Health Care: Preventive Procedure Is for Women At High Risk for Disease
At UCSD and Sharp HealthCare facilities women can now take a test to detect abnormal cells that put them at a higher risk for cancer when mammograms show up normal.
The problem is most major California health insurers have yet to pay for the costly procedure.
The test, called ductal lavage, is intended for women with a high risk for developing breast cancer, said Dr. Anne Wallace, director at UCSD’s Breast Cancer Center.
That is women who are genetically predisposed to developing the disease or have a close relative who developed breast cancer, she said.
An estimated 5 million women in the United States are at high risk, either because they had the disease or have a family history, experts say.
Wallace said ductal lavage holds the promise of a better cell-collection method.
Scientists have long learned that precancerous changes can be seen in cells collected from the milk ducts. Retrieving the cells, however, has always been problematic.
The conventional method uses a 3-inch needle to probe ducts randomly, said David Hung, president and CEO of Pro-Duct Health, the Menlo Park firm which developed the test.
Ductal lavage, by contrast, is “non-invasive” and not painful, he said.
It uses various steps and devices to collect cells from the ducts.
First, patients smear a cream on their breast to numb it. The next step is to use a suction cup similar to a breast pump to bring up fluid in one of several ducts. A catheter is inserted into the fluid-producing duct where it releases more anesthetic. Then saline is squirted through the catheter to wash away cells along the duct.
The doctor collects the sample and sends it to the lab.
Hung said total costs for the procedure range between $400 and $700.
Wallace, who has tested 20 women since the procedure made its way to UCSD in January, has a bleak outlook on insurance coverage.
“Breast cancer is grossly under-reimbursed It will be tricky to get the whole costs of the catheters (numerous ones are used in ductal lavage) covered,” she said.
Waiting For Evidence
Three major health insurers did not cover the procedure as of July 17.
Blue Shield of California in San Francisco, PacifiCare Health Systems, Inc., in Santa Ana, and Health Net in Woodland Hills cited “insufficient scientific evidence.”
Michelle Naiditch, a spokeswoman for Blue Shield, said the insurer reviewed ductal lavage last month and found it lacked scientific evidence of being an effective procedure.
PacifiCare spokeswoman Cheryl Randolph and Health Net spokesman Brad Kieffer said there isn’t enough published data is available on ductal lavage.
Wang, however, said a study is due to appear in a renowned medical journal this fall. Pro-Duct declined to disclose the name of the oncology journal prior to publication.
The hope, however, is the published data will persuade insurers to cover ductal lavage.
Wang said the study of 507 women funded by Pro-Duct Health found 24 percent of women who underwent ductal lavage have abnormal results.
Still, Dr. Robert Barone, director of surgical oncology at Sharp, who has been offering the test to women at Sharp Oncology Center in Kearny Mesa, remains skeptical.
“We don’t know how useful the procedure is,” Barone said.
He wants Pro-Duct to do comparative studies to see how ductal lavage measures up against other early-detection cancer tests.
“I use Magnetic Resonance Imaging in patients that feel they have a lump if a mammogram and ultrasound is negative,” he said. “If you select out the high-risk patients, it’s something that may be of use. But it should be the standard of care needs to be proven.”
Different Effects
He said another big drawback is that ductal lavage doesn’t work on all women.
Women have between six to eight ducts per breast, but not all produce fluid.
“Sometimes you have to probe one to four ducts before you get a drainage,” Barone said. The device to probe one duct costs $300. To probe four ducts would run $1,200 , and that is excluding doctors’ fees.
Barone said he will continue to offer the test to women. He said up to 70 percent of women decline the test after they find out insurers may not cover the procedure.
Helene Henager, 46, a nurse who lost her mother and two aunts to breast cancer, said she wouldn’t have a problem paying out of her own pocket for a test that can detect breast cancer early.
Henager said she first heard about ductal lavage on television, then underwent the test at UCSD.
When asked about the procedure, Henager said she didn’t feel any pain, just a little discomfort when the saline filled her breast.
Wallace believes ductal lavage can help women like Henager evaluate the options in reducing the breast cancer risk.
“If you have a woman who is 50 years old and carries a gene breast cancer gene had a normal mammogram and ultrasound, this may help her make the decision (whether) to go on tamoxifen (a drug to prevent and delay cancer recurrence) or have prophylactic mastectomy.”
Both, Kaiser Permanente and Scripps Health said they do not offer ductal lavage at this time, because it hasn’t been widely studied.
