Off-label use of Colorectal Cancer Drugs

This national coverage determination (NCD) was implemented April 18, 2005.  The NCD states that “Oxaliplatin (Eloxatin™), irinotecan (Camptosar®), cetuximab (Erbitux™), and bevacizumab (Avastin™) are anti-cancer chemotherapeutic agents approved by the Food and Drug Administration (FDA) for the treatment of colorectal cancer. Anti-cancer chemotherapeutic agents are eligible for coverage when used in accordance with Food and Drug Administration (FDA)-approved labeling (see section 1861(t)(2)(B) of the Social Security Act (the Act)), when the off-label use is supported in one of the authoritative drug compendia listed in section 1861(t)(2)(B)(ii)(I) of the Act, or when the Medicare contractor determines an off-label use is medically accepted based on guidance provided by the Secretary (section 1861(t)(2)(B)(ii)(II).”

Pursuant to this national coverage determination, the off-label use of clinical items and services, including the use of the studied drugs oxaliplatin, irinotecan, cetuximab, or bevacizumab, are covered in specific clinical trials identified by the Centers for Medicare & Medicaid Services (CMS). The clinical trials identified by CMS for coverage of clinical items and services are sponsored by the National Cancer Institute (NCI) and study the use of one or more off-label uses of these four drugs in colorectal cancer and in other cancer types. The list of identified trials is on the CMS website at: /coverage/download/id90b.pdf.

Decision memo