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Report: About One-Third of Chemotherapies Used Off Label
A new U.S. study published in the Journal of Clinical Oncology has found that about a third of cancer chemotherapies are used for non-approved indications. National spending for these off-label treatments totals approximately $4.5 billion a year.
Using prescribing information from a database of medical oncologists, the researchers examined the use of the most commonly prescribed anticancer drugs that were patent protected and administered intravenously to patients in 2010. Drug use was considered “on label” if the cancer site, stage, and therapy line met the FDA-approved indication. All other uses were considered “off label.” Off-label use was further evaluated according to whether it conformed to National Comprehensive Care Network (NCCN) Compendium recommendations — a basis of insurer coverage policies.
The researchers found that 30% of claims could be classified as “off label.” Fourteen percent of use conformed to an NCCN-supported off-label indication, while 10% of off-label use was associated with an FDA-approved cancer site but involved an NCCN-unsupported cancer stage and/or line of therapy.
The prevalence of off-label use varied widely. Some anticancer drugs, such as bortezomib and trastuzumab, were generally used on label, whereas other drugs — especially rituximab, gemcitabine, and bevacizumab — were more commonly used off label. The off-label use of bevacizumab was the single largest contributor to the cost of off-label prescribing.
In an accompanying editorial, Dr. Monika Krzyzanowska commented: “The main criticism of off-label prescribing has been the concern that it jeopardizes patient safety because the full risk–benefit ratio is often not completely understood.”
“On the part of payers, there should be greater scrutiny of reimbursement for drugs that are potentially toxic and expensive and are associated with a high proportion of off-label prescribing,” she said.