Effective Nov. 1, insurance giant UnitedHealthcare took steps to curtail what it considers to be extensive misuse of bevacizumab (Avastin).
UnitedHealthcare's oncology analytic team used the 2009 claims data to quantify the extent to which oncologists are using the drug outside the treatment guidelines published by the National Comprehensive Cancer Network.
“Half the Avastin we paid for 2009 did not meet the specific rules of NCCN,” said Lee N. Newcomer, MD, UnitedHealthcare's Senior Vice President-Oncology.
Since 2008, UnitedHealthcare has used the NCCN Drugs & Biologics Compendium, which is based on the NCCN practice guidelines, as the basis for its chemotherapy coverage. UnitedHealthcare paid claims if a patient's diagnosis matched to a drug listed in the compendium.
Two things have changed: UnitedHealthcare is now using a specialized oncology team to analyze claims data and it has technology that allows it to assess drug combinations, line of therapy, and treatment beyond progression when it is reviewing claims for Avastin.
Prior authorization for Avastin is not required, but beginning this month UnitedHealthcare will reject claims that do not comply with the NCCN Compendium specifics regarding treatment regimen and/or line of therapy. (See box.)
Dr. Newcomer said most comments have been supportive of the new rules, but the company did make several changes based on the feedback.
FDA Reviews Avastin
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.”
Lowell E. Schnipper, MD, the Theodore and Evelyn Berenson Professor of Medicine at Harvard Medical School and Chief of the Hematology/Oncology Division at Beth Israel Deaconess Medical Center, said he expects payers to force oncologists to practice evidence-based medicine if they do not do it on their own initiative.
Although circumstances sometimes justify treatments outside accepted guidelines, those situations are limited, he said.
“For the majority of clinical circumstances in which Avastin—or any other agent—is going to be used, there needs to be evidence to support the utilization.”
Following evidence-based guidelines protects the patient from being subjected to toxicity by agents that are unlikely to offer clinical benefit. And for expensive agents, the use of evidence-based guidelines can prevent a patient from paying huge copays for something does not work.
“Why would anybody want a patient to be exposed to the risk of a large financial obligation for an agent that hasn't been proven to be useful?” said Dr. Schnipper, who chairs the American Society of Clinical Oncology Cost of Cancer Care Task Force.
Many Oncologists Routinely Disregard Evidence in Some Cancer Scenarios
The logic of the argument for evidence-based medicine stands in contrast to actual medical practice. While no one tracks the overall rate of compliance with evidence-based guidelines, Dr. Schnipper says many oncologists routinely disregard evidence in some cancer scenarios.
For example, the guidelines published by both NCCN and ASCO state that, for breast cancer patients treated in the adjuvant setting, there is no clinical benefit to repeated bone scans, CT scans, and measurement of tumor markers, if a patient has no specific symptoms.
“And yet we hear from the field that this is a really widespread activity, despite the presence of guidelines from multiple organizations being very clear about it,” he said.
Dr. Meropol, the lead author of ASCO's guidance statement on the cost of cancer care, wants payers to have no reason to take treatment decisions into their own hands. That means leadership in promoting and adhering to evidence-based medicine.
“The more we base our practice on evidence from clinical trials, the less likely we are to face draconian measures by payers that will result in limitation of what might, in some cases, be appropriate therapy,” he said. “As oncologists, we need to police ourselves.”