CERVICAL CANCER (Screening)

Evidence Statement Benefit Plan Language Other Information and Resources Author(s)

References


Updated 10/01/12

Evidence Statement

Clinical Preventive Service Recommendations for Screening

This recommendation statement applies to women who have a cervix, regardless of sexual history. This recommendation statement does not apply to women who have received a diagnosis of a high-grade precancerous cervical lesion or cervical cancer, women with in-utero exposure to diethylstilbestrol, or women who are immunocompromised (such as those who are HIV positive).1

U.S. Preventive Services Task Force Recommendation

The USPSTF recommends screening for cervical cancer in women age 21 to 65 years with cytology (Pap smear) every 3 years or, for women age 30 to 65 years who want to lengthen the screening interval, screening with a combination of cytology and human papillomavirus (HPV) testing every 5 years.1

Evidence Rating: A (Strongly Recommended/ Good Evidence)
The USPSTF concludes that for women age 21 to 65 years, there is high certainty that the benefits of screening with cytology every 3 years substantially outweigh the harms. For women age 30 to 65 years, there is high certainty that the benefits of screening with a combination of cytology and HPV testing (co-testing) every 5 years outweigh the harms.1

  • The USPSTF recommends against screening for cervical cancer in women younger than age 21 years (D recommendation).
  • The USPSTF recommends against screening forcervical cancer in women older than age 65 years who have had adequate prior screening and are not otherwise at high risk for cervical cancer. See the Clinical Considerations for discussion of adequacy of prior screening and risk factors (D recommendation).
  • The USPSTF recommends against screening for cervical cancer in women who have had a hysterectomy with removal of the cervix and who do not have a history of a high-grade precancerous lesion (cervical intraepithelial neoplasia [CIN] grade 2 or 3) or cervical cancer (D recommendation).
  • The USPSTF recommends against screening for cervical cancer with HPV testing, alone or in combination with cytology, in women younger than age 30 years (D recommendation).

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The Value of Prevention

Economic Burden of Condition/Disease

The annual direct medical cost of cervical cancer prevention and treatment in the U.S. prior to introduction of the HPV vaccine was estimated at $6 billion.2 The current annual $1.7 billion cost of cervical cancer would be significantly higher if work loss and premature deaths were included in the analysis.3

Workplace Burden of Condition/Disease

On average, 26.3 years of life are lostby each woman who dies of cervical cancer.3 Most cervical cancer cases occur between the ages of 20 and 50 years.4 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.5

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. The Pap smearhas proven to be one of the most successful methods of cancer prevention and early detection available.6 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.5

Estimated Cost of Preventive Intervention

The cost of a conventional Pap smear will vary depending on location, type of provider, and the patient's age. In 2009, the private-sector cost of screening for cervical cancer among women aged 11-65 years averaged $31 including specimen collection, laboratory processing, and interpretation.7 Approximately 95% of all paid claims fell within the range of $13 to $66.15.7 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 $62.15.7

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

Estimated Cost of Treatment

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) cervical cancer averages $36,912 (both figures in year 2000 dollars).8

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

In comparison to other preventive interventions and to commonly accepted cost-effectiveness benchmarks, cervical cancer screening is highly cost-effective.9 Introduction of screening to populations previously unexposed to screening reduces cervical cancer rates by 60% to 90% within 3 years of implementation.10 The relative costs and benefits of screening will vary depending on the age of patients screened and the screening interval. A study that included patient-time costs estimated that the cost-effectiveness ratio of a conventional Pap smear repeated every three years up to the age of 75 was $11,830 per quality-adjusted life year saved (in year 2000 dollars).11

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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. However, between 1955 and 1992, the death rate from cervical cancer dropped 70% due to screening, earlier detection and treatment, and more effective treatment methods.4 Despite this progress, cervical cancer remains a major cause of premature morbidity and mortality among women in the U.S.

In 2011, it was estimated that 12,710women would be diagnosed with cervical cancer and 4,290 women would die as a result of the disease.6 Cervical cancer tends to occur in midlife; most cases are found in women younger than 50, and older than 20.4 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.6

Condition/Disease Risk Factors

It is well established that HPV infection is associated with nearly all cases of cervical cancer.1 HPV is the most common sexually transmitted disease in the United States; over 50% of adults contract an HPV infection during their lifetime.12 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.11 Other factors that put a woman at increased risk for cervical cancer include HIV infection; a compromised immune system; in utero exposure to diethylstilbestrol (a drug once prescribed during pregnancy to prevent miscarriages or premature deliveries which has been linked to vaginal cancer); and previous treatment of a high-grade precancerous lesion or cervical cancer.1,13

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 routine vaccination of females aged 11 or 12 years with three doses of either HPV2 or HPV4 for prevention of cervical cancers and precancers.14 Both vaccines might provide protection against some other HPV-related cancers in addition to cervical cancer, although there are currently only data sufficient to recommend HPV4 for protection against vulvar and vaginal cancers and precancers.14 The vaccination series can be started beginning at age 9 years. Vaccination is recommended for females aged 13 through 26 years who have not been vaccinated previously or who have not completed the three-dose series.14 The vaccine is not a substitute for recommended screening services; screening is still the primary method of cervical cancer prevention.14

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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.15 The primary precursor lesions of cervical cancer, CIN III and carcinoma in situ, progress slowly, often over more than 8 to 9 years.15 Pap smear 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.15 Early detection allows for early treatment, which improves outcomes.

