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Note: This report is greater than 5 years old. Findings may be used for research purposes but should not be considered current.

Overview

Fewer than 50 percent of beneficiaries with bevacizumab orders had a cancer diagnosis in the prior 6 months. This was driven by the biologic's off-label use in degenerative eye disorders.

While 83 percent of beneficiaries with erlotinib orders had a prior cancer diagnosis indicative of its use in lung cancer (a labeled indication), 69 percent had diagnoses indicative of its use in secondary malignancies and/or head and neck cancer (an off-label use).

Nearly all (98 percent) beneficiaries with Bacillus Calmette-Guerin (live) orders had a cancer diagnosis indicative of its use in malignant neoplasms of the genitourinary tract (e.g., bladder cancer).

The treatment of cancer has expanded considerably from surgical procedures to chemotherapy agents and radiation, and most recently, to the use of biologic products. Although the first biologic was approved in the early 1980s, the use of these agents in the treatment of cancer is still relatively new. The type of biologic, or immunotherapeutic agent, used to treat cancer varies depending on the diagnosis.

Not all biologics are Food and Drug Administration-labeled (i.e., indicated) for the conditions in which they are used. In fact, the off-label use of cancer therapy was estimated to reach 50 to 75 percent by 2005, according to the National Comprehensive Cancer Network. Such use is not uncommon in cancer patients who have failed more traditional treatments. The fee-for-service (FFS) Medicare program developed guidelines for medically accepted off-label use of anticancer biologics, using published drug compendia, in an effort to identify which anticancer treatments are outside the scope of Medicare coverage. These guidelines were the result of a 1993 congressional act and have since been updated to integrate information from five various compendia providers (American Hospital Formulary Service Drug Information, DrugPoints, Clinical Pharmacology, DRUGDEX, National Comprehensive Cancer Network Drugs and Biologics Compendium). This update was completed with input from the public and the Centers for Medicare & Medicaid Services' (CMS) Medicare Coverage Advisory Committee (MCAC). While the off-label use of cancer therapies among the Medicare population would be expected, little is known about the distribution of diagnoses for which anticancer biologics are used.

The goal of this brief is to examine the types of cancer for which anticancer biologics are used, as identified in Medicare Parts B and D claims. The report focuses on biologics among monoclonal antibody, kinase inhibitor, biologic response modifier, other immunosuppressive and immunomodulator, and miscellaneous biologic nonblood product classes. Information on the general utilization and cost of these biologics can be found in a companion Data Points.

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