More support voiced for cancer screening test

Expect to see more insurance coverage of a recently released cervical cancer screening test now that it has been included in just-published practice guidelines issued by the Washington, DC-based American College of Obstetricians and Gynecologists (ACOG).1

Shipment of the DNAwithPap test, manufactured by Digene Corp. of Gaithersburg, MD, began in June 2003, confirms Albert Fleury, company spokesman. The Food and Drug Administration approved the method, which combines the company’s Hybrid Capture 2 High-Risk HPV (human papillomavirus) DNA test with a Pap test, in March 2003 as a primary screening option for women 30 years of age and older. (Contraceptive Technology Update reported on the test’s approval in its June 2003 article, "Get ready to take cervical cancer screening to the next level," p. 61.)

"By the end of June, we had signed up over 20 [insurance] plans, covering 15 million Americans, to reimburse for our new indication," he reports.

More insurance reimbursement will come as welcome news for women, since the new test costs more than the conventional Pap test. Digene’s combined test costs $50 to $60, compared with $14 to $30 for a Pap-only test.2  

Up to 20% of the sexually active U.S. population is believed to be infected with HPV at any one time; many women who become infected with the virus are able to eradicate it with no apparent long-term consequences to their health.3 Some women, however, develop a persistent infection that eventually can lead to precancerous changes in the cervix.

Almost all cervical cancers are caused by HPV. According to the Atlanta-based American Cancer Society (ACS), 12,200 women will be diagnosed with cervical cancer in 2003 and 4,100 will die from the disease.3 Screening is an important tool in the fight against the disease.

The new ACOG guidance calls for the first screening of cervical cytology to begin by approximately three years after first sexual intercourse or by age 21, whichever comes first. This recommendation differs somewhat from earlier guidance, which called for screening by the onset of sexual activity or by age 18, whichever occurred first.

Women up to age 30 should undergo annual cervical cytology screening, advise the new guidelines. According to ACOG, the addition of age guidelines is an important one, since women younger than age 30 have a higher likelihood than older women of acquiring high-risk types of HPV that cause premalignant cervical disease that should be ruled out before extending the testing intervals.

For women age 30 and older, the guidelines offer two acceptable screening options for women in this age group. Under either of the following options, women may not need annual screening:

• Testing using cervical cytology alone: If a woman age 30 or older has negative results on three consecutive annual cervical cytology tests, then she may be rescreened with cervical cytology alone every 2-3 years, according to the ACOG guidelines.

• The combined use of a cervical cytology test and an FDA-approved test for high-risk types of HPV: Once women test negative on both tests, rescreen with the combined tests no more frequently than every three years, advises ACOG. If only one of the tests is negative, however, more frequent screening will be necessary. Higher-risk women may require more frequent rescreenings. Higher-risk women include those who are infected with HIV, are immunosuppressed (such as kidney transplant recipients), were exposed to DES (diethylstilbestrol, a synthetic form of estrogen prescribed between 1940 and 1971 to help women with certain complications of pregnancy) in utero, or were previously diagnosed with cervical cancer.

Women who have had a hysterectomy with removal of the cervix for benign reasons and have no history of abnormal or cancerous cell growth may discontinue routine cytology testing, according to the guidelines. Women who have had such a hysterectomy but who have a history of abnormal cell growth (classified as CIN 2 or 3) should be screened annually until they have three consecutive, negative vaginal cytology tests; then they can discontinue routine screening.

When to stop screening?

When can clinicians stop providing cervical cancer screening? Providers can determine on an individual basis when an older woman can stop having such screening, based on such factors as her medical history and the provider’s ability to monitor the patient in the future, the ACOG practice bulletin states.

This recommendation differs slightly from those issued by the ACS and the U.S. Preventive Services Task Force. ACS calls for cessation of testing in non-high-risk women at age 70, and the task force specifies by age 65. Due to limited studies of older women, it is difficult to set an across-the-board upper-age limit for cervical cancer screening, states ACOG; the recommendation is just "a difference in expert opinion," states Alice Kirkman, ACOG spokeswoman.

References

1. American College of Obstetricians and Gynecologists. Cervical Cytology Screening. Washington, DC; 2003.

2. Barbaro M. Doctors Endorse Digene Test. The Washington Post. Aug. 1, 2003; E01.

3. Food and Drug Administration. FDA Approves Expanded Use of HPV Test. Bethesda; March 31. Accessed at www.fda.gov/bbs/topics/NEWS/2003/NEW00890.html

Resource

For more information on HPV testing, contact: Digene Corp., 1201 Clopper Road, Gaithersburg, MD 20878. Telephone: (800) 344-3631 or (301) 944-7000. Fax: (301) 944-7121. Web: www.digene.com  or www.thehpvtest.com