Guidelines on the use of a controversial breast cancer therapy drew criticism and praise last week, although their content isn't known yet.
The guidelines outline when women with breast cancer should have high-dose chemotherapy followed by bone-marrow transplants to revive their then-decimated immune systems.
The high-cost therapy, abbreviated HDC/ABMT, is the subject of intense debate and lawsuits. Many women with advanced breast cancer view it as their last hope. Many insurers, however, often won't pay for the procedure-which can cost from $100,000 to $300,000, depending on treatment time-because researchers still are investigating whether it actually prolongs or improves patients' lives.
Salick Health Care, a Los Angeles-based chain of 10 cancer-treatment centers, said it's seeking publication for the guidelines in a national medical journal. They were developed by Value Health Sciences, which asked nine physicians to rank the appropriateness of the treatment in 1,200 hypothetical situations. The Avon, Conn.-based company has a national reputation for statistical analyses of expert opinion.
The analysis will quantify physician opinion but will not involve any new clinical trials.
The two companies said they're tackling other controversial cancer therapies, too, to help insurers determine when to pay for treatments and physicians to decide when to recommend them.
Salick will use the guidelines in its managed-care program when payers want them to, said Bernard Salick, M.D., its chairman and chief executive officer.
Although many payers and providers have HDC/ABMT guidelines of their own, Salick and some industry experts see its effort as more objective.
"It is an excellent example of how to handle coverage decisions in a national way," said John Cova, the Health Insurance Association of America's consultant on HDT/ABMT.
Some critics, however, object to any guidelines for the use of an investigational treatment.
"The presence of guidelines implies that you know enough to determine appropriate uses," said David Eddy, M.D., professor of health policy and management at Duke University. "If there are no clinical data showing effectiveness-and I agree that is the case-then the treatment is investigational, and it would seem there is no need for guidelines."
Insurers shouldn't pay for investigational procedures outside of studies to determine their value, Dr. Eddy said. "Every penny an insurer pays out for a treatment of uncertain value is a penny taken from other members," he said.
"I find this development troubling," added David Tennebaum, specialty networks director at the Blue Cross and Blue Shield Association in Chicago. "In the absence of scientific evidence, to do a very good job of quantifying physician opinion isn't that valuable."
Most Blues plans won't pay for HDC/ABMTs for breast-cancer patients because they consider it investigational, Mr. Tennebaum said. The controversy surrounding the treatment, however, has led 16 Blues plans to help pay for clinical trials.
The National Cancer Institute trials are at least two years from completion, said Robert P. Gale, M.D., Salick's director of bone-marrow transplantation and an associate professor at the University of California-Los Angeles. Some of the trials are struggling to enroll patients-and might never be completed-because many women don't want to risk not receiving the treatment in a randomized trial, Dr. Gale said. He added that because the treatment is being offered outside of trials, guidelines are needed now.