Health insurers increasingly are paying for a so-called "experimental" treatment for breast cancer-high-dose chemotherapy followed by autologous bone marrow transplant, or ABMT.
Experts and a recent report by the U.S. General Accounting Office say several factors are responsible for the increased willingness of health insurers to pay for the treatment: clinical evidence of the treatment's success, fear of litigation, adverse publicity for denying coverage and state laws mandating coverage.
The GAO and ABMT experts caution, however, that there is no definitive research based on large, random clinical trials about the effectiveness of the treatment. The treatment involves attacking a patient's breast cancer with doses of chemotherapy much higher than those usually used. That dose also kills the patient's bone marrow, so doctors must inject the patient with her own, previously drawn marrow after the chemotherapy is completed.
"There's been a steady increase" in the number of health insurers paying for the treatment, said Karen Illuzzi Gallinari, a partner with Anderson Kill Olick & Oshinsky in New York, which represents group health plans and medical centers in coverage disputes.
"It would appear that more coverage is being offered for this" treatment, agreed Kyl Green, executive vice president of the Health Insurance Association of America in Washington. However, the HIAA does not have data on how many of its members cover the treatment.
"As a general principle, I find increased willingness" on the part of health plans to pay for ABMT, said Roy Jones, M.D., director of the bone marrow transplant unit of the University of Colorado Health Sciences Center in Denver.
"It's extremely likely self-funded employer plans or indemnity insurers will reimburse for this," he said. Among HMOs, "many do, but many do not" pay for the treatment.
The GAO based its conclusions on information collected from 12 health insurers: Aetna Health Plans, Anthem Health Plan of Florida, Blue Cross and Blue Shield of Oregon, CNA Insurance Cos., Harvard Pilgrim Health Care, HealthGuard of Lancaster, HealthPartners, Kaiser Permanente, Mutual of Omaha Insurance Co., Prudential HealthCare Group, United HealthCare Corp. and United HealthCare of Ohio.
ABMT has been performed in this country since the early 1980s, Jones said. "Tens of thousands have received this treatment for breast cancer in the United States," he said.
An estimated 4,000 breast cancer patients received ABMT-which costs between $80,000 and $150,000-in 1994, the GAO said.
But "most of the medical literature and nearly all of the experts we spoke with said the current data are not yet sufficient to make definitive conclusions about the effectiveness of ABMT and about which groups of breast cancer patients would be most likely to benefit," the GAO report said.
"Although there are wide differences of opinion about the appropriate use of ABMT, nearly all sides of the debate agree that the results of randomized clinical trials are needed to provide definitive data on the treatment's effectiveness," the report said.
The National Cancer Institute is sponsoring three clinical trials in which breast cancer patients are assigned randomly to a group for either conventional treatment or ABMT. Enrollment is small because breast cancer patients can receive ABMT in so many places without participating in a clinical trial, experts explain.
Several experts suggested ABMT should be done only in certain hospitals so research results based on a larger number of cases can be obtained.
However, physicians must tell health insurers ABMT is a treatment-not research-so insurers will cover the cost, Jones said.
One expert called ABMT overrated. "The entire perception that this is a therapy that is going to improve health status or provide a cure is technically wrong," said Jeffrey Lerner, vice president for strategic planning at ECRI, a not-for-profit technology assessment agency in Plymouth Meeting, Pa. "If you look at the evidence, people will live longer with" conventional therapies for breast cancer than with ABMT.
Last year ECRI published an analysis of medical literature saying the overall survival rate for metastatic breast cancer patients was no greater for those receiving ABMT than for those receiving conventional treatments.
The 12 health insurers contacted by the GAO said although they normally don't pay for experimental treatments, they cover ABMT for breast cancer because "it has become widely used and*.*.*.*the existing research suggests it may be beneficial to certain patients."
But, the report said, the "insurers told us a variety of nonclinical factors also strongly influenced their coverage policy, such as the threat of litigation, public relations concerns and government mandates."
Before changing policies to cover ABMT for breast cancer, half the insurers contacted by the GAO had been sued for denying coverage for the treatment, the report said.
Health insurers increasingly are paying for ABMT because "they're tired of being sued and there's so much public pressure to pay for this," Lerner said.
Ten states as of December 1995 had laws requiring insurers to cover ABMT for breast cancer patients. "Some of these laws are mandates requiring that coverage of ABMT for breast cancer be part of any basic package of health insurance," the report said. "Other laws simply require that the treatment be available as a coverage option, at perhaps a higher premium."
Five other states as of late last year were considering legislation on ABMT coverage for breast cancer patients.