Department of Medicine

Oncology Times | November 10

UnitedHealthcare’s action comes as bevacizumab faces new scrutiny from the Food & Drug Administration. In 2008, the FDA gave accelerated approval for Avastin to treat metastatic breast cancer. Subsequent studies, however, showed that the benefit of adding the agent to other chemotherapy agents was smaller than the original study had suggested.

In July, the FDA’s Oncologic Drugs Advisory Committee voted not to expand the label for Avastin, as its manufacturer had sought, but rather to remove the breast cancer indication entirely. The FDA is expected to announce its decision on Dec. 17. That decision will not affect the FDA’s approval of Avastin for lung, kidney, brain, and colorectal cancers.

The FDA’s pending decision about Avastin is unrelated to UnitedHealthcare’s plan. But the unusual scenario underscores the question that oncologists, patients, and payers are all wondering about: Does a therapy do what its promoters say it will do?

Neal J. Meropol, MD, the Dr. Lester E. Coleman, Jr. Professor of Cancer Research and Therapeutics and Chief of the Division of Hematology and Oncology, University Hospitals Case Medical Center and Case Western Reserve University, said UnitedHealthcare’s move may signal a new era for the coverage of cancer therapies.

“Now that individual treatments have become so costly, it’s no wonder that increased scrutiny is being applied to their use,” he said. “I imagined that it was only a matter of time before insurance carriers would start to decline payment for high-cost treatments of uncertain benefit.”

Some observers call bevacizumab a miracle drug, while others deride it as a big waste of money. But Dr. Meropol said the scientific evidence does not support either claim.

“All we know is that in the ‘average’ patient with colon cancer, lung cancer, kidney cancer, there is some benefit to Avastin. Within those groups, there are many patients who don’t benefit at all, and some patients who benefit dramatically,” Dr. Meropol said. “The fact is that Avastin may be a miracle drug for some patients with cancer, and may be of no benefit, and perhaps harm, in other patients.”

That uncertainty about Avastin’s benefit is pitted against a known fact: a monthly wholesale price of more than $7,000.

That price tag would probably not be controversial if oncologists were in consensus that the drug offered a meaningful benefit for their patients. Instead, as Harold J. Burstein, MD, PhD, a breast cancer expert at Dana-Farber Cancer Institute and Brigham & Women’s Hospital points out, none of five clinical trials suggest a survival advantage for using Avastin for patients with advanced breast cancer.

He believes oncologists’ love/hate relationship with Avastin stems from America’s unwillingness to weigh the costs and benefits of therapeutic options.

“We need a clearer set of benchmarks and we need a process that allows us to weigh the worthwhile-ness of a drug—that is, its benefits, its costs, its side effects—in addition to just the clinical data,” he said. “And we need a more transparent process to do that.”