ThinPrep gains momentum as Pap test alternative
FDA approves ThinPrep for HPV testing
The ThinPrep Pap Test, from Boxborough, MA-based Cytyc Corporation, already acknowledged for its superior accuracy compared with the conventional Pap test, is finally making significant strides toward becoming the industry standard, thanks to the following recent developments:
• In October 1997, the Northfield, IL-based College of American Pathologists concluded in a position paper that "the thin layer preparation methodology (ThinPrep) can improve the accuracy of Pap examinations." Based on its conclusion, the College formally recommended that Medicare and private payers reimburse for the test "at a level that reflects its costs. Coverage and adequate payment are essential if women are to receive the benefits of this significant new technology."
• A month earlier, the federal Food and Drug Administration (FDA) approved testing for human papillomavirus (HPV) directly from the ThinPrep collection vial, effectively expanding the value of the ThinPrep system to laboratories. "Most of what the carriers use to justify cost-effectiveness is your FDA approval," says Patrick Sullivan, president and CEO of Cytyc. "So even though we had this capability and had done many studies on this, they didn’t count it. The fact that we’ve been approved for that indication is yet another step forward in this whole reimbursement environment." ThinPrep won FDA approval as a replacement for the conventional Pap test in May 1996.
• In November 1997, at the annual meeting of the American Society of Cytology in Boston, a study of 50,000 Australian patients was presented, offering further evidence that ThinPrep represents a significant improvement over the traditional test in the detection and clinical management of cervical abnormalities. According to the study, the ThinPrep test cut the number of inadequate specimens by almost 80% compared with the conventional Pap test. The findings echo those of a smaller study published in the August issue of Obstetrics and Gynecology.
• Also in November, Blue Cross and Blue Shield of Rhode Island expanded its coverage to include the ThinPrep Pap Test for cervical cancer screening. More than a dozen major health insurers now provide coverage for the test, including United Health Care, Kaiser Permanente in Texas and the Mid-Atlantic region, several Blues, and Pacificare and Cigna in Denver and Salt Lake City. About 500 laboratories currently use the ThinPrep technology. "What I would expect to occur is that you’ll see the regional plans adopt it because it’s a smaller and more focused decision on their part to start to provide reimbursement before the national plans," Sullivan says.
Cost is the No.1 issue
The main obstacle to securing widespread reimbursement for the test has been cost. ThinPrep is about ten times more expensive than the conventional test, with processors costing $40,000 each and collection vials going for about $9 each. Compounding the cost problem is the fact that "the Pap smear has been used as a loss leader in laboratories," Sullivan says. "Nearly every laboratory loses money today on Paps. The reason they’ve done that is they bundled the test with other tests that they thought they could make money on. And that’s driven reimbursement levels down for the Pap smear."
Sullivan stresses, however, that it’s more important to look at cost-effectiveness than raw costs when assessing the ThinPrep technology. "If you look at finding the disease earlier in the disease process and treating it more cost-effectively and less aggressively, you’re able to save money," he says.
He adds that pharmacoeconomic studies on the new test suggest a savings of between $18 and $20 per case over the conventional test. "That’s all due to doing fewer hysterectomies and fewer aggressive procedures," he says. "Because when you compare it to the sensitivity of the conventional Pap smear, you’re finding the disease sooner and treating the patient more appropriately." (See "Is aggressive treatment really indicated for mild Pap test abnormalities?" Disease State Management, May 1997, pp. 53-56.)
A second consideration is that the ThinPrep test results in fewer "satisfactory but limited by" (SBLB) diagnoses, Sullivan contends. For example, a traditional Pap test may appear negative, but the cytologist may not be fully confident in that conclusion because the sample has been compromised by blood, mucus, or an insufficient number of cells present on the slide. As a result, he or she may qualify the diagnosis with a mark of SBLB.
"In clinical trials, we reduced the number of inadequate samples by about 50%," Sullivan says. That translates into fewer repeat office tests to confirm an original diagnosis. "And when you run that through the economic model, it’s a savings of anywhere from $2 to $5 per patient per year," he says.
[For more information about ThinPrep, contact Cytyc Corporation, 85 Swanson Road, Boxborough, MA 01719. Telephone: (508) 263-8000.]
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