Benefits and Risks of Intervention

The benefits of cervical cancer screening are substantial. Screening reduces cervical cancer incidence and mortality. When Pap smear 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.10 Mathematical models suggest that population-wide screening with the Pap smear every 2 years reduces the lifetime incidence of cervical cancer of between 70%?80%.11 In North America and Europe, the introduction of screening programs was associated with reductions in cervical cancer mortality of between 20% and 60%.15

Screening with cervical cytology or HPV testing can lead to harms. Abnormal test results can lead to more frequent testing and invasive diagnostic procedures, such as colposcopy and cervical biopsy.1 Harms from these diagnostic procedures include vaginal bleeding, pain, infection, and failure to diagnose (due to inadequate sampling).1 Abnormal screening test results are also associated with mild psychological harms; short-term increases in anxiety, distress, and concern about health have been reported with cytology and HPV testing.1

Initiation, Cessation, and Interval of Screening

The USPSTF recommends screening for cervical cancer in women age 21 to 65 years with cytology (Pap smear) every 3 years or, for women age 30 to 65 years who want to lengthen the screening interval, screening with a combination of cytology and human papillomavirus (HPV) testing every 5 years.1 Screening women age 21 to 65 years every 3 years with cytology provides a reasonable balance between benefits and harms.1 Among women age 30 to 65 years, HPV testing combined with cytology (co-testing) every 5 years offers a comparable balance of benefits and harms and is therefore a reasonable alternative for women in this age group who would prefer to extend the screening interval.1 Screening with cytology more often than every 3 years confers little additional benefit, with large increases in harms.

Intervention Process

The approved screening method for cervical cancer is the conventional Pap smear. 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.16 Evidence suggests that there are no clinically meaningful differences in accuracy between liquid-based cytology and conventional cytology.1 Purchasers may choose to cover these screening tests in addition to the conventional Pap smear.16

Treatment Information

Screening aims to identify high-grade precancerous cervical lesions to prevent development of cervical cancer and early-stage asymptomatic invasive cervical cancer.1 High-grade lesions may be treated with ablative and excisional therapies, including cryotherapy, laser ablation, loop excision, and cold-knife conization.1 Early-stage cervical cancer may be treated with surgery (hysterectomy) or chemoradiation.1 The treatment of precancerous rather than early-stage cancerous lesions is unique to cervical cancer and is the foundation of the success of cervical cancer screening.1 Treatment of precancerous lesions is less invasive than treatment of cancer and results in fewer adverse effects.1

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Strength of Evidence

Evidence-Based Research: U.S. Preventive Service Task Force (USPSTF)

Strength of Evidence: A (Strongly Recommended/Good Evidence)

The USPSTF concludes that for women age 21 to 65 years, there is high certainty that the benefits of screening with cytology every 3 years substantially outweigh the harms.1 For women age 30 to 65 years, there is high certainty that the benefits of screening with a combination of cytology and HPV testing (co-testing) every 5 years outweigh the harms.1

The ACS, ASCCP, and ASCP recently published screening guidelines that are very similar to the USPSTF's recommendations.17 The ACS/ASCCP/ASCP recommend that women age 21 to 29 years be screened with cytology (cervical cytology testing or Pap testing) alone every 3 years. Women age 30 to 65 years should be screened with cytology and HPV testing (co-testing) every 5 years or cytology alone every 3 years.1 The guidelines further state that no woman should be screened every year and that women age 21 to 29 years should not be screened with HPV testing or combined cytology and HPV testing.1

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Summary Plan Description

Covered Screening

Conventional Papanicolaou (Pap) smear 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 HPVtests, such as Hybrid Capture IIĀ®. Evidence from good- and fair-quality observational studies indicates that HPV testing generally has a higher sensitivity but lower specificity (that is, more false-positive test results) than does cytology in the detection of CIN2+ and CIN3+.1

Health coverage should include provisions for diagnostic and treatment services. 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).

Initiation, Cessation, and Interval

Cervical cancer screening is a covered benefit for women age 21 to 65 years. Coverage before the age of 21 or 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 smears to be performed at least once every three years, but not more than once per calendar year unless other risk factors are present.

