-19.
15. Thomson Medstat. Marketscan. 2004.
16. Eichler H, Kong SX, Gerth WC, Mavros P, Jonsson B. Use of cost-effectiveness analysis in health-care resource allocation decision-making: how are cost-effectiveness threshold expected to emerge? Value Health. 2004; 7(5):518-528.