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CPT Codes

Cervical Cancer (Screening)
88141 Cytopathology, cervical or vaginal, requiring interpretation by physician
88142 Cytopathology, cervical or vaginal, automated thin layer prep, manual screening under physician supervision
88143 Cytopathology, cervical or vaginal, automated thin layer prep, manual screening and rescreening under physician supervision
88147 Cytopathology smears, cervical or vaginal, screening by automated system, under physician supervision
88148 Cytopathology smears, cervical or vaginal, screening by automated system with manual rescreening under physician supervision
88150 Cytopathology slides, cervical or vaginal, manual screening under physician supervision
88152 Cytopathology slides, cervical or vaginal, manual screening and computer-assisted rescreening under physician supervision
88153 Cytopathology slides, cervical or vaginal, manual screening and rescreening under physician supervision
88154 Cytopathology slides, cervical or vaginal, manual screening and computer-assisted rescreening using cell selection and review under physician supervision
88155 Cytopathology slides, cervical or vaginal, definitive hormonal evaluation
88164 Cytopathology slides, cervical or vaginal (Bethesda), manual screening under physician supervision
88165 Cytopathology slides, cervical or vaginal (Bethesda), manual screening and rescreening under physician supervision
88166 Cytopathology slides, cervical or vaginal (Bethesda), manual screening and computer-assisted rescreening under physician supervision
88167 Cytopathology slides, cervical or vaginal (Bethesda), manual screening and computer-assisted rescreening using cell selection and review under physician supervision
88174 Cytopathology, cervical or vaginal, collected in preservation fluid, automated thin layer prep, screening by automated system under physician supervision
88175 Cytopathology, cervical or vaginal, collected in preservation fluid, automated thin layer prep, screening by automated system and manual rescreening or review under physician supervision
3015F Cervical cancer screening results documented and reviewed
S0610 Annual gynecological examination, new patient
S0612 Annual gynecological examination, established patient

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Other Information and Resources




Author(s)

Berryman P, Campbell KP, Coates RJ, Chattopadhyay S.A Purchaser's Guide to Clinical Preventive Services: Moving Science into Coverage. Washington, DC: National Business Group on Health; 2012.

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References

  1. U.S. Preventive Services Task Force. Screening for Cervical Cancer: U.S. Preventive Services Task Force Recommendation Statement. AHRQ Publication No. 11-05156-EF-2, March 2012. http://www.uspreventiveservicestaskforce.org/uspstf11/cervcancer/cervcancerrs.htm. Accessed March 27, 2012.

  2. Armstrong EP. Prophylaxis of Cervical Cancer and Related Cervical Disease: A Review of the Cost-Effectiveness of Vaccination Against Oncogenic HPV Types. April 2010. Journal of Managed Care Pharmacy 16 (3): 217?230.

  3. Howlader N et al. SEER Cancer Statistics Review, 1975-2008, National Cancer Institute. Bethesda, MD. http://seer.cancer.gov/csr/1975_2008/, based on November 2010 SEER data submission, posted to the SEER web site, 2011. http://seer.cancer.gov/csr/1975_2004/results_merged/topic_year_lost.pdf. Accessed February 23, 2012.

  4. American Cancer Society. Detailed guide: Cervical cancer: What are the key statistics for cervical cancer? http://www.cancer.org/Cancer/CervicalCancer/DetailedGuide/cervical-cancer-key-statistics. Accessed March 27, 2012.

  5. 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.

  6. National Cancer Institute. SEER Stat Fact Sheets: Cervix Uteri. http://seer.cancer.gov/statfacts/html/cervix.html. Accessed March 27, 2012.

  7. Thomson Reuters. Marketscan. 2009.

  8. 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.

  9. 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.

  10. Screening for squamous cervical cancer: duration of low risk after negative results of cervical cytology and its implication for screening policies. IARC Working Group on evaluation of cervical cancer screening programmes. Br Med J (Clin Res Ed). 1986;293:659-664.

  11. Mandelblatt JS et al. Benefits and costs of using HPV testing to screen for cervical cancer. JAMA. 2002; 287(18):2372-2381.

  12. Centers for Disease Control and Prevention. Human Papillomavirus (HPV). 2010. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, http://www.cdc.gov/hpv. March 27, 2012.

  13. Centers for Disease Control and Prevetion. Diethylstilbestrol (DES) Update. http://www.cdc.gov/des/index.html. Accessed March 28, 2012.

  14. Centers for Disease Control and Prevention. FDA Licensure of Bivalent Human Papillomavirus Vaccine (HPV2, Cervarix) for Use in Females and Updated HPV Vaccination Recommendations from the Advisory Committee on Immunization Practices (ACIP). MMWR May 28, 2010. 59(20);626-629. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5920a4.htm?s_cid=mm5920a4_e. Accessed March 27, 2012.

  15. 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. http://www.uspreventiveservicestaskforce.org/uspstf/uspscerv.htm. Accessed February 23, 2012.

  16. Nuovo J., Melinkow J., Howell LP. New tests for cervical cancer screening. Am Fam Physician. 2001;64(5):780-786.

  17. Saslow D, Solomon D, Lawson HW, et al. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. CA Cancer J Clin. [In press].